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BD FACS Sample Prep Assistant III
Automated flow cytometry sample preparation
Walkaway sample preparation
The BD FACS™ Sample Prep Assistant (SPA) III
automates flow cytometry sample preparation
for clinical and research labs using the
BD FACSCanto™ or BD FACS Calibur™
flow cytometers.
The SPA III now supports a wider variety of
blood collection sample tubes including several
configurations of BD Vacutainer®, Streck
Cyto-chex®, and Sarstedt products to accommodate a range of incoming sample tube types.
The SPA III maximizes lab work flow
efficiency by automating sample preparation
steps and improving processing time up to
30% over the SPA II. The SPA III also allows for
flexibility in automating predefined BD panels
or user-defined custom assays.
Find out more about how the SPA III, with its
proven sample preparation capabilities, can help
your lab operate with optimal efficiency and
cost savings.
For In Vitro Diagnostic Use.
BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. © 2009 BD
23-11030-00
BD Biosciences
2350 Qume Drive
San Jose, CA 95131
answers@bd.com
bdbiosciences.com
Efficiency Expert.
Every lab needs one.
3500 Series
Genetic Analyzer
Are you that type? Always looking for ways to simplify and streamline lab
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FOR RESEARCH USE ONLY. Not intended for any animal or human therapeutic or diagnostic use.
© 2010 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners.
For those who require IVD-marked devices, the 3500 Dx and the 3500xL Dx Genetic Analyzers and system accessories meet the requirements of the In Vitro Diagnostics Medical Devices
Directive (98/79/EC). The 3500 Dx and 3500xL Dx systems are for distribution and use in selected countries only, and are not for sale in the United States of America.
Contents
advance for Administrators of the
LABORATORY
July 2010 vol. 19, nO. 7
cover story
Biomarkers in
Prevention of
CVD and Stroke
Will emerging biomarkers
improve risk stratification?
By Mary M. Kimberly, PhD
About the cover:
Research that explores inflammatory,
renal and other markers is ongoing.
 Denotes
interactive
content
Val Costanzo
features
32 Allergy
Testing
On the Rise
As allergy rates increase, clinical laboratories have a
unique diagnostic opportunity.
By Kathy Braniff, MSA, MT(ASCP), Jason A. Kendall,
MT(AMT), and Safedin “Sajo” H. Beqaj, PhD, HCLC, CC(ABB)
38 e
AG and A1c in
Diagnosing Diabetes
The laboratory’s continuing role in detecting and following
diabetic patients is explored.
By David Plaut
44 Advancing Patient Safety
Patient safety requires a collaborative effort
between man and machine.
By Jill Hoffman
48 C
onfigurations,
Considerations of Outreach
How to maximize your laboratory's potential
for outreach testing.
By Lynn Nace
52 E
fficiencies of Cellular Analysis
Improvements obtained form digital morphology
are explored.
A Staff Report
Copyright 2010 by Merion Matters. All rights reserved. Reproduction
in any form is forbidden without written permission of publisher.
advance for Administrators of the Laboratory® (ISSN 1096-6277) is published monthly by Merion
Matters, 2900 Horizon Drive, Box 61556, King of Prussia, PA 19406. Periodicals Postage Paid at
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61556, King of Prussia, PA 19406; Ads: (800) 355-5627; Editorial: (610) 278-1400; Fax: (610)
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ADVANCE also serves the health care field with publications for: Physical Therapists, Directors of
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Postmaster: Send address changes to: advance for Administrators of the Laboratory,® Circulation,
Merion Matters, 2900 Horizon Drive, Box 61556, King of Prussia, PA 19406.
Professionals, Medical Laboratory Professionals, Health Information
ADVANCE is free to qualified administrators of clinical laboratories. Reach us at: 2900 Horizon Drive, Box
Acute Care, and Nurses.
4 JULY 2010 • advance /Laboratory • www.advanceweb.com
Professionals, Physician Assistants, Nurse Practitioners, Providers of Post-
Get the free mobile app at
http:/ / gettag.mobi
advanceweb.com/labmanager
online
Contents
features
57 Validation, Verification
Of Method Comparison
Quality management and the role of performance standards
are addressed in this series debut.
By Carol R. Lee, MS, and David G. Rhoades, PhD
62 Value of Vitamin D
The list of benefits of this impressive nutrient continues
to grow.
By Kelly J. Graham
68 Next-Gen Prenatal Testing
An integrated approach focuses on maternal and
fetal well-being.
By Luis LaSalvia, MD, MBA
72 A
nnual Analyzers Buyers Guide
This comprehensive guide includes descriptions on test menus,
special features and more.
A Staff Report
PEDIATRIC ALLERGY TESTING
Allergists in
the U.S. have observed a noticeable increase in pediatric
allergy cases in the last decade. Skin testing remains the
most common diagnostic technique, but blood testing is
growing in popularity as it requires one blood draw instead
of the uncomfortable experience of keeping a child still for as
many as 70 skin pricks. The blood test also offers increased
sensitivity. In this article, we explore the benefits and
downfalls of both methods.
 PRINT COMPLEMENTS
• “Snap” the bar codes in this issue with your smart phone
to see extended discussions of print articles online!
• More on allergy testing
• Patient safety resources
• More on vitamin D
 ONLINE EXCLUSIVES
• AACC/ASCLS Coverage: Before, during and after
the show, count on ADVANCE to bring you details on
educational sessions and exhibit hall technology.
• Building a Lean Pathology Lab: A Case Study
• Age and Cytokine Expression in the Breast Cancer
Blood Test
• PCA3 Testing for Prostate Health
 CHECK BACK DAILY!
• Expert Blogs
• Daily News Watch
• Exclusive Columns
DEPARTMENTS
10 Editorial
ADVANCE Goes Interactive
12 The Molecular Edge
Mainstream Adoption of MDx
16 Department Dollars
4 Steps to Internal Audit Success
18 Perspectives in Pathology
Blood Management
20 At the Bedside
Defining Analytical Accuracy
22 Automation Alert
Safety, Cost Efficiencies
24 Leadership Outlook
Evaluation Tools
PRODUCT SECTION
90 Lab Technology
Identifying Rare KRAS Mutations
92 Lab Limelight
AP Data Reporting
96 Case Study
Challenges in Special Hemostasis Testing
98 New Technology
• Community Forum
• Product Releases
• Multimedia Features
next Issue:
MDx Buyers Guide
6 JULY 2010 • advance /Laboratory • www.advanceweb.com
© 2010 Thermo Fisher Scientific Inc. Copyrights in and to the main photograph are owned by a third
party and licensed for limited use only to Thermo Fisher Scientific by Taylored Image.
All under one roof.
The Thermo Scientific brand brings together the resources, expertise
and reputation of some of the most trusted names in the industry.
We provide you with one source for a variety of the products you
need in today’s lab environment.
This year we are driving bold progress with innovations that are
improving workflow in the lab, providing greater accuracy of results,
and enhancing patient care.
Learn more at www.thermoscientific.com/diagnostics and
www.thermoscientific.com/particletechnology.
Come see us at the AACC Clinical Lap Expo, island #2415!
Moving science forward
We’re here to help you!
For more information on Thermo Scientific
Clinical Diagnostic products, contact our
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advertiser Index
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Our searchable online Resource Directory allows you to receive detailed information about the companies and
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Support the companies that support your profession.
The companies listed below support the laboratory profession by placing advertisements in ADVANCE for
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* Denotes interactive content
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AB Sciex. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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ADVANCE Healthcare Shop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advanced Instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advanced Instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alfa Wassermann Diagnostic Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
American Medical Technologists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*American Proficiency Institute. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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BD Biosciences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BD GeneOhm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*Beckman Coulter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Beckman Coulter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Beckman Coulter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Beckman Coulter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Benetech Clinical Software Solutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bio-Rad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bio-Rad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bio-Rad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bio-Rad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CellaVision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*Cleveland Clinic Laboratories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data Innovations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*Dawning Technologies Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
diaDexus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostica Stago. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Genzyme Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Idaho Technology Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Immunodiagnostic Systems Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
KRONUS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leica Microsystems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maine Standards Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MediaLab Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nova Biomedical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NovoVision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Orchard Software Corp.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ortho Clinical Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ortho Clinical Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pathology Service Associates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*PerkinElmer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Phadia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pro-Lab Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quantimetrix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RAM Scientific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rees Scientific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Roche. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*SCC Soft Computer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*Siemens Medical Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Siemens Healthcare Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thermo Scientific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
website
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www.absciex.com. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
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www.aicompnies.com/anox. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
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www.bd.com/vacutainer/lean_urinalysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
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www.bio-rad.com/qualitycontrol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
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www.datainnovations.com/ee. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
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ADVANCE
Goes Interactive
elcome to our first interactive issue!
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10 JULY 2010 • advance /Laboratory • www.advanceweb.com
Lynn Nace, Editor
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More ways to improve
workflow and quality.
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tookour laboratory to the next level of performance by providing the ease-of-use and
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©2010 Beckman Coulter, Inc. Beckman Coulter and the stylized logo are registered trademarks of Beckman Coulter, Inc. DxLab is a trademark of Beckman Coulter, Inc.
molecular diagnostics
the molecular edge
Mainstream
Adoption of MDx
By Kerri Weinert, Carrie Cresenzi and Andrew Demeusy
espite the difficult economic conditions, the U.S. diagnostic nucleic acid
testing (NAT) market continues to grow due to increased test volumes in
the infectious disease and cancer (HPV and KRAS) testing market segments.
Although historically NAT has been performed in higher volume, highly complex labs, testing is expanding into smaller labs; the number of labs performing
molecular testing continues to increase. This shift is a result of improved technologies and automated instruments building on the desire to improve clinical
outcomes. Many of these institutions, especially those that recently brought
molecular testing in-house, may only perform one or two molecular assays but
expect to expand their offering over the next couple of years.
NAT is often viewed as the future of diagnostics and an area of rapid growth, but
where and how is this growth happening? In the fall of 2009, Boston Biomedical
Consultants surveyed 100 laboratories throughout the U.S. to better understand
the growth in the market. The survey focused on small community hospital laboratories (hospitals with <500 beds) but also captured a representative sample of
medium and large hospitals. Of the 100 respondents, most offer a wide variety of
molecular tests but perform a very limited number of them in-house.
Adoption
The desire to perform molecular testing in-house is driven by several clinical
and economic factors. However, this desire is stymied by high cost, budget constraints and low volume. As such, most institutions begin by bringing in one or
two of their highest‑volume molecular tests and performing the testing in one
of their existing labs, most often microbiology (approximately 70% of respondents), underscoring the legacy of NAT-based sexually transmitted disease testing. Survey results indicate a correlation between the length of time performing
molecular testing and the number of tests performed in-house with laboratories
that have been performing NAT for <2 years conducting only two or three tests.
Within the past few years, the same labs have seen these test volumes increase
significantly—more than 50% experienced high single‑digit or low double‑digit
growth, with ~25% of respondents noting >+10% growth.
Assays that have recently seen rapid growth (i.e., influenza testing) are not
driving the expansion in the market. It is the more developed assays such as CT/
GC and HPV that are performed in small community hospitals. MRSA testing
is being adopted by small hospitals, as they can easily begin testing given available automation, with the Cepheid GeneXpert® frequently cited by respondents.
Within the labs sampled, CT/GC was the test most frequently offered and the
assay experiencing the highest test volumes and fastest rate of growth.
Brand Selection
When choosing a system, most laboratories cited "performance characteristics"
as the most important decision factor; this was followed by price. Within the
­laboratories surveyed, Roche instruments had the greatest presence in the
12 JULY 2010 • advance /Laboratory • www.advanceweb.com
EDITORIAL ADVISORY BOARD
David G. Beckwith, PhD
President, CEO and Clinical Director
Health Network Laboratories LLC, Allentown, PA
Donna D. Castellone, MS
Clinical Project Manager
Siemens Healthcare Diagnostics, Tarrytown, NY
Robin Felder, PhD
Director
Clinical Robotic Research Group
University of Virginia Health Sciences Center, Charlottesville, VA
Wm. Daniel Follas, MS
President
Follas Laboratories Inc., Indianapolis, IN
Gerri S. Hall, PhD
Staff Microbiologist
Department of Clinical Pathology
Cleveland Clinic Foundation, Cleveland, OH
Gerald J. Kost, MD, PhD
Professor, Medical Pathology and Biomedical Engineering Director,
Clinical Chemistry, University of California, Davis
John A. Lott, PhD
Professor of Pathology, Director of Clinical Chemistry
The Ohio State University Medical Center, Columbus, OH
Peggy Luebbert, MS, MT(ASCP), CIC
Risk Management Specialist
Alegent Health Bergan Mercy Medical Center, Omaha, NE
Paul J. Orsulak, PhD, MBA
Senior Vice President and Clinical Director
MEDTOX Laboratories Inc.
Gregory T. Stelzer, PhD
Senior Vice President and Chief Scientific Officer
Esoterix Inc., Brentwood, TN
John G. Thomas, PhD, MS, HCLD
Director, Microbiology and Virology
West Virginia University Hospitals, Professor, Departments of
Pathology and Periodontics, West Virginia University Schools of
Medicine and Dentistry, Robert C. Byrd Health Sciences Center-North,
Morgantown, WV
Gregory J. Tsongalis, phd
Director, Molecular Pathology, Department of Pathology, Dartmouth
Medical School, Co-director, Pharmacogenomics, Dartmouth Hitchcock
Medical Center, Lebanon, NH
Dennis Winsten
President
Dennis Winsten & Associates, Inc., Tucson, AZ
Healthcare Systems Consultants
William E. Winter, MD
Professor, Department of Pathology, Laboratory Medicine
Pediatrics and Molecular Genetics & Microbiology
Medical Director and Section Chief, Clinical Chemistry
Director of Residents Training Program, University of Florida College of
Medicine, Gainesville, FL
Vendor Advisory Board
Automation
Ron Berman
Director of Product Management,
Automation and Information Systems
Beckman Coulter, Fullerton, CA
Coagulation
Jogin R. Wu, PhD
Associate Clinical Professor of Pathology,
Duke University Medical Center, Associate Director,
Duke University Health System, Durham, NC
Hemostasis
KEVIN MCGLINCHEY, MT(ASCP), CLS(CG)
Hemostasis Instrumentation Product Manager, Trinity Biotech
Information Systems
Kerry Foster
Director of Marketing
Orchard Software Corp., Carmel, IN
Point-of-Care Testing
Paul Hausman
Marketing Manager, Institutional Business
Lifescan, Milpitas, CA
Transfusion Medicine/Blood Banking
Christie Newman
Marketing Product Manager
ImmucorGamma, Norcross, GA
The views expressed in articles in ADVANCE for
Administrators of the Laboratory® are those of the authors
and do not necessarily represent the opinions or views of
Merion Publications, Inc.
24 / 7 / 365.
That’s just how we roll.
With over 250 field-based service engineers, application specialists,
application scientists, and 24/7/365 technical phone support, Roche
continues to lead the pack in our commitment to unparalleled customer
service.
Regardless of economic climate, we will continue to develop and
dispatch highly trained specialists to anticipate your laboratory’s needs
today and into the future. And our customer support does not end there.
MyLabOnline.com offers the largest collection of online education for
your staff’s continued professional development. We are committed to
your success, every day.
Leadership. Innovation. Commitment.
MyLabOnline.com
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Draw Quality
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© Copyright 2005, RAM Scientific Inc. SAFE-T-FILL is a
registered trademark of RAM Scientific. SG 9885
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molecular diagnostics
market, reflective of the company's leading market position; the
majority of these instruments are in the larger hospital laboratories which may have several Roche instruments. When looking
at laboratories that have been performing NAT for <2 years, the
most common manufacturer in this group is Cepheid followed by
Roche, Gen-Probe and BD. These
competitors reflect the high vol To view our Guide
ume of MRSA and CT/GC tests
to the Genetics
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performed in the U.S., the high
this bar code on
level of automation offered, as well
your smartphone:
as the lower complexity of qualitative bacterial testing compared to,
for example, a quantitative RNAbased viral test. NAT instruments
are dissimilar to other IVD market instruments in that most have
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limited testing menus; with only a
handful of FDA-approved assays
on any given platform, the need for multiple instruments is high.
Of the 53 small hospital laboratories surveyed, approximately
70% had only one to two instruments; expanding beyond these
responses, that percent declined.
Short‑term Outlook
The expansion of NAT into smaller labs seen in the past few years
is expected to continue for some of the more established/mature
tests. "Molecular diagnostics [NAT] utilization in the U.S. will
continue to improve as increasing levels of automation become
available. Healthcare reform is concerning us, because it may
result in reimbursement cuts, so we are starting to look at cutting
costs by moving toward more automated assays," says John Little,
lab administrative director, Decatur (IL) Memorial Hospital.
Within the next two years, nearly 30% of labs expressed the
intent to expand by increasing the number of tests performed
in-house. Oncology tests, such as KRAS, as well as companion
diagnostics are expected to continue to be "hot" testing categories,
but not among the small hospital labs. The majority of laboratories see high cost as the single strongest barrier to adoption of
molecular testing (of note, reimbursement was the lowest ranked
barrier). Of great surprise were the responses when laboratories
were asked, "What is one test that you would like available as an
FDA-approved test?" More than 40% of labs cited analytes for
which there are currently FDA-approved testing kits available,
such as MRSA, C. difficile and respiratory viral panels. n
Kerri Weinert, Carrie Cresenzi and Andrew Demeusy are
­consultants with Boston Biomedical Consultants Inc.
The Molecular Edge is a series about
practical matters in molecular diagnostics,
sponsored by the Association for
Molecular Pathology (www.amp.org).
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14 JULY 2010 • advance /Laboratory • www.advanceweb.com
Introducing The BD MAX™ System
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BD Diagnostics - Infectious Disease
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finances
department dollars
4 Steps to Internal
Audit Success
By Dennis Arter
our audit of the lab is almost done. You’ve finished
your interviews, looked at all the cal records and
examined the labels, stickers and signatures. Your field
notes are crammed with lots of information. What do
you do with it?
Rather than list a number of major and minor
nonconformities and writing CAPA sheets for each
one, you could show how the lack of system controls
is harming the business via higher costs, lower production and increased risk. Generate improvement
through quality, safety and environmental audits by
following four steps.
Step 1: Data Dump
As the internal audit progresses, your audit team periodically meets to discuss gathered facts and resulting
opinions. As the fieldwork ends, you need a master list of
good (conforming) and bad (nonconforming) facts. Take
a sheet of paper, draw a line down the middle and label
one side good and the other side evil. Now open up your
field notes and call out the conforming and nonconforming facts. What specific instrument was not cal-checked
last Tuesday? When was the SOP last reviewed for adequacy? No fuzzy or judgmental words (e.g., appropriate, adequate or weak) are allowed. The scribe, usually
the team leader, writes it all down. It is important that
there be no analysis, sorting or deep understanding of
the data yet. This is called a data dump, as there is no
intent to analyze the information. You need to get it all
in a central location for the next step.
Step 2: Data Chunk
Examine your data sheets for patterns. Go down the list
of bad facts and find those that are similar; some may be
variations of the same thing or point to a common weakness. Show these related facts by a graphic symbol, such
as a circle, box, triangle, star, etc.
Generally there are two or three big groups of related
facts. This is called data chunking. Facts, both good and
bad, will always cluster. Rarely is there only one instance
of a conforming or nonconforming condition. In other
words, you need to show the disease rather than the
individual symptoms. For example, why are all those
16 JULY 2010 • advance /Laboratory • www.advanceweb.com
labels falling off? How many sample bag deliveries had the same
problem last week? Why is the third shift always low on reagents?
Systems analysis will show that only one or two issues are common to the majority of your gathered facts. These are the things
auditors—and managers—must focus on. Rather than reporting
each nonconforming item, you show how the nonconformities are
the result of a system issue.
Step 3: Show the Pain
Behavior-based quality, safety and environmental management
teach us that humans respond to basic forces of pain and pleasure.
These consequences will cause us to increase the pleasure activities
and decrease the pain activities. We do not wish to be responsible
for higher costs of performing tests. We do not wish to continue
using gloves that tear. We do not want people to have to wait on a
backlog of actions upstream. We do not want to poison our water
or waste fuel. We want to be heroes. We want to help the business
and our fellow workers. We all want sustainability.
Your audit team needs to show the business pain–cost, production or risk–of the diseases found by the above data chunking.
What was the cost of express delivery to get those supplies? How
many people worked overtime last month? How many analyses
had to be done over? If your team can show the pain, those in
charge will try to eliminate it.
Step 4: Develop the Finding Sheet
When you have the problem identified, the pain it is generating
and several specific examples of the condition, put the problem
and pain together, followed by the factual examples underneath.
This goes on one sheet of paper, called a Finding Sheet. Putting
this cause (disease) and effect (pain) statement at the top, along
with actual examples, will convince the auditee to spend effort
and resources to change.
This is systems thinking. Auditors of the future, be they quality,
safety or environmental, must apply pattern recognition (dump
and chunk) and cause/effect analysis (pain and pleasure), which
makes the product of the audit, our report, useful. n
Dennis Arter is consultant and trainer in quality auditing in Kennewick, WA. He earned a bachelor’s degree in chemistry from the
University of Illinois–Champaign-Urbana. Arter wrote Quality
Audits for Improved Performance, 3rd edition and ISO Lesson
Guide 2000 and is an ASQ Fellow, Certified Quality Auditor and
former member of the Board of Directors.
 This ASQ Quality Press book, which details more on steps to auditing success, is available at Quality Audits for Improved Performance: http://www.asq.org/quality-press/display-item/index.
html?item=H1180&author=Dennis%20R.%20Arter. For more free information on quality auditing, see the May issue of ASQ Healthcare Update:
http://www.asq.org/enews/healthcare-update/2010/201005.html.
© 2010 PerkinElmer, Inc. 400164A_01. All trademarks or registered trademarks are the property of PerkinElmer, Inc. and/or its subsidiaries.
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pathology
perspectives in pathology
Blood
Management
By Lowell L. Tilzer, MD, and
Shirley Weber, MHI, MHA, MT(ASCP)
edical management of the clinical laboratory is
one of the important duties of pathologists. An
important reason pathologists are paid for Medicare
Part A services by the hospital is to ensure proper use
of blood and blood components. Transfusion services
is one of the highest cost centers in the clinical lab. But
more important than cost, transfusion safety depends
on the pathologist getting the message to clinicians that
blood should be used at the right time and in the right
amount and that the correct component is essential.
The field of transfusion medicine is reevaluating how
it uses blood components. In the past, more transfusion
was better. With dangers now recognized for transfusion of blood components, people are starting to rethink
the cavalier use of blood.
HIV, Hepatitis
Most people think of infectious disease (ID) as the
major danger associated with blood transfusion. In the
past, they were right. Before volunteer donations and
ID testing, more than 10% of blood transfusions were
contaminated with hepatitis and other viruses.
In the early 1980s, HIV came on the scene, which
changed blood ordering habits for a decade. In the
1980s, patients did not want transfusions, and let their
doctors know it. Autologous and directed blood donations flourished as a substitute for allogeneic blood
used in transfusion.
Over the last two decades, lab testing for hepatitis
and HIV has improved greatly, making transmission
of these diseases almost unheard of in the U.S. At the
recent turn of the century, nucleic acid testing (NAT)
was added for HIV and Hepatitis C virus and reduced
the chance of transmission of these agents to miniscule levels. Hepatitis A and B viruses (HAV, HBV) are
rarely transmitted by transfusion as a result of careful
donor history disclosure and extensive testing serum
antigens, antibodies and NAT for HBV.
Other Infectious Diseases
Other infectious diseases are screened for at volunteer donation centers. Examples include West Nile
18 JULY 2010 • advance /Laboratory • www.advanceweb.com
and human T-cell lymphotrophic viruses; these are rare in volunteer blood donor populations and well-screened for by lab
testing. Syphilis is screened with Treponemal-specific tests, but
is not a large threat for transmission and is more of a surrogate
test for risky behavior.
Many microbes not tested for can be transmitted by transfusion. Malaria is usually screened out by careful donor questioning
on travel history, but not totally. The FDA has stepped up surveillance of blood collection agencies, making certain that detailed,
careful histories are taken and evaluated to keep malaria out of
blood components. Bebesiosis microti is a blood parasite found in
the Northeastern region of the U.S. that has caused deaths during
agent transfusion to immunosuppressed patients.
Bacteria, Microbes
The most significant ID danger in transfusion medicine is transmission of bacteria in platelets. Platelet components are kept at
an elevated temperature (22°C), with rotation, in an oxygen permeable bag and with nutrient broth (plasma)—the perfect milieu
for growing bacteria.
Despite careful donor arm preparation and diversion of the first
milliliters of the donation to avoid the skin plug with bacteria, up
to one in 2,000 units are still contaminated with bacteria. Platelets
often go to patients on chemotherapy with lowered immune systems—a potentially lethal combination.
Finally, we don’t know if other microbes can be transmitted by
blood transfusion. In the United Kingdom, five transmissions of
vCJD (Mad Cow Disease) in the blood have likely taken place. This
year, a new potential threat has emerged in the form of xenotrophic
mouse leukemia virus, purported to cause chronic fatigue syndrome,
and which may be in many volunteer donors’ blood.
Other Dangers
The No. 1 cause of morbidity in transfusion medicine is transfusion-related acute lung injury (TRALI) due to antibodies in the
donor’s blood that interact with recipient white cells. This occurs
in the pulmonary vasculature that leads to an adult respiratory
distress syndrome with pulmonary
edema and hypoxia within two to six
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Dr. Tilzer is medical director and
chairman, and Shirley Weber is
director, Department of Pathology
and Lab Medicine, Kansas University Medical Center, Kansas City.
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at the bedside
Defining Analytical
Accuracy
By Anthony O. Okorodudu, PhD, MBA, DABCC, FACB
any healthcare professionals perceive bedside
testing to be less accurate than central laboratory testing. However, reasons for inaccuracies often
relate to unintended clinical purposes, poor compliance
with standard operating protocols and use of devices
that are not comparable to central laboratory instruments in terms of analytical specifications.
Evaluation of bedside testing should focus on the
three phases of the testing cycle: pre-analytical, analytical and post-analytical. And while a review of the
published literature indicates that most inaccuracies in
test results are attributable to pre-analytical processes,
attention has been on the analytical phase. This focus
is in part responsible for regulatory action by the FDA
and other agencies. The FDA has instituted oversight
of review and approval of bedside test devices (Title 21
Code of Federal Regulations–CFR Section 820.3).
FDA-approved bedside test devices must be used
within the scope of intended use and analytical performance specifications. Deviation from the guidelines may
lead to test result inaccuracies and imprecision.
Manufacturer’s Specifications
The intended use specifications can be as simple as
indicating for glucose, for example, that the user “may
use the test strip to test capillary, venous, arterial and
neonatal (including cord) whole blood samples.” Other
intended uses may be more specific regarding adjunct
for disease screening, diagnosis or monitoring of treatment. Thus, a test device for human chorionic gonadotropin (hCG) may indicate “rapid and sensitive immunoassay for the qualitative detection of hCG in serum or
urine. The test is intended for use as an aid in the diagnosis of early pregnancy.” To mitigate the inaccuracy of
test results, the device manufacturer is required to specify other known causes of low or elevated results (e.g.,
Staphylococcus aureus causing false positive results for
Group A Streptococcus test kits or certain intravenous
immunoglobulin therapies resulting in falsely elevated
glucose for some whole blood glucose test devices).
To support the intended use claims, test devices have
analytical performance specifications that are reviewed
and documented by the FDA. The main ­a nalytical
20 JULY 2010 • advance /Laboratory • www.advanceweb.com
f­ eatures specified are precision (i.e., agreement between independent measurements under the same conditions) and accuracy (i.e.,
agreement between measured and true values).
The validation is typically performed in accordance with the
Clinical Laboratory Standards Institute (CLSI) protocols (EP12A2 User Protocol for Evaluation of Qualitative Test Performance;
Approved Guideline-Second Edition and EP05-A2 Evaluation of
Precision Performance of Quantitative Measurement Methods;
Approved Guideline-Second Edition). As an example, Troponin I
(CTnI) on the Abbott Laboratories i-STAT bedside device has precision (CV%) claims of 7.8%, 8.5% and 7.6% at concentrations of
0.53, 2.17 and 31.82, respectively. The corresponding precision data
for a central laboratory CTnI are as follows: 2.6%, 2.2% and 2.9%
at concentrations of 0.297, 5.4 and 62.0 ng/mL, respectively. The
accuracy in terms of method comparison using the same i-STAT
indicates a slope of 0.883 and a correlation coefficient of 0.975 (n
= 189), while the central laboratory analyzer versus comparative
method for CTnI has accuracy claims with slope at 0.979 and correlation coefficient of 0.976 (n = 260).
For some test systems, the accuracy is only defined in terms of
clinical performance of diagnostic sensitivity and specificity. An
example in this case is the hCG for which the Quidel Corp. QuickVue+ One-Step hCG Combo test has a sensitivity of 99%, specificity
of 99% and accuracy of 99%.
These specification claims for bedside devices should be evaluated relative to performance criteria established for each test in
the laboratory. Once the director is satisfied that the performance
characteristics are adequate for patient care testing, the device
should be validated using CLSI recommended protocol to ensure
the claims are upheld in the specific test environment.
Results Responsibility
The laboratory director listed on the CLIA certificate is responsible
for the reliability of the test result and should define the acceptable
accuracy and precision characteristics for each test and ensure that
only devices that meet the established performance claims are evaluated for bedside testing. If the quality of a test result should be independent of testing sites, then all CTnI assays should have a precision
of <10% at the 99th percentile upper reference limit.
Once performance characteristics for all tests are in place,
maximum contributions to the allowable errors in each of the
phases of the testing cycle should be defined. This will provide
guidance for manufacturers in designing devices and give the
FDA reference performance characteristics for approving the
devices. It also will guide institutions in developing operating
protocols for bedside testing. n
Dr. Okorodudu is professor of Pathology and director, Clinical
Chemistry Division and UTMB/CMC Laboratory Services, University of Texas Medical Branch, Galveston.
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automation
automation alert
Safety, Cost
Efficiencies
By Kelly Feist
iagnostic laboratory professionals have an important role to play in ensuring patient safety. The
chance for human errors and omissions is high in specimen collection, testing and blood transfusions because
these processes have so many manual steps.
Automating specimen collection and transfusion
management can create closed loop systems that virtually eliminate errors in labeling of specimens, incorrect
patient draws and incorrect transfusions.
Adding specimen collection management and transfusion management solutions to the laboratory information system (LIS) ensures specimens are collected
from the right patient, for the right tests, at the appropriate time, with the correct indicators, for the accurate
diagnosis. Automation also results in cost efficiencies,
improved quality of care and increased revenue.
Key Patient Safety Challenges
An interview of LIS managers, lab directors and managers, physicians, pathologists and IT support managers at 15 hospitals in the U.S. and Canada resulted in the
identification of four main challenge areas:
• Matching patients and test. The need for positive
patient identification programs is paramount to patient
safety, ensuring the right patient is matched to the right
tests, procedures and products.
When done manually, this process can be time consuming and prone to human error. Patients can become
separated from their wristbands or staff may fail to
properly conduct all steps of a bedside check, resulting
in incorrect or incomplete patient identification.
• Tracking test requests. There are many manual steps
required from test order request to specimen receipt
into the lab and these manual touch-points can lead
to human error.
• Speed versus safety. Reducing turnaround times (TAT)
for labs, emergency departments and other areas of
the hospital while ensuring that the right results are
matched with the right patient and delivered in near
real time is critical, so treatment decisions can be expedited with maximum data.
• Dealing with errors. Lost or mislabeled specimens or
incorrectly administered products or procedures can
22 JULY 2010 • advance /Laboratory • www.advanceweb.com
result in significant follow-up time to determine why the error
occurred and how to prevent it in the future.
Cost Efficiencies
With automatic collection, labels can be printed at the bedside, eliminating traveling. Moving to an automated system allowed a hospital
where phlebotomists were spending 15 minutes per hour on travel
and whose lab techs were spending 10 minutes per hour on specimen
receipt to reduce these times by 60% and 100%, respectively, with an
impact of $415,200 in annual productivity improvements.
An automated system eliminates labeling errors and the associated follow-up time for those errors. For a sample hospital that averages 8-10 labeling errors per month and 1.5 hours average follow-up
time per error, this could be reduced to zero, yielding about $3,400
in annual productivity improvements.
Mislabeled specimens resulting in adverse events can result in
significant financial issues for hospitals, both in terms of increased
insurance premiums and the potential for legal actions brought
against the facility as the result of an adverse event.
Automation can also minimize wasted or unused units of blood.
The start and stop time of each bag of transfused blood is recorded,
as well as where it was administered and by whom, providing confirmation that all units were used and providing the data needed
to determine trends in unused units and make positive practice
changes. In the sample hospital, the automated system avoids the
use of 6-8 units of blood at an average cost of $300 per unit—about
a $28,800 annual cost savings.
Improve Quality of Care
Adverse events resulting from mislabeled specimens can mean
increased hospital stays for the affected patient, additional procedures and treatment and added medications. With an automated
system, the patient bar codes are scanned, the required tests are
confirmed and matched with the order in the system, the specimen
is collected and a label is immediately printed, all at bedside, virtually eliminating the possibility of an adverse event.
The patient bar code and the bar codes on the blood units are
scanned right at the bedside to confirm the blood to be administered
and the patient are a match, virtually eliminating the possibility of
a patient getting the incorrect blood and the chance of an adverse
event occurring. This is important as reimbursement is no longer
provided for care associated with preventable transfusion errors.
Increase Revenues
Automated specimen management also improves turnaround
time, resulting in increased lab and ED capacity, providing
opportunities for additional revenue. n
Kelly Feist is vice president of Marketing, Sunquest Information Systems.
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professional issues
leadership outlook
Evaluation Tools
By Scott Warner
A
s a manager, you may dread annual performance
evaluations. Human resources expert Aubrey C.
Daniels, author of Oops! 13 Management Practices
That Waste Time and Money (and what to do instead),
cites the annual performance evaluation as a destructive management strategy that fails to motivate employees.1 He writes, "The research on performance appraisals has never shown that they improve performance,"
adding, "…the best performance appraisal is one that is
done every day."2 Using a consistent strategy and a few
tools on hand, you can do just that.
CLIA Groundwork
A consistent, objective strategy lays the groundwork
for evaluations independent of your management
style or requirements of your HR department. It's an
approach suggested by CLIA Section 493.1413(b)(8)
The Hawthorne Effect
 In the 1930s, Harvard researchers at a Western Electric
plant in Cicero, IL, discovered that arbitrary measurement
and manipulation of the workplace improved productivity.
This so-called "Hawthorne effect," named after the plant,
demonstrated that social factors greatly influence workplace
norms, productivity and response to management.4 When
employees are observed, their behavior changes.
that describes how the laboratory technical consultant
is responsible for "evaluating the competency of all
testing personnel," using direct observation of test and
instrument maintenance performance, record review,
duplicate and blind sample testing and assessment of
problem solving skills.3
As Daniels notes, measurements allow you to correct or praise behavior soon after it happens, helping
employees succeed. A lab employee's job review should
include objective measurements to ensure procedures
are followed and results are prompt and accurate.
Given the complexity of tasks in a lab—manual and
automated—a variety of approaches must be used.
Performance Indicators
Performance indicators, including peer reports and
benchmarking, are commonly used in quality control,
24 JULY 2010 • advance /Laboratory • www.advanceweb.com
and the same approach can be used to measure behavior on the
bench. A comprehensive approach can be overwhelming. Two
strategies are needed to begin.
First, identify key performance indicators (KPI). Verification of
test performance, for example, can be tracked by direct measurement of quality control and blind samples, number of critical values called per policy, and an assessment of how to handle sample
or analytical errors.
Separate fact from fiction. In this case, "fiction" refers to
judgments made before all data is collected; data collection
needs to be impartial and transparent. For example, if competency in performing instrument maintenance is measured,
a chart documenting direct observation defined by a checklist
can be used. It is crucial that data not be perceived as biased
toward an individual or group, and an open process can be
seen as encouraging employees to help—or compete with—each
other to succeed.
Dashboards
Significant statistical samples will vary among labs. High-volume
testing may require random sampling, for example, while you
may choose to review all cerebrospinal fluid reports and worksheets. Paper log sheets (maintenance logs, etc.), information system database queries and management reports are good sources
of objective data. Once collected, data needs to be presented in a
way that keeps an employee informed of progress.
The performance dashboard can track indicators aligned with
goals and individual performance. A dashboard might contain
a graph of tests performed per hour worked, proficiency testing
performed and number of assessments completed per quarter, for
example. Done on paper or computer, it lets an employee know
what needs to be done; a spreadsheet such as Microsoft Excel can
create this tool.5
What and when to share with your staff are important decisions.
Overall performance can be posted quarterly, for example, while a
monthly report can be given to individuals. While distinguished
from a performance scorecard that evaluates performance against
a metric target or rubric, the dashboard is still useful in highlighting problem areas.
A performance dashboard reviewed with an employee can
gather feedback about your lab. Use it as a template to structure
a conversation about what worked, what didn't and what should
have been done. n
Scott Warner is laboratory manager at Penebscot Valley Hospital
in Lincoln, ME.
 For
a list of references, go to
www.advanceweb.com/labmanager
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26 JULY 2010 • advance /Laboratory • www.advanceweb.com
Will emerging biomarkers
improve risk stratification?
By Mary M. Kimberly, PhD
he National Cholesterol Education Program’s Adult Treatment Panel
III (ATP III)1 and the American Heart Association (AHA)2,3 have each
issued recommendations to identify and manage people’s risk for
developing cardiovascular disease (CVD) and stroke. The risk algorithms include the traditional lipid panel: total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDLC) and low-density lipoprotein
cholesterol (LDLC). However, the ATP III and AHA recommendations do not identify all
people at risk of CVD and stroke.
During recent decades, several emerging biomarkers have been identified as
potentially improving risk stratification. In 2009, the National Academy of Clinical Biochemistry (NACB) issued guidelines on emerging markers (i.e., above and beyond
the traditional lipid profile) to assist the clinical and laboratory community in identifying
patients at increased risk of CVD and stroke.4 In addition, the National Heart, Lung and
Blood Institute has convened ATP IV; this group is expected to release updated recomrecommendations for diagnosis and treatment of CVD.6 Finally, the NACB working group (WG)
reviewed studies that were published through February 2005. This article summarizes the NACB
recommendations and provides updates on subsequently published guidelines.
www.advanceweb.com • advance /Laboratory • JULY 2010
val costanzo
mendations this year.5 Also, in 2009, the Canadian Cardiovascular Society (CCS) updated its
27
cover story
Markers of Inflammation
The NACB WG considered 24 biomarkers of inflammation and made
recommendations for three: C-reactive protein (CRP), fibrinogen and
white blood cell (WBC) count. However, measuring WBC count and
fibrinogen is not recommended for analytical and/or clinical reasons. Using high-sensitivity CRP assays to evaluate risk in primary
prevention was recommended only for people with Framingham
Risk Scores (FRS) greater than 5%.7 The recently completed JUPITER study, which studied people with LDLC less than 70 mg/dL and
CRP less than 2 mg/L, found that lowering CRP reduced CVD and
stroke by 62%.8 The new guidelines from CCS recommend measuring CRP in men older than 50 years and women older than 60 years
with FRS of intermediate risk and whose LDLC has not already identified them for treatment.
Research with other inflammatory markers is ongoing, particularly
for the plasma cytokine interleukin-6 (IL-6)9 and lipoprotein-associated
phospholipase A2 (Lp-PLA2).10 IL-6 appears to be strongly associated
with CVD risk. However, it has high short-term variability and its measurement is neither automated nor standardized.11 A consensus panel
has recommended including Lp-PLA2 measurement as a test for inflammation but did not recommend it as a target for therapy. Currently, one
diagnostic manufacturer provides an assay for Lp-PLA2.
Lipoprotein Subclasses, Particle Concentration
The NACB WG found that although several approaches for measuring
subclasses and one approach for measuring particle concentration
are available, little evidence shows that these approaches provide
clinicians added benefit over standard risk assessment for primary
prevention. Additional issues are a lack of data showing how measuring subclasses over time is useful to evaluate treatment and the
lack of standardization of the various approaches. Standardization
is particularly difficult when method principles are diverse, as is the
case with subclass measurement.
Lipoprotein (a)
The NACB WG did not recommend screening by using lipoprotein (a).
For patients with intermediate risk, the WG left the decision to measure
lipoprotein (a) with the physician and stated that lipoprotein (a) may be
useful in identifying those with a genetic predisposition of CVD.
A recent meta-analysis found continuous, independent and modest
associations of lipoprotein (a) concentration with the risk of both CVD
and stroke.12 These authors found that lipoprotein (a) is a relatively
modest coronary risk factor that may be more important at high concentrations. Measurement issues exist that make standardization difficult. These arise from multiple isoforms and size ­heterogeneity
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28 JULY 2010 • advance /Laboratory • www.advanceweb.com
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cover story
of the lipoprotein (a) molecule. A standardization program is available
for manufacturers and clinical laboratories that provide or use methods that are not sensitive to size polymorphism.13
Apolipoproteins A-I and B
The NACB WG concluded that measuring apolipoprotein (apo) A-I
provides little advantage and did not recommend it. Accumulating
evidence indicates that apo B is a strong predictor of risk for CVD and
stroke but only marginally better than the standard lipid profile. ATP
III recommended non-HDL as a surrogate for apo B because nonHDL and apo B are strongly correlated. NACB also recommended
apo B as a possible alternate to non-HDLC to monitor efficacy of lipid
lowering therapies in patients with elevated TG, but it is not recommended for general screening or to replace LDLC.
A recently published meta-analysis concluded that lipid assessment
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in vascular disease can be simplified by measuring either TC and HDLC
or apolipoproteins A-I and B without the need for fasting or triglyceride
measurement.14 Stable serum reference materials for apolipoproteins
A-I and B are available to achieve common calibration among manufacturers; a standardization program is available for labs.15
Renal Markers
People with chronic kidney disease (CKD) are at increased risk of
CVD. The NACB WG did not recommend testing for CKD ­biomarkers
in people with low risk of developing CVD, though CKD testing is
recommended for primary prevention in people at intermediate risk
for CVD and in people with hypertension, diabetes and family history of CKD. Renal markers of concern are serum creatinine (for
calculation of glomerular filtration rate) and urine albumin. The
National Kidney Disease Education Program has a plan to enable
standardization of these markers.16
Homocysteine
Homocysteine is regarded as a risk factor for CVD, though whether
the relationship is causal is unclear. Screening for homocysteine is
not currently recommended. A reference system has been established for homocysteine measurement.
Natriuretic Peptides
More research is necessary before measuring B-type natriuretic peptide (BNP) or N-terminal proBNP (NT-proBNP) can be recommended
for CVD risk assessment. Laboratorians, clinicians and diagnostic
manufacturers should pay careful attention to preanalytical, analytical and postanalytical issues when these markers are used in patient
care. The International Federation of Clinical Chemistry and Laboratory Medicine has a committee working to improve the quality of
BNP and NT-proBNP testing.
Ongoing Research
Currently, the only biomarkers beyond the traditional lipid panel that
are recommended in primary prevention are CRP and the renal markers. These biomarkers are recommended for people at intermediate
risk based on FRS. Newer analyses have shown the apolipoproteins to
be useful alternatives to TC and HDLC in risk assessment. Research in
other emerging markers continues to evolve, and other markers may
prove useful in the future. In the meantime, the ATP IV recommendations, when available, may change the way risk assessment practice
advances, specifically regarding whether the apolipoproteins will take
a more prominent role in risk assessment. n
Dr. Kimberly is chief of the Lipid Reference Laboratory, Clinical
Chemistry Branch, National Center for Environmental Health,
­Centers for Disease Control and Prevention, Atlanta, GA.
 For
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30 JULY 2010 • advance /Laboratory • www.advanceweb.com
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IMMUNOLOGY
Allergy Testing On the Rise
increasing test turnaround time.
Many methodologies for allergy testing are
available for physicians. Common methods
include skin tests, blood tests (leukocyte histamine release test, the radioallergosorbent
test, etc.) and the elimination test involving
removal of dietary intake.
By Kathy Braniff, MSA, MT(ASCP), Jason A. Kendall, MT(AMT),
and Safedin “Sajo” H. Beqaj, PhD, HCLC, CC(ABB)
As allergy
rates
increase,
clinical
laboratories
have a
unique
diagnostic
opportunity.
llergies and allergen-related disease statistics show an alarming trend over recent decades. Allergic disease is the fifth leading
chronic disease in the U.S. and third among children under 18 years of
age. Asthma rates in children under the age of five have increased more
than 160% from 1980 to 1994.1
Experts speculate on whether global warming, pollution from the
burning of fossil fuels or use of sanitizing agents and antibiotics are
factors that could be impacting the higher rates. The medical community, including clinical testing labs, must rise to the occasion to meet
the demand associated with this trend.
Allergen Testing
Although more laboratories can now offer allergy testing, clinician
requests are still relatively low, making the testing cost prohibitive
for many labs. Patient care will improve as smaller labs add allergen testing to their menu; automated technology holds promise for
32 JULY 2010 • advance /Laboratory • www.advanceweb.com
Blood Test
Blood tests are a favorable method for many
providers. They can be ordered to measure
the amount of IgE to suspected allergens and
are offered in panels of common allergens.
The IgE allergy test 3 carries no risk of
anaphylactic reaction. Additionally, some
patients have skin diseases that can make
the skin test difficult to interpret; others take
medications that would reduce the reaction
for the skin test method, although they often
cannot stop taking the medication without
further risk. The test produces quantitative
and reproducible results and can be used
with all patient populations (pediatric and
obstetric). Disadvantages include a delay in
results of two to three days as laboratory
testing is completed, associated costs and
phlebotomy involved for pediatric patients
(some physicians overcome the latter problem by performing the phlebotomy procedure while the patient is sedated for tympanostomy or other procedures).
scott derby
Skin Test
The skin test is the most widely utilized
allergy test and is usually performed in the
physician’s office. It involves pricking the skin
with a small amount of allergen.
An advantage of this test is that several
allergens can be tested at the same time.
Disadvantages are that result readings can
be affected by medications and are subjective. As well, sensitivity and specificity can
be poor. Additionally, young patients often
fear the skin prick, and the allergic reaction
can be uncomfortable for patients. Positive
results usually cause swelling, redness and
itching at the site. Skin testing also carries
an anaphylaxis reaction risk.2
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IMMUNOLOGY
Elimination
Elimination tests are the least invasive and usually used to evaluate food
allergies. The procedure is completed over several weeks by first removing a dietary substance suspected of causing an allergic response.
Although the test is economical and minimally invasive, disadvantages are the time involved to come to conclusion, only one suspected allergen can be tested at a time
and negative results don’t provide resolution, as the food being tested may not
be a problem.4
Emerging Tests
Component resolved diagnostics increase
test precision by separating traditional
allergen extracts into cross-reactive and
source-specific components while point-of-care analyzers can test for
a specific IgE, use less blood than traditional blood test and are easy
to read visually or with the use of a machine.5
Other future technologies may include microchips, some of which
can analyze more than 150 autoimmunity antigens with a sample the
size of 20 μL 5 and multiplex analysis, depending on the speed and
cost efficiency of the test.
Financial Considerations
Costs for allergen testing have significantly decreased and cost per
allergen test ranges from $3 to $5 per allergen with insurance, depending on laboratory test volumes.6 Reimbursement is also fairly good.
The menu of available allergy testing or allergy-specific IgE testing is
ever increasing. These menus include food, animals, dust mites, molds
and a wide range of seasonal allergies. As the allergen range is broad,
testing is often offered in profiles that include allergens that conveniently screen for a wide variety of allergies and establish the best and
most adaptive treatment for the patient. Profiles may have three specific allergens to 20 varieties. Some of the most popular are:
• food allergy panel, which contains 10-plus varieties of food allergens,
• seafood allergy panel, which contains five of the most common seafood allergens,
• respiratory allergy panel, which contains 20-plus varieties that can
cause respiratory allergies and
• geographic panel to address allergens specific to a particular area of
the country.
Profitability
Building profiles is a convenient way for the clinician and patient
to provide an excellent screening tool, but it is advantageous as
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IMMUNOLOGY
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well for small to mid-size labs. Profile building increases reimbursement and revenue and controls cost by establishing a menu of commonly ordered allergens and ­sending out the more esoteric requests
to a reference laboratory. It can be a
­juggling act for ­laboratory managers to
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they work to provide client satisfaction
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and department cost and waste.
With a common allergen menu and
good marketing materials, allergy testing volume can pick up significantly.
An industry-wide increase in volume
would result in a drop in cost per test,
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Offering allergy testing contributes to
the profitability of the clinical lab by
bringing in revenue and decreasing send-out costs. Since allergy testing platforms are FDA approved, validation and rollout are minimally
problematic and open the door to smaller and mid-size independent
and hospital labs.
Each year, the Asthma and Allergy Foundation of America declares
May to be “National Asthma and Allergy Awareness Month.”7 It is
peak season for asthma and allergy sufferers and a perfect time for
educating people on all that the lab can do to contribute to better
patient outcomes. n
Kathy Braniff is senior laboratory manager at DCL Medical Laboratories, Indianapolis, IN; Jason A. Kendall is a consultant at Clinical
Lab Consulting, LLC, based in Carmel, IN; and Dr. Beqaj is technical
laboratory director at DCL Medical Laboratories.
References
1. The Allergy Solution: Evidence Based Allergy Care for Primary Care Providers. AllergiClinic with Allergy America Universal Serum: The Allergy Solution (2009, March 1). Available at:
http://www.imedicalconcepts.com/home/imedicalconcepts.com/
allergiProgram_files/The%20AllergiSolution.pdf (lass accessed
May 28, 2010).
2. Li JT. Allergy testing. Am Fam Physician 2002;66(4):621-4.
3. Deinhofer K, Sevcik H, Balic N, Harwanegg C, Hiller R,
et al. Microarrayed allergens for IgE profiling methods. 2004
Mar;32(3):249-54.
4. Plebani, P. Clinical value and measurement of specific IgE. Clinical Biochemistry 2003;36; 453–69.
5. Sarratud T, Donnanno S, Terracciano L, et all. Accuracy of a
point-of-care testing device in children with suspected respiratory
allergy. Allergy Asthma Proc 2010;31(2):e11-7.
6. Allergy Testing Cost. 2010 CostHelper.com. Available at: http://
www.costhelper.com/cost/health/allergy-testing.html (last accessed
May 28, 2010).
7. Asthma and Allergy Foundation of America. http://aafa.org/display.cfm?id=10&sub=99&cont=457. Last accessed May 15, 2010.
36 JULY 2010 • advance /Laboratory • www.advanceweb.com
Get the free mobile app at
http:/ / gettag.mobi
CHEMISTRY
eAG and A1c in
Diagnosing Diabetes
The laboratory’s continuing role in detecting
and following diabetic patients is explored.
PG or an oral glucose tolerance test) should
establish the diagnosis of diabetes; and
• A1c of 7% or greater confirmed by a second
A1c- or a PG-specific test (fasting plasma
glucose or oral glucose tolerance test) also
should establish the diagnosis of diabetes.
By David Plaut
iabetes is under-diagnosed,” notes one recent report that reviewed
screening and testing methods.1 About one-third of people with
diabetes do not know they have it, and the average lag between onset
and diagnosis is 7 years.1
Advocating the use of hemoglobin A1c to improve the diagnosis and
reduce the lag time, the authors note:
• A1c does not require patients to be fasting;
• A1c reflects longer-term glycemia than does plasma glucose;
• A1c laboratory methods are now well-standardized and reliable; and
• errors caused by nonglycemic factors affecting A1c such as hemoglobinopathies are infrequent and can be minimized by confirming the
diagnosis of diabetes with a plasma glucose (PG)-specific test.
Their specific recommendations include:
• a fasting PG of 100 mg/dL or greater, a random PG of 130 mg/dL or
greater or an A1c greater than 6.0% as highly suggestive of diabetes;
• A1c of 6.5-6.9% or greater confirmed by a PG-specific test (fasting
38 JULY 2010 • advance /Laboratory • www.advanceweb.com
Clarity Challenges
There have been situations in which the diagnosis of diabetes is not clear from either or
both the A1c and PG values.3 Homa and Maikowska3 proposed that the results should be
“interpreted with caution, as several (confounding) conditions known to influence
these measurement should be taken into
account, as well as use of another diagnostic
method, perhaps with another marker of glycemic control, e.g., fructosamine or 1,5-anhydroglucitol (1,5-AG).”
Assays for fructosamine (FA) have been
available in various forms for more than 20
years but have not sparked much interest
(based on the number of citations in Pubmed).
At least part of this may be due to one of the
early reports on the utility of FA. In this study,
46 outpatients and 25 diabetics had several
measurements of both PG and FA over several
weeks.4 The baseline correlations were better
for FA versus A1c (r = 0.91) than FA versus
scott derby
The Need for Education
One of the reasons more than 30% of diabetics
remain undiagnosed is related to the fact that
many persons, even those with a family history of diabetes, are not screened with either
a PG or an A1c.2 Part of the solution to this
is more education for both the population at
large and heathcare workers. In a survey of an
HMO, 63 respondents reported being diabetic
with fewer than two measurements of their
A1c in the past year.2 Of these 63, nearly 50%
were unaware that the ADA recommended
two A1c tests each year, nearly 40% had not
been informed by their physician of the need
for the test, one-third had never heard of the
test and nearly one-fifth were not seen regularly by their physician.
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CHEMISTRY
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PG (r = 0.75), indicating that all three of the
assays measure different aspects of ­glucose
­control. The high value for FA versus A1c suggests that the two are largely affected by the
same variables (e.g., glucose intake). Six weeks
after discharge, the diabetics showed A1c but
not fructosamine had improved. The authors
concluded that “A1c is a reliable marker of glycemic control while the value of fructosamine
in clinical practice is unclear.”4
The second marker mentioned by Homa
and Maikowska—1,5AG—has also been
studied for more than 20 years. Yamanouchi in 1996 5 followed 28 patients who
were started on (and continuously received)
an oral hypoglycaemic agent for at least six
weeks. Another 28 patients were given such
agents for four weeks, then stopped them
for at least two weeks. All patients were followed for an additional 10 weeks. Serum
1,5AG, fructosamine, A1c and self-monitoring of blood glucose were monitored every
two weeks for 16 additional weeks. The levels of 1,5AG “accurately detected the slight
change in glycemia whereas A1c and fructosamine both failed to detect it.”5
Additionally, fasting PG was less sensitive
than 1,5AG. In patients with A1c about 6.5%
in the preceding 8 weeks, those who showed
a lower concentration of 1,5AG (<10.0 micrograms/mL) had a higher mean daily PG concentration. Results of 1,5AG were correlated
more strongly with the FPG. “Because 1,5AG
accurately detected a slight change in glycemia without delay, it is suitable for use in
monitoring for strict control of glycemia, an
important clinical goal.”5
Recent Reviews
Dworacka stated that 1,5AG “seems to be the
most suitable (compared to FPG and A1c)
parameter for detecting increased glucose
levels. The plasma level of 1,5AG reflects
acute episodes of hyperglycemia more sensitively than A1c and is correlated with FPG
and postprandial hyperglycemic peaks.
The maximal glycemic value observed in a
patient ultimately determines the plasma
1,5AG level. In non-diabetic patients, the
plasma 1,5AG level may serve as a screening marker for postprandial hyperglycemiaassociated cardiovascular risk.” 6
40 JULY 2010 • advance /Laboratory
CHEMISTRY
Similar data have been presented by Dugan.7 “1,5AG is a validated marker of short-term glycemic control. 1,5AG more accurately predicts rapid changes in glycemia than A1c or fructosamine.
It is also more closely associated with glucose fluctuations and
postprandial glucose. Thus, 1,5AG may offer complementary information to A1C.”
Conversion Tables
Most recently, mathematical tables have been offered to convert
A1c values to estimated average glucose (eAG) as a way to overcome
what seems to be confusion in the understanding of the A1c levels. Brick8 randomized a set of diabetics into two groups: A1C and
eAG. Providers discussed the patients' current status and personal
targets for glycemic control using either the term A1C or estimated
average glucose. A follow-up telephone survey was taken 3-4 weeks
later to assess any changes in their knowledge of glycemic control.
The 80 participants who completed follow-up had similar baseline characteristics, including poor understanding of A1C and poor
recall of previous A1C values. At the follow-up, the average scores
for each survey question improved significantly in both groups, with
mean score increasing in the A1C group by 32% and in the eAG
group by 33%. There was no suggestion of a difference in degree of
improvement between groups; eAG was not a more understandable
term or an easier concept for patients to remember.
Recently, Chalew and coworkers 9 examined the agreement
between eAG and mean PG (MPG) from two different populations of type 1 diabetes patients—150 children at a clinic and publicly available data from 1,440 participants in the Diabetes Control and Complications Trial. MPG was derived from the mean of
each patient's self-monitored glucose records over the three months
before the A1c was obtained at the patient's clinic visit. MPG was
calculated from the patient's seven-sample glucose profile during
each quarterly visit. Estimated average glucose was calculated from
each individual's A1c using a previously reported equation of MPG
versus A1c -- eAG = (A1c * 28.7) - 47.7, derived from a continuous
glucose monitoring protocol over a 12-week period.
Their analysis showed frequent and clinically significant disagreement between MPG and eAG. Estimated average glucose
was over- or underestimated MPG by 29 mg/dL or greater (A1c
difference of 1% or greater) in approximately 33% of patients
from both populations. “Frequent discordance between eAG and
MPG in clinical practice will likely be confusing to patients and
clinicians. In patients where eAG overestimates MPG, intensive management based on eAG alone will likely lead to greater
frequency of hypoglycemic episodes. To overcome these limitations of eAG, a customized assessment of A1c with respect to a
patient's MPG should be performed using directly monitored
patient glucose levels over time.”10
This same group more recently concluded
that “disagreement between eAG and MPG
downloaded from patient glucose meters will
cause confusion if eAG is implemented for
clinical use.”11
Detection, Monitoring Methods
Methods are becoming more precise and
standards are available; close agreement for
detecting and monitoring diabetic patients can
be obtained by an A1c measurement. Many
new tests have been added over the years, each
with their own reference interval and perhaps
merit, though none has replaced glucose and
A1c as the preferred tests. The value of other
assays such as FA and 1,5AG await a definitive
study, combined with FPG and post-prandial
PG over an extended period, which includes
outcomes such as neuropathy before replacing
A1c as is or converted to eAG. n
David Plaut is a chemist and statistician in
Plano, TX.
 For
a list of references, go to
www.advanceweb.com/
labmanager
42 JULY 2010 • advance /Laboratory • www.advanceweb.com
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SAFETY
Advancing
Patient
Safety
Patient safety requires a collaborative
effort between man and machine.
By Jill Hoffman
Greater Involvement
James S. Hernandez, MD, assistant professor of Laboratory Medicine
and Pathology, division of Laboratory Medicine, College of Medicine,
Mayo Clinic, Scottsdale, AZ, encourages his lab staff to broaden the
From the moment of specimen collection, barcoding
technology, wristbands and LIS interconnectivity help
keep patients safe.
idea of a lab from a “zone of control” where they focus solely on specimens in their care to a “zone of influence” where they consider the preanalytical realm—in the emergency department (ED), operating room
(OR), clinic, etc.—as well as the post-analytical process.
“We no longer think of ourselves as doing a task, and if it’s out
of sight, out of mind,” Dr. Hernandez says. “We start to think of the
entire system.”
In addition, Dr. Hernandez stresses the need for lab managers
and administrators to create a culture in which it is safe for bench
technologists, in particular, to raise concerns about problems they
observe or are aware of in the lab. He says the emphasis needs
to move from blame for minor slips or lapses to problem solving
(although reckless/dangerous mistakes may require more serious
personnel repercussions).
44 JULY 2010 • advance /Laboratory • www.advanceweb.com
“If a supervisor or manager says, ‘Well,
I’ve had no errors in my area for four years,’ I
would be very suspicious because there’s probably underreporting,” Dr. Hernandez says. “We
have to reverse this so that people feel very free
to bring up all issues of concern.”
Technology
From the moment of specimen collection,
barcoding technology, wristbands and LIS
interconnectivity help keep patients safe.
At UCSF, patients have a wristband bar
coded with their medical record numbers
that helps when, for example, a nurse is
about to perform a glucose test. The nurse
scans the patient’s bar code to verify positive patient identification in the LIS so she
can proceed with collection.
The technology also helps in phlebotomy
at UCSF. A handheld electronic phlebotomy
solution from Cardinal Health called CareFusion interfaces with the LIS so the phlebotomist, after arriving in a patient room with a
pre-entered LIS order, can match information between the patient’s bar code and order
in the handheld device before performing a
draw. The device is attached to a printer so
labels are printed bedside.
Though preprinting labels may seem more
efficient for workflow, the ­practice is
jay wiley
he nature of being human may be the
clinical laboratory’s Achilles heel when
it comes to ensuring patient safety. No matter what technology assists in the steps from
specimen collection to reporting, the accuracy of a result still relies at some point on
the vigilance of an employee to adhere to the
highest possible standards.
“You shoot for zero errors,” says Tim
Hamill, MD, director of Clinical Laboratories, professor and vice chair, Department of
Laboratory Medicine and director, Clinical Laboratories at Parnassus and China Basin Laboratory Medicine, University of California
San Francisco. “And the more robust the process you can make, the
smaller that number gets, but I haven’t seen any process that’s 100%
simply because for any process that you put out there, there’s someone
who will make a workaround and defeat what you’re trying to do.”
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SAFETY
potentially dangerous, says Enrique Terrazas, MD, associate clinical professor, Laboratory Medicine, chief of laboratory information
systems, Department of Pathology and Laboratory Medicine, UCSF.
A nurse who preprints labels may keep them in her pocket and mislabel a requisition. Loose labels at the bedside can cause confusion
and errors if they are not removed before a new patient arrives. Dr.
Terrazas once had a supposedly correct OR specimen sent to the
blood gas lab on a patient who had been discharged days earlier.
Ramifications for mislabeling can be huge.
“If it’s an OR case and [the patient] gets a very low hemoglobin
result, it may lead to an unnecessary transfusion,” Dr. Terrazas says.
“If it’s a glucose value that is very high, it may result in administration of insulin to someone whose glucose value is normal, resulting in hypoglycemia. On the other hand, if the glucose value comes
back normal, and for that patient it’s actually high, it could lead
to not giving the correct insulin dose at that time. For therapeutic
drug monitoring, you could give a wrong dose to try to correct for
a high or low value.”
In addition to assisting the human element of patient identification
verification, bar codes (of patient samples) are read by lab automation equipment to query the LIS and determine what test is needed.
Further out, biometric retinal scanning for patient identification
and radiofrequency identification for specimen tracking may also
help make patients safer.
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Taking Action
A variety of government agencies, national associations and nonprofit organizations have taken up the issue of advancing patient
safety. Everyone from the Joint Commission and College of American
Pathologists to the National Institutes of Health and World Health
Organization provide guidance on the issue. Dr. Hernandez turns
first to the Joint Commission website
when an error is discovered.
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“We have to understand root cause
of patient safety
resources, snap
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about what those tools are and how to
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In addition, a quality committee
involving the Mayo Clinic’s laboratories conducts a root-cause analysis
using graphs, charts and diagrams to
determine what happened and whether
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human error, a lack of resources or
some other factor led to the problem.
“Once we solve a serious error, it improves our system and prevents
other errors from happening,” Dr. Hernandez says.
At UCSF, Dr. Hamill tracks all errors that come to his attention and
compiles the data quarterly. Since the ED has had more mislabeling
errors than other departments, he began collaboratively examining
the department’s processes and asking nurses questions, e.g., where
they obtain labels, if the person who draws the samples also labels
it, etc., to find points of failure.
“It’s a constant process of monitoring, making some kind of intervention, then remonitoring,” he says.
Buck Stop
The question of who is ultimately responsible for patient safety in
the lab produces a range of answers.
The issue is black-and-white for Drs. Terrazas and Hamill. Everyone
involved with a specimen is ultimately responsible for a patient’s safety
from the moment a specimen hits the lab’s doorstep, Dr. Terrazas says.
And while Dr. Hamill agrees that everyone in the lab is accountable
for making lab testing and results as safe for the patient as possible,
he says the person “ultimately responsible” is the name on the federal
CLIA certificate—and in the state of California, the name on the state
license, i.e., the medical director for the laboratory. He says this is akin
to saying President Obama is ultimately responsible for everything that
happens in the U.S. government.
For Dr. Hernandez, the matter is less definitive. He says, “I laugh and
say that as laboratory medical director I’m the sheriff, but I deputize
everybody in the laboratory to help me. Ultimately, if there’s an unsafe
environment in a laboratory, the buck stops with me. That’s pretty clear
from the Joint Commission and College of American Pathologists and
CMS, but at the same time, I can’t do this by myself. I need to make sure
that everybody is aware of safety and does their particular part.” n
Jill Hoffman is a senior associate editor.
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BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. © 2010 BD VS8866
OUTREACH
Surviving the
‘Connected
Healthcare Tsunami’
Configurations,
Considerations of
Outreach
By Lynn Nace
How to
maximize
your
laboratory’s
potential for
outreach
testing.
he notion that a laboratory’s performance will be measured only
by its productivity and accuracy has given way to a new standard: profitability. A restricted economy, a shift in the paradigm of
hospital management to integrated healthcare systems and recent
healthcare legislation have placed a new onus on laboratories to perform more as a business.
Automated laboratories perhaps run at an advantage in this regard.
Through automation, a laboratory can manipulate workflow and staffing levels, creating the capacity to take on more work from sources
outside the hospital they serve, such as surrounding doctor’s offices
and smaller, less-equipped hospitals.
While the elements of what makes a successful outreach program
remain the same as was reported in a 2008 "Automation Alert" column in ADVANCE for Administrators of the Laboratory by Beckman’s
Ronald Berman, “Automation and Outreach Testing: Critical Factors
for Outreach Success,” automation technologies have changed to the
benefit of medium- to high-throughput laboratories.
Newer Configurations
New automation configurations have been developed to meet
every level of throughput, so that efficiencies and capacity are­
48 JULY 2010 • advance /Laboratory • www.advanceweb.com
he American Recovery and Reinvestment Act (ARRA) “meaningful use” requirement is creating an enormous demand
for interoperability, resulting in a “connected
healthcare tsunami.” With more than 70%
of all diagnostic decisions derived from
laboratory data, the connection between
the lab and the EMR/EHR is critical. Laboratories are about to experience a dramatic
increase in order volume from systems they
do not control; EMRs will need to keep up
with the demand to connect physician offices with a myriad of laboratories.
Connected healthcare is a reality, requiring labs and EMR vendors to identify
and quickly implement new strategic connectivity plans before it’s too late.
When looking for an integration solution,
be sure it’s scalable and designed to efficiently manage these new demands. Sophisticated interoperability is a must. As
well, the ability to connect the lab to an
EMR system by providing orchestrated
workflow and intelligent network and data
management also is key. An integrated
system should support seamless integration to ensure clean electronic orders from
any EMR system. Multi-staged workflow
support allows the order to originate in
the EMR and get cleaned up in the physician office, at the patient service center
or in customer service. This increases the
lab’s ROI and enables the lab to remain in
control while implementing and proactively
managing the data from physician EMRs
across its network. The challenges of ARRA and “meaningful use” also present opportunities. Lab
managers, for example, may consider a
platform’s support for CPOE for anatomic
pathology, radiology and ePrescribing as
the core for their “meaningful use” strategy
in addition to lab order entry. As the traditional lab IT paradigm evolves, it forces labs
to deal with systems they cannot directly
control. Be sure to consider a solution designed to ensure you can still get the right
order, deliver the right result and get paid
for what you do. n
Rob Atlas is CEO and president of Atlas Medical (a division of Atlas Development Corp.).
Jeffrey Leeser
Jeffrey Leeser
By Rob Atlas
Keep your lab competitve.
Harvest the power of EMR
connectivity with Orchard Copia.
Help Your Clients meet Meaningful Use Criteria
With the government’s $20 million ARRA/HITECH
stimulus in place for the adoption of EMR/EHR technologies, the race is on for interoperability. Of the stage
one meaningful use criteria, a few revolve around lab
orders and results, and more and more provider practices
are asking for electronic integration between their EMR and
their hospital and/or reference laboratory.
Stay Competitive with EMR Connectivity
Designed to work as an add-on to
your existing lab system or with
Orchard’s laboratory and pathology systems, Orchard’s front-end
outreach and EMR integration
system—Orchard® Copia®—makes your lab more competitive
by enhancing connectivity with your lab clients via the Internet or
directly to their EMR.
Enhance Access and Expand Your Outreach
Client/EMR
Client/EMR
Web Portal
for Outreach
ORDERS &
RESULTS
ORDERS &
RESULTS
ORDERS &
RESULTS
For clients looking to meet meaningful use criteria, Copia
interfaces directly to their EMR, allowing them to electronically receive patient demographics and lab orders and then send
results back. For those clients still without an EMR, Copia
provides remote access via a web portal to place orders; edit
patients’ demographics; print labels, requisitions, and invoices;
and view completed results.
RESULTS
RESULTS
ORDERS
ORDERS
Reference Lab
DFT
Billing System
or Legacy LIS
Stay competitive and help your clients meet their meaningful use criteria.
Call Orchard for a demonstration of how Orchard connects you to your clients’ EMRs.
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www.orchardsoft.com
© 2010 Orchard Software Corporation
OUTREACH
achievable without the necessity of a full automation line.
The recent introduction of integrated systems that pair chemistry
and immunoassay testing on one platform speed workflow by greatly
reducing certain time-consuming manual tasks such as decapping and
capping. Additionally, trackless integrated systems have the capacity
to process samples in parallel, saving time and speeding results.
Modular integrated systems make it possible for a laboratory
to configure a work cell to meet their testing needs and allow for
more capacity for chemistry or immunoassay testing according to
patient population.
Automated pre- and post-analytical systems, also new to the market in recent years, automate the most manual and time-consuming
tasks performed prior to analysis–sorting, centrifuging, alliquotting,
etc. When paired with an integrated system, a laboratory without the
resources to install a full automation line can still achieve measurable efficiencies and increased capacity in a footprint smaller than
a full automation line.
Considerations
Scott Lavine, marketing director of Antek Healthware, says “Transitioning your organization from a physician office laboratory (POL) or
hospital lab to a reference lab is a major undertaking for any laboratory.” At first glance, this may seem to be a natural progression for
your lab, “but you should carefully consider the challenges to outreach before moving forward.” A good starting point is to research
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the additional requirements needed to comply with state and federal regulations. Lavine recommends considering other points as
well, including:
• staffing, scheduling and insuring the couriers;
• leasing a fleet of vehicles;
• careful stocking and tracking of blood draw supplies;
• hiring additional medical technologists and phlebotomists;
• the need for a second or third shift;
• ability of current analyzers to support the increased volume;
• renegotiating reagent rental contracts based on a new volume; and
• marketing and selling your services
Automating Ordering and Result Delivery
Says Lavine, “A key to service is simplifying the process of creating requisitions or test orders for clinicians and their support staff.” You may
want to consider automating this with
remote ordering, he adds, which allows
 For strategies of
the physician to order directly into the
an integrated solution,
LIS software at your lab. It also avoids
snap this bar code
on your smartphone.
duplicate manual entry, which in turn,
reduces clerical errors and allows staff
to focus on more important tasks.
In addition, this process will automate the printing of completed requisitions and labels for the tubes and
Get the free mobile app at
generate a manifest of all patients
http:/ / gettag.mobi
ordered. When your lab completes
testing, the results will be available
for remote viewing and/or printing at your clients’ locations.
“By ordering directly into the LIS, the practice can utilize specialized ordering rules like automatically printing an Advanced Beneficiary Notice and checking CPT and ICD-9 validation to ensure timely
payment for the insurance company,” notes Lavine.
Another benefit is the setup of standing orders. This allows the
practice to ensure patients are scheduled for routine testing (such as
Pro Time or Glucose) at predetermined date/time intervals.
A New Role
For outreach to be achieved, however, the lab director must have the
capacity to perform as a business person, not just a clinician, fighting
for the resources necessary to make the initiative a success. Though
automation is a key component, proper infrastructure also is crucial.
It’s critical to follow through for billing, have an optimal sales force
and have buy-in from hospital management so a long-term business
plan can be developed and achieved.
Ultimately, the bottom line for success is to identify client service
offerings that will differentiate you from your competition. This will
depend on your ability to offer superior value over competitors and
expertise in outreach sales and marketing. n
Lynn Nace is editor of ADVANCE for Administrators of the Laboratory.
EOE/ADA
50 JULY 2010 • advance /Laboratory • www.advanceweb.com
HEMATOLOGY
Cellular Analysis
Improvements obtained from digital
morphology are explored.
A Staff Report
hen it comes to cellular morphology, manual analysis is only as
consistent as the laboratory’s best morphologist. So, as skilled
morphologists dissipate into lab generalists, so does consistency and
accuracy. Consequently, many laboratories are turning to automated
digital morphology.
Traditional cell morphology analysis is a
demanding, manual process involving the
visual observation of cells on a stained blood
film. In most labs, this type of analysis is performed by a morphologist using a microscope.
The technician compares the shape, size and
Automating the handling of
manual differentials raises the
level of quality and consistency
of analysis.
color of the cells in the sample with standard
cells and categorizes them. While widely used,
this traditional method of cell morphology
analysis is time consuming and fraught with
inconsistencies. Depending on the skill level
of the morphologists, results can have a high
level of variability, as each morphologist may
interpret the morphological detail differently
and produce different results.
Digital Cell Morphology
However, advances in information technology
have facilitated the development of digital cell
morphology, a more efficient and streamlined
way of handling manual differentials. With
digital cellular ­morphology, technicians
Automated cellular analysis may be performed
on sophisticated hematology analyzers. Depicted
above are the CellaVision Body Fluid Application
and DM1200.
52 JULY 2010 • advance /Laboratory • www.advanceweb.com
cellavision / beckman coulter
Efficiencies of
Bio-Rad Laboratories
QUALITY CONTROL
A Perfect View. Perfected.
Bio-Rad introduces a full line of new Hematology Controls to
the products and services you’ve already come to love.
Liquichek™ Hematology Controls
• For use on over 35 hematology analyzers
• 3- and 5-part differentials
• Multi-level controls
The Liquichek™ Hematology and Reticulocyte
Controls line from Bio-Rad has expanded greatly,
offering a total of 12 controls for use on all
major hematology instruments, such as Abbott,
Beckman Coulter®, Siemens, Sysmex and more.
Peer group values available through
Unity™ Interlaboratory Program at
www.QCNet.com
You already know that there’s more to Bio-Rad
than just controls. Bio-Rad has a 92%
satisfaction rating* for customer service, powerful
QC Data Management tools for peer reporting,
and 300 plus quality controls.
For more information, contact your local Bio-Rad office
|
US: 1-800-2-BIORAD
|
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|
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*Based on an average from customer satisfaction surveys for customers who received service from Bio-Rad, Quality Systems Division, during January - March of 2010.
Visit us at our AACC Booth #7200
HEMATOLOGY
can now automatically analyze the morphology of a cell and flag samples
based on their morphologic features and abnormalities. In ­addition, a
laboratory can gain the ability to share cellular images and data with
labs in multiple locations, but store cell images and ­differential results
in comprehensive databases in a centralized location.
An even greater level of quality occurs by taking the digital flow
cytometry output from an automated hematology system and managing manual differentials with an automated digital morphology analyzer. For example, one of the newest hematology analyzers available
to laboratories, through high-definition signal processing and multiangle light scatter, can produce as
much as 10 times more data than
traditional hematology analyzers.
When coupled with digital cell
morphology analysis, the resulting data can make a substantial
difference in the patient’s care.
In fact, some industry experts
Automated cellular analysis may be performed on
Beckman Coulter's UniCell DxH800.
3320
SingleSample
20 µL
3250
SingleSample
200 µL
say that over the last 10 years or so, clin For industry
ical laboratorians have been running
news on digital
tests that flag only significant increases
morph­ology, snap the
following bar code on
or decreases in number and types
your smartphone.
of specific cells, and haven’t had the
high-definition data to review slight
changes in cell morphology. It’s these
slight changes that may be an early
indicator of serious disease. With digital cell morphology, labs can put flags in
Get the free mobile app at
the system to detect subtle cell changes
http:/ / gettag.mobi
automatically and share digital images
of the cells across the hospital system for further analysis.
Quality Improvement
Apart from the benefits derived from automating a manual process—
streamlined work flow, resources and efficiencies—automating the
handling of manual differentials through digital cellular morphology raises the level of quality and consistency of analysis in even the
most challenging laboratories. n
Information compiled by ADVANCE staff.
2020
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20 µL
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54 JULY 2010 • advance /Laboratory • www.advanceweb.com
781.320.9000
Small enough to
fit on your desk.
Large enough to
transform your lab.
Introducing the UniCel DxH 800
Coulter Cellular Analysis System.
The UniCel DxH 800 is designed to be your next step toward
greater productivity. Unparalleled, high-quality results
are assured by a host of new and proprietary technologies
including High Definition Cellular
Analysis and Flow Cytometric
Digital Morphology. However,
Now distributed by Beckman Coulter**
this is only the beginning.
Innovative efficiency tools enable the UniCel DxH 800
to provide one of the leanest platforms in the industry. In only
a small desktop footprint, the DxH 800 produces 10 times
more data on each cell than traditional hematology systems.
Chemistry
Disease Management
And while it may be small
in size, the UniCel DxH 800
offers revolutionary
scalability* to meet
precisely your laboratory’s
present and future needs.
To learn how the UniCel
Magnetic transport system delivers auto
DxH 800 can transform
repeat and “load ’n’ go” capability.
your laboratory for a new
era of cellular analysis, contact your Beckman Coulter
representative or visit us at beckmancoulter.com/DxH.
Immunodiagnostics Centrifugation Molecular Diagnostics
Hematology
Hemostasis Information Systems Lab Automation Flow Cytometry Primary Care
© Copyright 2010 Beckman Coulter, Inc. Beckman Coulter, the stylized logo, Coulter and UniCel are registered trademarks of Beckman Coulter, Inc.
DxH is a trademark of Beckman Coulter, Inc.
*Connectivity under development. For Investigational Use Only. Not for use in diagnostic procedures.
** Closing the loop from analysis to slide review, Beckman Coulter now distributes CellaVision products that can digitize pre-classified cell images
for review on a PC based workstation. Products may not be available in all markets. CellaVision is a registered trademark of CellaVision AB.
CELLAVISION DM1200
®
—with the smaller lab in mind
CellaVision DM96
CellaVision Remote
Review Software
CellaVision DM1200
Things will change in your hematology lab
• Reduced review time for differentials
• Continuous improvement of morphology skills
• Real-time connectivity to multiple sites
Over 200 labs throughout North America have already
discovered how CellaVision can help improve the efficiency,
consistency and connectivity of the manual differential. The
CellaVision DM1200 can share a database with other DM
analyzers throughout a Health Network. CellaVision Remote
Review Software allows hospitals the ability to share staff, no
matter where they may be located.
Free Cell
aVision
Compete
ncy Soft
ware at A
ACC
booth #4
444
CellaVision North America • 800-390-1374 • na.info@cellavision.com
US • CellaVision Inc. • 800-390-1374 • us.info@cellavision.com
Canada • CellaVision Canada Inc. • 800-390-1374 • ca.info@cellavision.com
CELLAVISION® DM1200
Quality Assurance
Validation, Verification of
Method Comparison
Quality management and the role of performance standards are explored.
By Carol R. Lee, MS, and David G. Rhoads, PhD
Editor’s
note:
This is the
first of a
3-part series.
ctivities needed to manage and implement the quality processes specific to
the validation and verifications of method
performance in the clinical laboratory are
crucial concepts. In this first of a three-part
series, we focus on the role of performance
standards for clinical laboratory tests.
Quality Management: Not Just QC
Most laboratorians initially started with the
task of tracking quality control (QC) functions, running the necessary controls and
manually filling in hard copy Levey-Jennings process control charts with big, black
markers. In recent years, total quality management (TQM) has expanded to include
quality assurance (QA) functions designed
to define, refine and automate the entire process from receipt of the requisition to the
production and delivery of test results and
beyond. Depending on the certifications needed to operate a specific
lab, regulations intended to ensure the quality of test results include
CLIA ’88, with additional “enhanced” requirements by deemed proficiency testing providers such as CAP, New York State and numerous
state health organizations, as well as inspection agencies like The
Joint Commission or COLA. Table 1 lists the QA activities required
on a one-time basis or on a regular basis.
Setting performance standards for the
acceptable performance of clinical laboratory tests on a day-to-day basis is a key component of the QA function. When ­discussing
­performance standards or performance goals,
it is in reference to the total error allowed for a
single replicate measurement of a patient
Table 1: Regulatory Requirements for Quality Assurance Experiments
CLIA '88
Accuracy
✓
tom whalen
Linearity
CAP
✓
JCAHO
✓
✓
CLIA '88
Method Comparison
Sensitivity
✓*
✓*
CAP
JCAHO
✓
✓
✓
✓*
Reportable Ranges
✓
✓
✓
Specificity
Precision
✓
✓
✓
Carryover
✓
Reference Intervals
✓
✓
✓
INR – Geometric Mean
✓
✓*
✓ Required by regulatory legislation or organization. ✓* Required only if test is modified from original form or is “home brew”
www.advanceweb.com • advance /Laboratory • JULY 2010
57
Quality Assurance
Table 2: Nationally Established Criteria for Total Error
Analyte
Guideline
Cholesterol
8.9% 1
HDL Cholesterol
13%1
LDL Cholesterol
12%1
Triglycerides
15%1
Creatinine
7.6% 2
HbA1c
6%3
1. National Cholesterol Education Program, Recommendations on Lipoprotein Mea­
surement by the Working Group on Lipoprotein Measurement. (September, 1995)
NIH pub: 95-3044.
2. Myers, et al. (2006) Recommendations for Improving Serum Creatinine Mea­
surement: A Report of the Laboratory Working Group of the National Kidney
Disease Education Program. CCJ 52, 5.
3. NGSP (2009) http://www.ngsp.org/ CAP Survey limits to be lowered to 6% in 2011.
specimen as compared to a “true” value. The definition of total allowable error (TEa) as an indicator for medical usefulness dates back at
least 30 years, is specified in many of the current regulations, and is
now in widespread use. Because a single point is measured, it includes
the elements of both imprecision and bias from the true value (e.g.,
accuracy) also referred to as TEa around the “true value.”
Total error includes two components: The first is allowable random
error (REa) as a measure of imprecision; and second, allowable systematic error (SEa) or bias, a measure of accuracy as the deviation from
the true value. These two metrics define the two key values on which
the quality of our primary product, patient results, is based. REa can
assist in targeting the SD to be used in daily QC.
After the TEa is agreed upon, SEa and REa can be budgeted into
the whole. Defining the budget for accuracy (SEa) as a percent of TEa
turns out to be very dependent on being able to use standard materials
that are traceable to a true value or reference value applicable to the
method in question. If the bias is significant, the REa budget needs to
shrink to maintain the same error rate.
A model that fits well for most clinical labs follows a three standard
deviation (SD) model, equivalent to an error rate of 1,350 errors per
million (epm) and aligning with the CLIA recommendation of ±3 SD
for analytes without specific numerical guidelines. In this model, TEa
= SEa + 3 x REa. TEa will be the first metric to be defined.
How Are Values for Established Tests Defined?
There’s no single allowable error that is perfect for all methods. The
object is to use values that are “just right.” Total error should be small
enough be defensible and clinically responsible, minimizing the probability of releasing inaccurate results. The appropriate TEa should also
58 JULY 2010 • advance /Laboratory • www.advanceweb.com
be large enough to be attainable and analytically achievable without
accruing excessive costs to keep the process in control.
Where Do Performance Standards Come From?
Most of the time, TEa is either predetermined by the applicable regulations or by derivation using available data. The first thing to consider
is whether an analyte has universally recognized medical requirements, which only a small number of analytes do. TEa for Total Cholesterol, HDL Cholesterol, Triglyceride, LDL Cholesterol, Creatinine
and HbA1c has been standardized and should be used. Otherwise,
the values from regulatory sources such as CLIA or CAP should be
used. CLIA '88 includes TEa criteria for about 75 ­analytes. Most are
expressed in terms of ± concentration units, percentages or both.
Some are expressed in terms of the achievable SD distribution in a
proficiency survey (e.g., TSH is specified as ± 3 SD).
Values provided in the CLIA regulation are, by definition,
Table 3: Examples of CLIA Guidelines for Total Error
Analyte
Guideline
Glucose
±6 mg/dL or ±10%, whichever is greater
Sodium
±4 mmol/L
TSH
± 3 SD
Table 4: Recommendation for
Calculating Allowable Error Estimate
Step
Process
1
Collect the mean and SD from six to 10
proficiency test (PT) specimens at various levels
and encompassing more than one survey event.
2
Convert the SDs to CVs.
3
Calculate the median CV and multiply by 3, which
represents 3 SDs.
4
Round up or down gently to a whole number. This
will be the % component.
5
If you need a concentration component for analytes
with clinical significance at low values, use either
the stated or calculated SD of a low-level control or
patient pool multiplied by 3.
6
This will provide you with an allowable error
estimate (TEa) that might be expressed thusly
for glucose: The TEa is “±6 mg/dL or ±10%,”
whichever is greater at the level you are evaluating.
7
In EP Evaluator™, the Performance Standards
module will perform the calculations and provide a
report convenient for regulatory compliance.
The industry standard in Quality Assurance Software
for the Clinical Laboratory
SIX MAJOR ADDITIONS:
Data Extraction
Simple Accuracy
CLSI EP6 Linearity
Histograms and Descriptive Statistics
Stability
Competency Assessment
EP Evaluator provides the statistical tools needed to validate and evaluate
your clinical laboratory methods. Produces clear, concise, inspector-ready reports
to meet all CLIA ’88 and CAP method evaluation requirements. EP Evaluator Release 9
includes 32 modules and enhanced options for data acquisition, providing the
assurance you demand and the simplicity you desire.
To learn more call (800) 786-2622 (US & Canada) or download a Free Trial Version at
www.datainnovations.com/ee
EP Evaluator incorporates copyrighted Standards and Guidelines of the Clinical and Laboratory Standards Institute.
EP Evaluator
Š
Quality Assurance . . . Simplified
Quality Assurance
the largest one would want to specify. Technology in 2010 is much
improved since CLIA was first enacted; for many analytes on modern
automated instruments, responsible labs can pare the value down to
an achievable smaller value without affecting the costs to maintain
the process.
When there is no pre-defined or mandated TEa value for a particular
test, it is possible to derive one using data that is readily available from
a peer group proficiency survey. This is relatively straightforward for
established tests or those already approved or cleared by the FDA. You
can also use performance data from peer group surveys and it is recommended that you review the data for your instrument’s specific peer
group. A generalized recommendation for calculating an allowable error
estimate using peer group data is outlined in Table 4.
Why a Concentration Component?
For many analytes, a TEa expressed as percent will not work at concentrations near the lower limit of the reportable range. The analytical
sensitivity of the method may dictate that below a certain value, the
SD will remain fairly constant. For example, in an experiment to verify
reportable range and accuracy for LDH, the TEa is 20%. Suppose the
assigned value of a low standard is 5 units, and the mean measured
value is 7 units (40% above the defined value). While the difference
is clinically insignificant, the test for accuracy fails. A concentration
component should be defined for TEa in addition to the percentage to
prevent setting unrealistic expectations at the low end.
There are several ways to obtain a usable value for the TEa at the
low end. The manufacturer may offer a low-end precision SD, or the
SD obtained from a low concentration sample in a peer group PT survey or monthly QC survey could be used. A good source would be the
observed low-end total precision SD from the CLSI-EP5 complex precision experiment. In all cases, multiply the SD by 3.
Therefore, for most analytes, it is desirable to use concentration at
the low end and percentage at the high end. This is expressed as “x
units or Y%, whichever is greater.” There is a crossover point at which
the concentration will equal the percent. Using a percentage target at
these low levels often gives an unachievable value. The Figure shows
a typical test’s error profile expressed in CV and SD.
Figure: Typical Error Profile
Error Profile
30
25
25
CV
20
SD
30
SD
20
crossover
point
15
15
10
10
5
5
0
Table 5: Performance Standards Usage by EP Evaluator™
Usage by Module
TEa
REa
Simple Precision
Optional
Optional
Complex Precision
Optional
Optional
Alternate Method
Comparison
Optional
CLSI EP-9 Method
Comparison
Required
Two Instrument
Comparison
Required
Multiple Instrument
Comparison
Required
CLSI EP-10
Required
Linearity
Required
Required
Accuracy
Required
Required
Calibration
Verification
Required
Required
Reportable Range
Required
Required
Precision in
Linearity Module
Required
Required
SEa
Required
Required
How Are Performance Standards Applied to the QA Process?
Depending on the specific experiment being run, pass/fail criteria
may rely on one or more of the components of the total error. Some
experiments such as two instrument comparisons or multiple instrument comparisons base the pass/fail criteria on whether observed data
points lie within total error limits compared to the “true” value. Experiments that assess accuracy or calibration verification require comparison to the systematic error to pinpoint the method’s observed bias for
acceptance. Modules assessing imprecision will use the allowable random error budget as the acceptance goal. Table 5 lists those modules in
EP Evaluator™ that use performance standards as the primary indicator of the pass/fail criteria, and shows whether it uses systematic error
and/or random error in addition to total allowable error.
The use of performance standards TEa, SEa and REa is fundamental to the method evaluation phase of laboratory quality assurance. The key is to obtain and use TEa that is both attainable (performance goals are achievable on the method in question) and
defensible (the goals are clinically responsible with no greater error
rate than is acceptable). n
0
0
200
400
600
Concentration
60 JULY 2010 • advance /Laboratory • www.advanceweb.com
800
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and developed EP Evaluator® and is the director of Rhoads, a brand
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VITAMIN D
By Kelly J. Graham
The list of
benefits
of this
impressive
nutrient
continues
to grow.
t seems too good to be true that one vitamin might slow or prevent the development of cancer, promote healthy newborns, keep
our bones healthy, strengthen cardiovascular function, keep the
immune system running properly,
defend against infections, promote
mental health and help keep pain levels in check. But vitamin D has been
associated with all of these benefits
and has received much attention in
recent years. Clinical laboratorians
have become intimately familiar
with the importance of vitamin D, as
testing for 25-hydroxyvitamin D, or
25(OH)D, has seen a massive uptick
in recent years.
The Test
Testing for 25(OH)D is typically performed to determine if a vitamin D
deficiency is causing bone weakness
or malformation or is affecting metabolism of calcium. This is a long-term
measurement that looks at the total
amount of vitamin D circulating from
both sun exposure and diet.
In the U.S., we get most of our vitamin D through exposure to sunlight
and dietary supplementation—both
sources are then converted by the liver
to 25(OH)D. Low levels of 25(OH)D
suggest that an individual is not getting enough exposure or dietary intake
or there is a problem with the intestine’s absorption of vitamin D.
Although 25(OH)D is the major
form of vitamin D that is measured in
the blood, 1,25-dihydroxyvitamin D,
or 1,25(OH)(2)D, might be ordered if
the patient’s calcium levels are high or
the patient has lymphoma or sarcoidosis. This is the active form of vitamin D, which binds to vitamin D receptors (VDRs) and produces
proteins important for cell life cycles. Low levels of 1,25(OH)(2)D are
seen in kidney disease and can alert laboratorians and physicians
to early kidney failure. High levels of 1,25(OH)(2)D may be present
when there is excess parathyroid hormone or when sarcoidosis or
62 JULY 2010 • advance /Laboratory • www.advanceweb.com
Associated Illnesses
The most common conditions associated
with insufficient vitamin D levels are bone
issues—weak or deformed bones, rickets
in children, osteomalacia or osteoporosis
in adults. But the list of possibly associated
diseases and conditions is much longer and
includes heart failure, stroke, hypertension,
multiple sclerosis, autism, cancer, Type 2
diabetes, systemic lupus erythmatosus and
other instances of autoimmunity.2
tom whalen
Value of Vitamin D
some lymphomas are making 1,25(OH)(2)D
outside of the kidneys.1
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VITAMIN D
Cardiovascular problems, particularly hypertension and coronary Laboratory Uncertainty
heart disease, occur at higher rates with increased distance from the The recent attention on vitamin D levels has brought to light chalequator. Prevalence of vitamin D deficiency also increases the farther lenges in determining both optimum supplementation levels and
away one lives from the equator. Vitamin D affects many tissues and ideal levels of 25(OH)D in the blood. Traditionally, levels as low as 8
ng/mL were accepted as the minimum recommended
systems critical to cardiovascular health, suggesting its
level, but that lower level may be as high as 32 ng/
critical role in heart health.
 Snap this tag to
hear an audio clip
mL, with 50-80 ng/mL considered optimal. Dr. HolAutoimmune diseases also are more prevalent farther
about the increase
lis calls 50-70 ng/mL optimal, but says individuals
from the equator. Vitamin D has been shown to influence
in vitamin D testing
won’t get anywhere near that just taking the lowest
dendritic cell function; it is these cells that either direct
over recent years.
official recommendation of 200 IU/d.
the immune system to tolerate or attack a particular cell
To reach those optimal levels in the blood, Dr. Holor protein, which may explain the link between vitamin
lis says, an infant would need to be receiving around
D deficiency and autoimmune diseases.
400-700 IU/d with that number increasing into the
Bruce W. Hollis, PhD, professor of Pediatrics and
several thousands the more body mass a person has.
Biochemistry and Molecular Biology and director of
Get the free mobile app at
These levels, he clarifies, would allow a person to
Pediatric Nutritional Sciences at the Medical Univerhttp:/ / gettag.mobi
attain the maximum benefits from vitamin D—mussity of South Carolina in Charleston, explains that a
culoskeletal health, cardiovascular benefits, stronger
focus of several recent studies involving vitamin D
have looked at nutritional status and the ability to ward off infec- immune system and overall health benefits. However, when setting
tions. A randomized, controlled trial3 out of Japan, for example, sup- the recommended intake, organizations look only at the amount
plemented school children with 1,200 IU/d of vitamin D; the results needed to protect against bone health; they are not considered the
suggested that supplementation during the winter may reduce inci- other benefits of the nutrient.
This is unfortunate, Dr. Hollis notes, because there have been
dence of seasonal influenza.
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64 JULY 2010 • advance /Laboratory • www.advanceweb.com
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VITAMIN D
no adverse effects found with increased vitamin D supplementation and the epidemiological and observational data suggest only
positive results.
“The best outcomes were from the group that took 4,000 IU/d,
and we saw not a single adverse event due to vitamin D intake,” Dr.
Hollis explains.
Vitamin D and Fetal Health
Vitamin D has long been considered a critical nutrient for pregnant
women due to its importance in proper skeletal formation, but it
is now known to play an even more important role in nurturing a
healthy fetus.
The current recommended amount is 200 IU/d, but if a pregnant
woman receives only that amount, she and the fetus will both be
deficient compared to the desired 32 ng/ML circulating 25(OH)D
level.4 The correct amount is probably closer to 2,000-4,000 IU/d
for a pregnant woman, and even more for a lactating woman (precise
amounts vary based on skin color, sunlight exposure, sunscreen use,
latitude, etc.). In fact, three recent studies in which Dr. Hollis was
involved—currently being prepared for publication but presented at
the May Pediatric Academic Society meeting in Vancouver—showed
that pregnant women who were supplemented with higher levels of
vitamin D had less incidence of bacterial infections, less pre-term
labor, and less complications of pregnancy (pre-eclampsia, diabetes
and hypertension).
A Critical Role
Because of the plethora of conditions associated with vitamin D deficiency and the uncertainty over optimal 25(OH)D levels, the clinical
lab must be aware of the value of vitamin D testing far beyond its traditional uses in assessing bone health and calcium absorption. n
Kelly J. Graham is associate editor.
References
1. Vitamin D. Lab Tests Online®. Accessed at www.labtestsonline.org
2. Blocki F. Vitamin D deficiency. ADVANCE for Administrators of
the Laboratory 2009;18(2):36-41.
3. Urashima M, et al. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr
2010;91:1255-1260.
4. Hollis BW. Circulating 25(OH)D levels indicative of vitamin D
sufficiency: Implications for establishing a new effective dietary intake
recommendation for vitamin D. J Nutr 2005;135:317-322.
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Next-Gen
Prenatal Testing
By Luis LaSalvia, MD, MBA
An
integrated
approach
focuses on
maternal
and fetal
well-being.
n exciting new approach has emerged in the delivery of prenatal
care; the clinical laboratory is playing an important role. In this
promising integrated diagnostics model, biomarkers, maternal data
and imaging modalities such as ultrasound are combined through
advanced software algorithms to give physicians insight into maternal and fetal well-being. Beyond aneuploidy screening, this type of
coordinated testing offers new potential to help predict conditions
like preeclampsia, pre-term labor and fetal loss.1
Maternal screening uses risk calculation software that combines
first and/or second trimester biochemical markers, ultrasound imaging and demographic factors of the mother to arrive at a statistical risk
assessment. This technology is being used for prenatal risk assessment
with the capability of achieving up to a 95% detection rate.2
68 JULY 2010 • advance /Laboratory • www.advanceweb.com
Safer Screening for Aneuploidy
The potential benefits for physicians and
their patients are significant. A highly efficient screening program helps substantially
reduce the number of invasive diagnostic procedures like amniocentesis and chorionic villi
sampling. Although generally considered safe,
these diagnostic tests carry the potential risk
of miscarriage.
The screening model combines ultrasound
screening tests with serum markers used in the
first and/or second trimester. Support is growing for a combination of the newer ultrasound
and first trimester biomarkers to assess prenatal risk due to earlier identification of anomalies as well as higher detection rates. Patients
and physicians benefit by having advanced
information earlier in the pregnancy, allowing
for earlier counseling and diagnosis in case of
an increased risk for an affected pregnancy.
Patients at low risk may be able to avoid invasive diagnostic testing altogether.
Further, studies have shown an increase in
detection rate from 75% to 85% when first trimester markers are used rather than waiting
until the second trimester. And, when combined with ultrasound tests like Nuchal Translucency and Nasal Bone, detection rates can
even be higher, reaching as much as 95%.
The combination of biochemical and highquality imaging screening can also decrease
the false positive rate for fetal abnormalities,
where patients screen positive even though
they are unaffected. This helps to minimize
the number of unnecessary higher risk invasive procedures performed.
Critical for an accurate risk assessment is
the integration of maternal factors such as
maternal age and gestation age as well as other
information like smoking habits, ethnicity,
diabetes, multiple pregnancies and any previous affected pregnancies. Factors such as age,
weight, smoking and diabetes have been found
to increase the MoM (Multiple of Median)—
patient-specific biomarker results included in
the algorithm to assess risk.
Fetal, Maternal Wellness at the Forefront
When you look at the statistics, it’s not surprising that prenatal testing is increasingly focusing on fetal and maternal well-being by looking
at algorithms to predict such ­conditions
photo / courtesy siemens healthcare diagnostics
Prenatal Testing
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Living up to Life
Prenatal Testing
as preeclampsia and pre-term labor. Clinicians
and physicians are looking for new ways to
help reduce the prevalence of these maternal
and fetal health risks.
combination of first trimester biochemical
and ultrasonographic markers may be useful
in the prediction of early preeclampsia. For
example, combinations of PAPP-A, Pregnancy
Support is growing for a combination of the newer ultrasound and
first trimester biomarkers to assess prenatal risk due to earlier
identification of anomalies as well as higher detection rates.
In the U.S. alone, pre-term delivery affects
approximately one in 10 births and is the
cause of at least 75% of neonatal deaths,
excluding those related to congenital malformations.3 Globally, preeclampsia and other
hypertensive disorders of pregnancy are a
leading cause of maternal and infant illness
and death. By conservative estimates, these
disorders are responsible for 76,000 maternal
and 500,000 infant deaths each year.4
Early identification of risk for these conditions is a priority to implement preventive measures. Studies are suggesting that a
Associated Plasma Protein A; ADAM 12, a
disintegrin and metalloproteinase; activin
A or inhibin A measured in the first or early
in the second trimester, combined with uterine artery Doppler ultrasound in the second
trimester, appear promising with sensitivity
results of 60% to 80% and specificity >80%.5
More recently, research has shown an
improvement in preeclampsia predictive
accuracy by adding maternal characteristics to the prediction algorithm such as
ethnicity, body mass index and previous
maternal medical and obstetrical history.
The addition of these variables have been
found to increase sensitivity and consequently reduce false negative results.5
Methods used to predict preterm labor
include transvaginal ultrasonography, detection of fetal fibronectin, inflammation markers and maternal factors. Studies have shown
that cervical length may be a useful predictor
of premature delivery, with a shorter cervix
predicting a higher risk. Given the substantial variations that occur with digital examinations, it has been hoped that transvaginal
ultrasonography would provide a more reliable testing method. Further clinical trials
are needed to determine its role in predicting preterm labor.6
With regard to biomarkers, the most promising is the presence of fetal fibronectin. The
FDA recently approved an assay for fetal
fibronectin, which was found to be 10 times
more effective than any other risk factor or
clinical sign in predicting preterm delivery.
Prenatal Risk Assessment
First Trimester Screening
Calculating the risk of Down syndrome, Trisomy 18 or Trisomies 18 and 13
Biochemical markers include PAPP-A, βhCG, hCG, DIA
Ultrasound markers include NT, Nasal Bone, Tricuspid Regurgitation, Ductus Venosus,
Frontomaxillary Facial Angle and Fetal Heart Rate
Either MoMs or deltas for NT
Algorithms by Wald et al., Spencer, Nicolaides, Cuckle, Palomaki, SURUSS, and others
(including the option of mixed model NT)
Second Trimester Screening
For Down syndrome, Open Spina Bifida (OSB), Trisomy 18, and/or SLOS
Biochemical markers include AFP, uE3, βhCG, hCG, DIA and ITA
Multiple algorithms for both DS and OSB (Wald, Haddow, Palomaki, SURUSS, etc.)
Featuring
The ability to define multiple test panels, each with its own markers, algorithms and cut-offs
Integrated, Composite and Sequential screening (where not restricted by patent)
User defined races, with medians calculated directly, or derived from another race
IVF data entry (using either donor age or date of birth)
Adjustment for IDDM, smoking, Rh status and family history
HL7 (LIS) and device interfaces available
The most flexible prenatal screening software available
Responsive technical support via telephone, email and remote connection
Enterprise Version
Allows the sharing of a single physical database across several sites, connected either
by WAN or the Internet
Each site maintains its own patient records, medians and physicians
Both central and individual site statistical and QA reporting
Over 20 years of prenatal screening around the world
70 JULY 2010 • advance /Laboratory • www.advanceweb.com
Prenatal Testing
Significant research is also being conducted
in the area of inflammation markers since
infection is one of the most common causes
of preterm labor. Studies have suggested that
increased levels of C-reactive protein (CRP)
as well as cytokines interleukin-1 (IL-1), IL-6,
IL-8, IL-15 and tumor necrosis factor (TNF)
are associated with preterm delivery.7,8
Risk scoring strategies have also been
devised to assess a woman’s potential for
preterm birth based on socioeconomic status,
clinical history, lifestyle and past obstetric and
current perinatal complications. Today, there
is insufficient evidence from randomized trials or preterm preventive programs to suggest
that the use of risk scoring can reduce the incidence of preterm delivery.6
While promising research has been done
in the detection and prediction of preeclampsia and preterm labor, more work is needed in
both areas. Improved methods of early diagnosis would be a significant advancement in
the identification of women at risk for preeclampsia and preterm labor. n
Luis LaSalvia is head of Integrated Diagnostics and Market Development, Siemens
Healthcare Diagnostics.
References
1. Note: While significant research is being
conducted, these tests and algorithms are currently not approved in the U.S. for predicting
preeclampsia and preterm labor.
2. Note: Methods not FDA-cleared for aneuploidy screening.
3. American Family Physician, http://
www.aafp.org/afp/980515ap/vonderp.html
4. Preeclampsia Foundation, http://www.
preeclampsia.org/about.asp
5. Yves Giguere, Marc Charland, et al. Combining biochemical and ultrasonographic
markers in predicting preeclampsia: A systematic review. Clinical Chemistry 2010; 56:3.
6. American Family Physician, http://
www.aafp.org/afp/99021ap/593.html
7. American Journal of Epidemiology,
http://aje.oxfordjournals.org/cgi/content/
full/162/11/1108
8. Perinatal Research Center, http://
www.perinatalresearch.com/pnr/pretermLabour.html
advance /Laboratory • JULY 2010
71
Laboratory Analyzers buyers guide
2010
Laboratory
Analyzers
buyers guide
Editor’s note: This annual resource represents a collaborative
effort between ADVANCE editorial consultants/advisors, industry
manufacturers and editorial staff. A more detailed guide is
offered on our Website, www.advanceweb.com/labmanager.
ADVANCE relies on its readership for feedback. If you have
suggestions that would make the Buyers Guide more useful,
please e-mail lnace@advanceweb.com. Listings do not represent
endorsement by ADVANCE.
AB SCIEX
www.absciex.com
LC/MS/MS
Contact:
Lisa Sapp
(508) 259-4383
lisa.sapp@absciex.com
Product:
AB SCIEX QTRAP® 5500 LC/MS/MS System
Methodologies Used:
Multiple reaction monitoring (MRM) for quantitation
using high-sensitivity triple quadrupole system
Tests Available
in the U.S.:
Not cleared or approved by the FDA or any other
agency, or under the European IVD Directive, for
diagnostic or other clinical use.
Throughput:
Application dependent
Time to First Result:
3 to 6 months for validation
Sample Size:
5 µL/min to 3 mL/min
Frequency of
Calibration:
Weekly
What differentiates
your product from
others on the market?
Superior sensitivity, low detection limits, high
specificity, faster results, reduced sample
preparation time, increased throughput, easy to
use, easy analyte updates, maximum instrument
uptime, cost savings. Includes open reagent
system, primary tube sampling and positive
sample ID.
Operational Type:
All
Separation
Methodologies:
Liquid chromatography and MRM
Sample Handling
System:
Any
Number of Reagent
Containers Onboard/
Tests/Container:
Depends on the type of autosampler used
Reagents Refrigerated
Onboard:
Cooling rack
Walkaway Capacity
in Specimen/
Tests Assays:
Yes
System Liquid or Dry:
Liquid
15 minutes
AUTOMATION
PG
IMMUNOASSAY
PG
Bio-Rad Laboratories
74
The Binding Site
73
Roche Diagnostics
78
DiaSorin Inc.
74
Siemens Healthcare
Diagnostics
79
Inverness Medical
75
Phadia US Inc.
78
Average Length of
System Startup Time
and Daily Maintenance:
CHEMISTRY
PG
Roche Diagnostics
78
Alfa Wassermann Diagnostic Technologies LLC
Alfa Wassermann
Diagnostic
Technologies LLC
72
Siemens Healthcare
Diagnostics
83
CHEMISTRY
The Binding Site
73
INTEGRATED SYSTEMS
PG
Mindray Medical
International Ltd.
76
Siemens Healthcare
Diagnostics
85
Nova Biomedical
77
LC/MS/MS
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Roche Diagnostics
78
AB SCIEX
72
Siemens Healthcare
Diagnostics
URINALYSIS
PG
80
89
COAGULATION
PG
Siemens Healthcare
Diagnostics
Beckman Coulter
73
Siemens Healthcare
Diagnostics
81
HEMATOLOGY
PG
Mindray Medical
International Ltd.
76
Siemens Healthcare
Diagnostics
88
www.alfawassermannus.com
Contact:
Lauren DiPrima
(800) 220-4488
info@alfawassermannus.com
Product:
ACE Alera Clinical Chemistry System
Methodologies Used:
Photometry, potentiometry (Ion Selective Electrode),
turbidemetric/homgeneous EIA
Tests Available
in the U.S.:
Alanine Aminotransferase, Albumin, Alkaline
Phosphatase, Amylase, Apolipoprotein A1,
Apolipoprotein B, Aspartate Aminotransferase,
Bilirubin, Direct, Bilirubin, Total, Blood Urea
Nitrogen, Calcium Arsenazo , Carbon Dioxide,
Cedia T-Uptake, Chloride, Cholesterol, Creatine
Kinase, Creatinine, Ferritin, Gamma-Glutamyl
Transferase, Glucose, Hemoglobin A1c, High
Density Lipoprotein, Cholesterol, Inorganic
Phosphorous, Iron, Lactate Dehydrogenase,
Lipase, Lipoprotein-a, Low Density Lipoprotein,
Cholesterol, Magnesium, Microalbumin, Potassium,
Sodium, TIBC, Direct, Total Protein, Total Thyroxine,
Transferrin, Triglycerides, Uric Acid
Throughput:
165 photometric, 120 ISE
72 JULY 2010 • advance /Laboratory • www.advanceweb.com
Time to First Result:
2-10 minutes, assay dependent
Sample Size:
3-50 µL, assay dependent
Frequency of
Calibration:
Assay dependent
What differentiates
your product from
others on the market?
Closed tube sampling, integrated data
management, positive sample ID, primary tube
sampling, open reagent system, onboard dilution
Operational Type:
Continuous random access
Separation
Methodologies:
Primary tube, sample tube or cup
Sample Handling
System:
Centrifugation
Number of Reagent
Containers Onboard/
Tests/Container:
40 positions
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
2-4 hour walkaway time
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
<15 minutes
Beckman Coulter
www.beckmancoulter.com
COAGULATION
Tests Available
in the U.S.:
PT, APTT, Fibrinogen, TT, Factor Assays, SCT,
dRVVT, APCR-V, Protein C/S, Heparin, AT
Plasminogen, Plasmin Inhibitor, D-Dimer, D-Dimer
HS, vWF, Factor XIII, Homocysteine
Throughput:
Up to 240 PTs/hour
Time to First Result:
<3 minutes
Sample Size:
PT & PTT - 50 µL; FVIII - 25 µL
Frequency of
Calibration:
Varies by assay
What differentiates
your product from
others on the market?
Complete assay menu, including D-dimer and
D-dimer HS with VTE exclusion; 671 nm LED
detection minimizes interference from lipemia,
hemoglobin and bilirubin; HemosIL® plasma sets
for validation of INR test system; HemosIL liquid
heparin with universal cal curve for UFH and
LMWH. Includes integrated data management,
primary tube sampling and onboard dilution.
Number of Reagent
Containers Onboard/
Tests/Container:
120 samples on board (10 samples per rack); 800
cuvettes on board; 30 tests per sample
Reagents Refrigerated
Onboard:
44
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <10 minutes
Product:
ACL ELITE® Series
Methodologies Used:
Clot detection, LED optical, chromogenic,
immunologic
Tests Available
in the U.S.:
PT, APTT, Fibrinogen, TT, Factor Assays, SCT,
dRVVT, APCR-V, Protein C/S, Heparin, AT
Plasminogen, Plasmin Inhibitor, D-Dimer, vWF,
Factor XIII, Homocysteine
Contact:
Venita Shirley
(714) 961-4252
vshirley@beckman.com
Product:
ACL TOP®
Methodologies Used:
Clot detection, LED optical, chromogenic,
immunologic
Throughput:
175 PTs/hour
Time to First Result:
4 minutes
Tests Available in the
U.S.:
PT, APTT, Fibrinogen, TT, Factors, SCT, dRVVT,
APCR-V, Protein C/S, Heparin, AT Plasminogen,
Plasmin Inhibitor, D-Dimer, D-Dimer HS, vWF,
Factor XIII, Homocysteine
Sample Size:
PT 60 µL
Throughput:
Up to 360 PTs/hour
What differentiates
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Time to First Result:
PT<3 minutes
Sample Size:
PT & PTT - 50 µL; FVIII - 25 µL
Test menu features D-Dimer; barcode reagent
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HemosIL® INR plasma sets for INR test system
validation and calibration; HemosIL liquid heparin
with universal cal curve for UFH and LMWH.
Includes integrated data management, primary
tube sampling and onboard dilution.
Frequency of
Calibration:
PT & PTT - 50 µL; FVIII - 25 µL
Up to 40 samples onboard
What differentiates
your product from
others on the market?
Features clot signature curve analysis;
continuous operation without interruption to
workflow; minimized operator intervention using
Windows XP software; 2D bar code for reagent,
calibration and control assay value import;
HemosIL® INR plasma sets for INR test system
validation and calibration; HemosIL liquid heparin
with universal cal curve for UFH and LMWH.
Includes integrated data management, primary
tube sampling and onboard dilution.
Number of Reagent
Containers Onboard/
Tests/Container:
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <5 minutes
Number of Reagent
Containers Onboard/
Tests/Container:
120 samples on board (10 samples per rack); 800
cuvettes on board; 30 tests per sample
Reagents Refrigerated
Onboard:
44
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <10 minutes
Product:
ACL TOP ® 500 CTS
Methodologies Used:
Clot detection, LED optical, chromogenic,
immunologic (turbidimetric)
The Binding Site
www.thebindingsite.com
CHEMISTRY/IMMUNOASSAY
Contact:
Faranak Atrzadeh
(800) 633-4484
faranak.atrzadeh@thebindingsite.com
Product:
SPA PLUS Special Protein Analyzer
Methodologies Used:
Turbidimetry
Tests Available in the
U.S.:
Freelite Kapp (Free Kappa Light Chain), Freelite
Lambda (Free Lambda Light Chain), Beta-2Microglobulin, IgG, IgA, IgM, IgD, IgG1, IgG2, IgG3,
IgG4, Cystatin C, T. Tox Plasma Screen (RUO)
Throughput:
240 tests per hour (up to 120 tests per hour with
sample dilution)
Time to First Result:
15 minutes, and each consecutive sample every
30 seconds
www.advanceweb.com • advance /Laboratory • JULY 2010
73
Laboratory Analyzers buyers guide
Sample Size:
3-30 µL
What differentiates
your product from
others on the market?
Prozone detection, Auto-dilution Dual
Compartment reaction cuvettes, air pressure
mixing system and extensive washing processes
ideal especially for latex assays, low maintenance,
integrated data management, primary tube
sampling, positive sample ID, onboard dilution
Operational Type:
Batch, random access
Separation
Methodologies:
Homogenous
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
24 reagent positions; 100 tests per container;
onboard reagent cooling; 30-day onboard
reagent stability
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
45 specimens, 6 assays
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
~15 minutes
Number of Reagent
Containers Onboard/
Tests/Container:
Onboard reagent storage: 10 microplates with
positive plate and strip identification 12 cooled
liquid reagent positions (reagent red cells) 6 RT
liquid reagent positions (bromelin, LISS and antiIgG) 48 2-cell screens / plate (96 wells) 12 blood
typing / plate (96 wells) 48 ABO or Rh confirmation
typing / plate (96 wells) 550 tests / reagent red cell
bottle & anti-IgG bottle 1400 tests / LISS bottle
Reagents Refrigerated
Onboard:
Yes, up to 7 days
Walkaway Capacity
in Specimen/
Tests Assays:
Yes
System Liquid or Dry:
Both
Average Length of
System Startup Time
and Daily Maintenance:
Hands-on 5 minutes, total 5 minutes
DiaSorin Inc.
www.diasorin.com
IMMUNOASSAY
Contact:
Greta Schwichtenberg
(800) 328-1482
greta.schwichtenberg@diasorin.com
Product:
LIAISON®
Methodologies Used:
Fully-automated random access chemiluminescent
Tests Available
in the U.S.:
25 OH Vitamin D, N-Tact PTH, EBV IgM, VCA
IgG, EBNA IgG, EA(D) IgG, CMV IgG, CMV IgM,
Toxo IgG, Toxo IgM, VZV IgG, Treponema (IgG/
IgM), Borrelia burgdorferi, Rubella IgG, HSV-1 Type
Specific IgG, HSV-2 Type Specific IgG, HAV Total
Antibodies, HAV IgM, hGH, insulin
Throughput:
Max 180 tests per hour, assay dependent
Time to First Result:
17-35 minutes, assay dependent
Sample Size:
As low as 5 µL, assay dependent
Frequency of
Calibration:
1-4 weeks, assay dependent
What differentiates
your product from
others on the market?
A fully-automated, random access
chemiluminescent analyzer available for 25OH
Vitamin D, Treponema IgG/IgM, HSV-1 and
HSV-2 Type Specific IgG, VZV IgG, CMV IgM and
Borrelia burgdorferi assays. Offers integrated data
management, primary tube sampling, positive
sample ID and onboard dilution.
Operational Type:
Random access, batch mode setting also available
Separation
Methodologies:
Paramagnetic microparticle
ABO Forward and Reverse Grouping with D
Typing, ABO and Rh Donor Confirmation, Antibody
Screen Testing, Compatibility Testing, Direct
Antiglobulin Testing, Antibody Identification, Weak
D Testing, Phenotype Testing
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
Capacity for 15 reagent integrals/up to 3,000 tests
onboard/50-200 tests per reagent integral
Throughput:
24 blood typing / 60 minutes 96 2-cell screens
Yes
Time to First Result:
17 minutes for typing, 32 minutes for screen
Reagents Refrigerated
Onboard:
Sample Size:
500 microliters
144 samples/1,500 tests/15 assays
What differentiates
your product from
others on the market?
Long onboard reagent shelf lives (up to 7 days),
unique solid phase and erytype technology, stat
capability, quick and simple daily and weekly
maintenance, easy to operate, processes strips
individually for minimal waste, reagents have
up to a 2 year shelf life. Offers integrated data
management, open reagent system, primary tube
sampling, positive sample ID and onboard dilution.
Walkaway Capacity
in Specimen/
Tests Assays:
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
20 minutes
Operational Type:
Continuous random access
Contact:
Sample Handling
System:
Rack
Lance Schlenker
(800) 328-1482
lance.schlenker@diasorin.com
Product:
ETI-MAX 3000
Bio-Rad Laboratories
www.bio-rad.com
AUTOMATION
Contact:
Maria Rosa Spedaletti
(510) 741-5789
maria-rosa_spedaletti@bio-rad.com
Product:
TANGO optimo
Type of Analyzer:
Automated blood bank instrument
Methodologies Used:
Hemagglutination is used for the Erytype
assays. Dried monoclonal antisera coats the
microwells. The placement and identity of the
antisera is predetermined. Patient sample is
added and reactions are graded and interpreted
by the instrument. For the Solidscreen II
assays, a solid phase method is employed.
Uses microwells coated with Protein A that has
a high affinity for the Fc portion of the antihuman globulin which attaches also to patient
antibody. Solid phase offers advantages such
as long shelf-life, long on-board stability and
outstanding specificity and sensitivity.
Tests Available
in the U.S.:
74 JULY 2010 • advance /Laboratory • www.advanceweb.com
Methodologies Used:
Microplate analyzer
Tests Available
in the U.S.:
Infectious disease and autoimmune ELISA; contact
manufacturer for detailed assay information
Throughput:
Assay dependent
Time to First Result:
2.5-5 hours, assay dependent
Sample Size:
>10 µL, assay dependent
What differentiates
your product from
others on the market?
Complete infectious disease and autoimmune
menu; offers integrated data management, open
reagent system, primary tube sampling, positive
sample ID and onboard dilution.
Operational Type:
Batch
Separation
Methodologies:
ELISA microplate
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
Capacity: reagents for up to 384 tests onboard
Reagents Refrigerated
Onboard:
No
Walkaway Capacity
in Specimen/
Tests Assays:
160 samples/384 tests/8 assays
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
20 minutes
Inverness Medical
www.invernessmedicalpd.com
Sample Handling
System:
Manual
Number of Reagent
Containers Onboard/
Tests/Container:
0
Walkaway Capacity
in Specimen/
Tests Assays:
20-40 minutes
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
30 minutes
Product:
AIMS® System
Methodologies Used:
Multiplex and ELISA methodologies
Tests Available
in the U.S.:
ANA (ANA, dsDNA, Sm, RNP, SSA, SSB, Jo-1,
Sci-70, Centromere B, Histones); Autoimmune
Vasculitis (MPO, PR-3, GBM); TPO/Tg (Thyroid
Peroxidase, Thyroglobulin); RF IgM (Rheumatoid
Factor); EBV-IgG (VCA, EBNA-1, EA); EBV-IgM
(VCA); MMRV IgG (Measles, Mumps, Rubella,
Varicella Zoster); MMV IgG (Measles, Mumps,
Varicella Zoster); HSV 1&2 IgG (Herpes Simplex
Virus, Type 1 & Type 2); Wampole II ELISAs;
Pending FDA approval: Torch IgG Plus Test System
(Toxoplasma gondii, rubella, cytomegalovirus, and
HSV-1/2, Type-specific), and the Borrelia VIsE-1/
pepC10 Plus Test System (detects IgG and IgM
antibodies to VIsE-1 and pepC10, Lyme).
Throughput:
Two 96-well plates at one time with up to 4 assays
Time to First Result:
3 hours for one 96-well plate for AtheNA MultiLyte® assays; 1.5 hours for one 96-well plate for
ELISA assays
Sample Size:
12 sample racks, 20 sample tube positions for 240
samples
Frequency of
Calibration:
Every 6 months
What differentiates
your product from
others on the market?
The Automated Immunoassay Multiplexing System
or AIMS is the first fully automated, integrated,
open, multi-methodology platform for performing
both multiplex assays (AtheNA Multi-Lyte®)
and ELISAs. Laboratories can now consolidate
workstations and maximize their versatility for
autoimmune and infectious disease testing.
Includes integrated data management, open
reagent system, primary tube sampling, positive
sample ID and onboard dilution.
Operational Type:
Batch
Separation
Methodologies:
AtheNA Multi-Lyte: Bead; ELISA: Microwell-plate
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
AtheNA Multi-Lyte: 4 Reagent Racks holding up
to 7 reagent bottles and 6 control vials; ELISA: 4
Reagent Racks holding up to 6 reagent bottles and
6 control vials
Reagents Refrigerated
Onboard?
No
Walkaway Capacity
in Specimen/
Tests Assays:
192 samples
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
15 minutes
Product:
DSX®
IMMUNOASSAY
Contact:
Michelle Fradette
(877) 546-8633
bodytalks@invmed.com
Product:
AtheNA Multi-Lyte®
Methodologies Used:
The AtheNA® is a multiplexed, fluorescent, beadbased system using patented xMAP® technology.
Tests Available
in the U.S.:
ANA test system (ANA screen, dsDNA, Sm, RNP,
SSA, SSB, Jo-1, Scl-70, centromere b, histones),
EBV-G test system (VCA, EBNA, EA), EBV-M test
system (VCA), Autoimmune Vasculitis (MPO, PR-3,
GBM), TPO/Tg, RF, MMV IgG test system (measles,
mumps, varicella), MMRV IgG test system
(measles, mumps, rubella, varicella), HSV (type
specific HSV-1, HSV-2). Later in 2010, pending FDA
approval, the menu will include the AtheNA MultiLyte® Torch IgG Plus Test System (Toxoplasma
gondii, rubella, cytomegalovirus, and HSV-1/2,
Type-specific), and the AtheNA Multi-Lyte Borrelia
VIsE-1/pepC10 Plus Test System (detects IgG and
IgM antibodies to VIsE-1 and pepC10, Lyme).
Throughput:
1 96-well plate in approximately 2 hours
Time to First Result:
2 hours for 96-well plate for all analytes in a specific
test system
Sample Size:
10 μL human sera
Frequency of
Calibration:
Every well undergoes a unique calibration curve
generated at the time of testing, Intra-Well
calibration™
What differentiates
your product from
others on the market?
Broadest FDA-cleared multiplex diagnostic menu;
each AtheNA Multi-Lyte® Test System utilizes
Intra-Well Calibration™, offers integrated data
management, open reagent system and positive
sample ID
Operational Type:
Batch
Separation
Methodologies:
Heterogeneous, vacuum wash
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75
Laboratory Analyzers buyers guide
Methodologies Used:
ELISA 4-plate processing system
Tests Available
in the U.S.:
Chlamydia, CMV, EBV-EA, EBNA, EBV-VCA, H.
pylori, HSV, Legionella, Lyme, Measles, Mumps,
Myco, Parvovirus B-19, Rubella, Syphillis,
Toxo, VZV. AI-ANCA, ANA, CCP, ASCA, Beta 2,
Cardiolipins, dsDNA, ENA, Gliadin, Histone, Jo-1,
Mitochondria, MPO, PR-3, RF, Ribosomal P, Scl70, SM, SM/RNP, SS-A, SS-B, TPO, TG, TTG.
Osteo- NTx, Bladder Cancer NMP22, Enterics
– Tox AB, GDH, Crypto, Giardia, E Histo, ASCA,
IBD, Leuko
Throughput:
Up to 12 different assays per plate simultaneously
in up to four 96-well microplates
Time to First Result:
Approximately 2 hours for a full 96-well plate
Sample Size:
10-20 μL sample tube positions for 96 samples
Frequency of
Calibration:
Lot specific
What differentiates your
product from others on
the market?
Completely open system allows lab to run
virtually any ELISA-based assay. Modular
design allows the lab to customize the system
by adding extra incubators, including a bar
code scanner, or even choosing certain
types of sample racks. Offers integrated data
management, primary tube sampling, positive
sample ID and onboard dilution.
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
18 reagent plus 24 control containers
Reagents Refridgerated
Onboard?
No
Walkaway Capacity
in Specimen/
Tests Assays:
Performs entire complement of analytical steps
required for ELISA immunoassays; adding samples
and reagents, washing, incubation and absorbance
detection
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
5 minutes
Mindray Medical International Ltd.
www.mindray.com
CHEMISTRY/HEMATOLOGY
Contact:
Caroline Li
(416) 890-7659
c.li@mindray.com
Product:
BS-200 Chemistry Analyzer
Methodologies Used:
Photometric, Turbidimetry, and ISE
Tests Available
in the U.S.:
General Chemistry: Albumin, Alkaline Phosphatase,
ALT, Amylase, AST, Direct Bilirubin, Total Bilirubin,
BUN, Calcium, Carbon Dioxide, Cholesterol, CK,
Creatinine, CRP hs, Fructosamine, Gamma GT,
Glucose, HbA1c, autoHDL, Iron, LD, autoLDL,
Lipase-Color, Magnesium, Phosphorus, Total
Protein, Triglycerides, Uric Acid Drug of Abuse:
Amphetamines, Barbiturates, Benzodiazepines,
Buprenophine, Cocaine, Dronabinol (THC), Ethanol
(Alcohol), Ethchlorvynol, Fentanyl, Methadone,
Methampheta, Opiates, Oxycodone, Phencyclidine,
Propoxphine, TCA, XTC, 6-Acetylmorphine
Throughput:
200 tests/hour for photometric tests, 330 tests/hour
with ISE
Operational Type:
Batch
Separation
Methodologies:
Coated microwell
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
24 reagent plus 33 control containers
Reagents Refridgerated
Onboard?
No
Walkaway Capacity
in Specimen/Tests
Assays:
Perform entire complement of analytical
steps required for ELISA immunoassays; adding
samples and reagents, washing, incubation and
absorbance detection
Time to First Result:
3-10 minutes
System Liquid or Dry:
Liquid
Sample Size:
3-45 µL
Average Length of
System Startup Time
and Daily Maintenance:
5 minutes
What differentiates
your product from
others on the market?
Product:
DS2®
Methodologies Used:
ELISA 2- plate processing system
Open system allowing mixes and matches of
quality reagents at low cost. Equipped with features
that only come with high-volume instrument.
Zero daily maintenance. Asian design with great
reliability and accuracy. Includes integrated data
management, positive sample ID, primary tube
sampling and onboard dilution.
Tests Available
in the U.S.:
Chlamydia, CMV, EBV-EA, EBNA, EBV-VCA, H.
pylori, HSV, Legionella, Lyme, Measles, Mumps,
Myco, Rubella, Syphillis, Toxo, VZV. AI-ANCA,
ANA, CCP, ASCA, Beta 2, Cardios, dsDNA, ENA,
Gliadin, Histone, Jo-1, Mitochondria, MPO, PR-3,
RF, Ribosomal P, Scl-70, SM, SM/RNP, SS-A,
SS-B, TPO, TG, TTG. Osteo- NTx, Bladder Cancer
NMP22, Enterics – Tox AB, GDH, Crpto, Giardia, E
Histo, ASCA, IBD, Leuko
Operational Type:
Random access
Sample Handling
System:
Ring
Number of Reagent
Containers Onboard/
Tests/Container:
38 onboard chemistries and 40 samples
Reagents Refrigerated
Onboard:
38
Up to 12 different assays per plate simultaneously
in up to two 96-well microplates
System Liquid or Dry:
Liquid
Sample Size:
10-20 μL sample tube positions for 100 samples
5 minutes daily startup; no daily maintenance
What differentiates
your product from
others on the market?
Small automated option for manual customers
looking to automate. It’s completely open system
allows a customer to run virtually any ELISAbased assay; offers integrated data management,
primary tube sampling, positive sample ID and
onboard dilution.
Average Length of
System Startup Time
and Daily Maintenance:
Product:
BS-380
Methodologies Used:
Turbidimetry, colorimetry
Tests Available
in the U.S.:
AST, ALT, ALP,Na, K, CL, CA, TP, Albumin,
Cholesterol, HDL, Iron, Phos, D.Bili, T.Bili, TG, CRP,
BUN, Uric Acid, CK, CKMB, Creat, Gluc, GGT,
LDH, LDL
Throughput:
Operational Type:
Batch
Separation
Methodologies:
Coated well
76 JULY 2010 • advance /Laboratory • www.advanceweb.com
Throughput:
450 tests/hour with ISE
Sample Size:
2-45 µL
Frequency of
Calibration:
Weekly or bi-weekly
What differentiates
your product from
others on the market?
Automated chemistry analyzer, 450 T/H with ISE, 75
sample position, 58 reagent position, refrigerated
reagent compartment, carryover minimizing
program, automatic on board predilution, automatic
probe clean, level sense detection, vertical and
horizontal collision protection, 8 steps cuvette wash,
12 wavelength: 340 - 800nm, LIS connectivity.
Includes integrated data management, primary tube
sampling, positive sample ID, onboard dilution and
an open reagent system.
Operational Type:
Random access and batch
Separation
Methodologies:
Sample disk
Number of Reagent
Containers Onboard/
Tests/Container:
60 reagent container position
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
80
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
10 minute startup time; <5 minutes daily
maintenance
Tests Available
in the U.S.:
CBC, 3-part differential
Throughput:
60 tests/hour
Time to First Result:
1 minute
Sample Size:
13 µL for whole blood, 20 µL for pre-diluted blood
Frequency of
Calibration:
As required by local inspecting agency
What differentiates
your product from
others on the market?
Flagging of abnormal QC results; large en suite
database storage: 558 (up to 6-month) QC
files and 35,0000 test results with histograms.
Automatic start-up, close-down cleaning and
programmable cleaning cycles. Includes integrated
data management, primary tube sampling, positive
sample ID and onboard dilution.
Operational Type:
Single sample
Sample Handling
System:
4-position tube holders for different types of tubes
Separation
Methodologies:
Homogenous, no separation
Number of Reagent
Containers Onboard/
Tests/Container:
3 reagents
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
5 minutes
Nova Biomedical
www.novabiomedical.com
CHEMISTRY
Product:
BC-5380
Methodologies Used:
Flow cell, laser scatter, chemical dye, DC
impedence
Tests Available
in the U.S.:
CBC with 5-part differential
Throughput:
60 tests/hour
Sample Size:
20 µL
Frequency of
Calibration:
As needed
What differentiates
your product from
others on the market?
5-part diff hematology analyzer, 27 parameters, 3
histogram, 1 scattergram, load up to 30 samples
with autoloader, closed tube compartment for
stats, whole blood and predilution mode, data
storage: up to 40,000 samples, Semi-conductor
laser scatter, Flow Cytometry, chemical dye
method, compact, powerful and affordable for any
laboratory. Includes integrated data management,
primary tube sampling, positive sample ID and an
open reagent system.
Operational Type:
Autoloader, stat, random access
Sample Handling
System:
Autoloader rack
Reagents Refrigerated
Onboard:
No
Walkaway Capacity
in Specimen/
Tests Assays:
60 samples/hour
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
<10 minutes start-up time; <5 minutes daily
maintenance
Product:
BC-3200
Methodologies Used:
Impedance and cyanide-free photometry method
Contact:
Richard Rollins
(781) 647-3700
marketing@novabiomed.com
Product:
Stat Profile® pHOx
Methodologies Used:
Depending on test: direct ISE; enzyme/
amperometric
Tests Available
in the U.S.:
pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-,
Ca++, Mg++, Glucose, BUN, Creatinine, Lactate,
tBil, HHb, O2Hb, MetHb, COHb
Throughput:
Up to 50 samples per hour
Time to First Result:
50 to 123 seconds
Sample Size:
40-210 microliters (depending upon menu selected)
Frequency of
Calibration:
Fully automatic 2-point calibration every 2 hours;
user-selectable
What differentiates
your product
from other products
on the market?
Color touch screen; integrated co-oximeter;
calculates eGFR with creatinine measurement;
snap-in reagent cartridges with sealed waste
system; automated, onboard quality control;
tankless gas calibration; SmartCheck automated
maintenance; integrated data management;
primary tube sampling; positive sample ID; ionized
Mg assay. Includes integrated data management,
primary tube sampling, positive sample ID and
onboard dilution.
Operational Type:
Single sample
Separation
Methodologies:
Whole blood
Number of Reagent
Containers Onboard/
Tests/Container:
Up to 5 snap-in reagent cartridges with sealed
waste system
Reagents Refrigerated
Onboard:
No
Walkaway Capacity
in Specimen/
Tests Assays:
One
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77
Laboratory Analyzers buyers guide
System Liquid or Dry:
Liquid
Product:
cobas c 311 analyzer
Average Length of
System Startup Time
and Daily Maintenance:
Cold startup time: 5 minutes. No daily maintenance
required
Methodologies Used:
Photometric, ISE, immunoturbidimetric
Tests Available
in the U.S.:
Substrates, enzymes, ISE, drugs of abuse,
therapeutic drugs, specific proteins, whole blood
HbA1c
Throughput:
Up to 300 results per hour
Time to First Result:
5 minutes
Sample Size:
Typically 2-10 µL
Frequency of
Calibration:
Typically once per lot
Other Utility
Requirements:
Deionized water
What differentiates
your product from
others on the market?
Standardized chemistry solution
incorporates common reagents and user
interface (similar to other cobas modular
series analyzers). Combines ease of use and
proven Hitachi reliability. Offers integrated
data management, open reagent system,
primary tube sampling, positive sample
ID and onboard dilution.
Phadia US Inc.
www.phadia.us
IMMUNOASSAY
Contact:
Nicole Vosters
(800) 346-4364
nicole.vosters@phadia.com
Product:
ImmunoCAP Specific IgE Blood Test, EliA
Autoimmune Assays
Methodologies Used:
FEIA
Tests Available
in the U.S.:
SIgE, TIgE, TG, TPO, EliA CCP, dsDNA,
Symphony(ENA Screen), individual ENA's, Celikey
IgA/IgG (tTG) , Gliadin IgA/IgG.
Throughput:
48 tests
Roche Diagnostics
https://us.labsystems.roche.com
AUTOMATION
Operational Type:
Continuous random access
Contact:
Ed Duning
(317) 521-4710
Ed.duning@roche.com
Separation
Methodologies:
Homogenous
Product:
Modular Pre-Analytics
Sample Handling
System:
108 position sample disk
Methodologies Used:
Text
Maximum of 400 samples per hour with 2
centrifuges
Number of Reagent
Containers Onboard/
Tests/Container:
42 reagent positions (75 - 800 tests per c pack)
Throughput:
Sample Size:
Varies by number of tests requested
Yes
What differentiates
your product from
others on the market?
Modular design allows for customization and
increased efficiency and productivity. Connections
to analytics can be made in any direction. Industry
leading system reliability and service. Provides
integrated data management, primary tube
sampling and positive patient ID.
Reagents Refrigerated
Onboard:
Walkaway Capacity
in Specimen/
Tests Assays:
Up to 100 samples
System Liquid or Dry:
Liquid
Average Length of Daily
Startup Time and Daily
Maintenance:
Startup: 5 minutes; daily maintenance: <30 minutes
Operational Type:
Continuous random access
Sample Handling
System:
5-position rack
Walkaway Capacity
in Specimen/
Tests Assays:
300 samples
Contact:
Sheila Brewer
(317) 521-4804
Sheila.brewer@roche.com
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance: <5 minutes per day
Product:
cobas 6000 analyzer series
Methodologies Used:
Photometry, ISE, homogeneous
immunoassay, immunoturbidimetric,
electrochemiluminescence
Contact:
Scott Erekson
(317) 521-4011
scott.erekson@roche.com
Tests Available
in the U.S.:
Substrates, enzymes, ISE's, drugs of abuse,
therapeutic drugs, specific proteins, whole blood
HbA1c, cardiac, thyroid, bone, fertility
Product:
cobas p 501/cobas p Post Analytical Unit
Throughput:
Methodologies Used:
Post analytical units for specimen storage and
retrieval
Up to 1,000 tests per hour for chemistry and 170
tests per hour for immunoassay
Time to First Result:
Assay dependent, 5-27 minutes
Throughput:
400 tubes/hour
Sample Size:
Typically 2-50 µL
What differentiates
your product from
others on the market?
Provides automated storage and retrieval for many
different sample and tube types in a small footprint.
It provides a quick retrieval time for add-on
testing and allows a customized disposal process.
Includes integrated data management.
Frequency of
Calibration:
Typically once per lot
What differentiates your
product from others on
the market?
Second generation integrated analyzer
combining chemistry and immunoassay.
Modular design (seven different configurations)
for customization. Chemistry or immunoassay
modules can be added at a later date. Offers
integrated data management, primary tube
sampling, open reagent system, positive sample
ID and onboard dilution.
Operational Type:
Continuous random access
Sample Handling
System:
CHEMISTRY/IMMUNOASSAY
5-position rack
CHEMISTRY
Contact:
Adam Sterle
(317) 521-3099
Adam.sterle@roche.com
78 JULY 2010 • advance /Laboratory • www.advanceweb.com
Separation
Methodologies:
Homogeneous immunoassay (chemistry),
heterogeneous immunoassay (IA)
Tests Available
in the U.S.:
Cardiac, thyroid, bone, tumor, fertility, infectious
disease
Sample Handling
System:
5 position rack
Throughput:
Up to 88 results per hour
Time to First Result:
9-18 minutes
Number of Reagent
Containers Onboard/
Tests/Container:
Up to 60 reagent c-packs (75-800 tests each) and
3 ISE's for chemistry, up to 25 different assays for
immunoassay
Sample Size:
10-50 µL
Typically once per lot
Reagents Refrigerated
Onboard:
Yes
Frequency of
Calibration:
Walkaway Capacity
in Specimen/Tests
Assays:
Up to 150 samples
What differentiates
your product from
others on the market?
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Startup: <5 minutes; daily maintenance:
<30 minutes
Fully automated system for low end sensitivity
and broad assay ranges. Utilizes common IA
reagent packaging and user interface, allowing for
minimized training. 9 minute assays available for
critical tests including TnT, CK-MB, Myoglobin,
HCG and PTH. Offers integrated data management,
primary tube sampling, positive sample ID and
onboard dilution.
Operational Type:
Continuous random access
Separation
Methodologies:
Heterogeneous immunoassay
(electrochemiluminescence)
Sample Handling
System:
5 position rack or 30 position disk
Number of Reagent
Containers Onboard/
Tests/Container:
Up to 18 reagent positions, 100-200 tests per kit
Reagents Refrigerated
Onboard:
Yes
Contact:
Nathan Patton
(317) 521-2285
Product:
Modular Analytics
Methodologies Used:
Photometry, ISE, immunoturbidometry,
electrochemiluminescence
Tests Available
in the U.S.:
Substrates, enzymes, ISE, drugs of abuse,
therapeutic drugs, specific proteins, cardiac,
thyroid, bone, fertility
Throughput:
D module: up to 2,400 results per hour; P module:
up to 800 results per hour; E module: up to 170
results per hour; ISE up to 1,800 results per hour
Walkaway Capacity
in Specimen/
Tests Assays:
75 or 30 samples
Time to First Result:
<5 minutes
System Liquid or Dry:
Liquid
Sample Size:
Typically 2-50 µL
Frequency of
Calibration:
Typically once per lot
Average Length of
System Startup Time
and Daily Maintenance:
Startup: <10 minutes; daily maintenance:
<10 minutes
What differentiates
your product from
others on the market?
Integrated modular system consisting of D module
for high volume chemistries, P module for all
chemistries including esoterics, E module for
immunoassay. Modular design for customization
and upgrading. Ability to seamlessly connect to
automation. Offers integrated data management,
primary tube sampling, positive sample ID, onboard
dilution and open reagent system.
Siemens Healthcare Diagnostics
www.usa.siemens.com/diagnostics
AUTOMATION
Contact:
Eric LaFleche
(914) 524-3823
eric.lafleche@siemens.com
Product:
ADVIA® LabCell® /WorkCell® Solutions
Operational Type:
Continuous random access
Methodologies Used:
Configuration dependent
Separation
Methodologies:
Homogeneous and heterogeneous immunoassay
Tests Available
in the U.S.:
Configuration dependent
Sample Handling
System:
5-position rack
Throughput:
Configuration dependent
Time to First Result:
Configuration dependent
Number of Reagent
Containers Onboard/
Tests/Container:
D module: 16 reagent positions (500 - 4,000 tests);
P module: 44 reagent positions (100 - 1,000 tests);
E module: 25 reagent positions (100 - 200 tests)
Sample Size:
Configuration dependent
Configuration dependent
Reagents Refrigerated
Onboard:
Yes
Frequency of
Calibration:
Walkaway Capacity
in Specimen/
Tests Assays:
Up to 300 samples
What differentiates
your product from
others on the market?
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
<25 minutes
Customizable approach to total laboratory
automation. Unique design allows automation to
be implemented in stages. Multiple configuration
options allow for chemistry, immunoassay,
hematology, urinalysis and coagulation instrument
connectivity on one platform. Single workstation
to review results and monitor instruments. Large
onboard menu minimizes need for aliquotting.
Each analyzer can function independently. Offers
integrated data management, open reagent
system, primary tube sampling, positive sample ID
and onboard dilution. Samples may be stored in
automation racks for archiving and easy retrieval for
add on testing.
Operational Type:
Continuous random access
Separation
Methodologies:
Configuration dependent
IMMUNOASSAY
Contact:
Adam Sterle
(317) 521-3099
Adam.sterle@roche.com
Product:
cobas e 411 analyzer
Methodologies Used:
Electrochemiluminescence
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79
Laboratory Analyzers buyers guide
Sample Handling
System:
Puck based
Tests Available
in the U.S. (cont.):
Barbiturates (Urine) Barbiturates (Serum)
Benzodiazepines (Urine) Benzodiazepines (Serum)
Cannabinoids (THC) Cocaine Metabolite Ethanol
Methadone Methadone Metabolites Opiates
Phencyclidine Propoxyphene Salicylate Tricyclic
Antidepressants Ammonia Cholinesterase Manual
Pretreatment Hemoglobin A1c (HbA1c) Automated
Pretreatment Hemoglobin A1c (A1c) Microalbumin
Pancreatic Amylase Prealbumin Total Iron Binding
Capacity Carbamazepine Digoxin Gentamicin
Lithium Phenobarbital Phenytoin Theophylline
Tobramycin Valproic Acid Vancomycin
Number of Reagent
Containers Onboard/
Tests/Container:
Dependent on configuration
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/Tests
Assays:
Configuration dependent
System Liquid or Dry:
Average Length of
System Startup Time
and Daily Maintenance:
Liquid
Throughput:
Up to 1,800 tests per hour
Dependent on configuration
Time to First Result:
10 minutes
Sample Size:
2-30 µL per test; assay dependent
Contact:
Tim Keating
(302) 631-9482
timothy.m.keating@siemens.com
Frequency of
Calibration:
Up to 60 days
What differentiates your
product from others on
the market?
200 Basic Metabolic Panels per hour. Automatic
Sample Retain technology provides ability to
perform repeats, diluitions, and reflex testing
without retrieving the primary tube. Comprehensive
menu. Consistent cycle times. Point-in-space
aspiration offers connectivity to automation
track or rack handler without robotics or special
hardware. Stat sample prioritization. Direct
sampling from track prevents detaining tubes
at analyzer and reduces aliquoting. Robust
hardware and simplified software design, with
automatic calibration validation and tracking.
Unique no-maintenance oil bath. Sample integrity
checking, including serum indices, short sample
and clot detection, reduces manual intervention.
Offers integrated data management, open reagent
system, primary tube sampling, positive sample
ID and onboard dilution. Concentrated reagents
provide as many as 3,060 tests in a compact 40 or
70 mL container for maximum productivity.
Product:
VersaCell™ System
What differentiates
your product from
others on the market?
Multiple instrument configurations with small
footprint and flexible layouts. Processes multiple
tube sizes simultaneously. Tube centric sample
management prioritizes testing by tube rather than
by rack. No track is required for sample delivery. No
scheduled maintenance. Connected analyzers are
functionally independent allowing.
Product:
StreamLAB® Automation Solution
What differentiates
your product
from other products
on the market?
Simplifies sample management with an easy-touse, single operator interface for all sample input,
output and status monitoring. Routes individual stat
and routine samples to the appropriate analyzer,
optimizing throughput and turnaround time.
Completed tubes can be sorted and mapped into
output racks to enable easy storage, subsequent
testing or retrieval. The Workcell is capable of
running a wide range of sample tube sizes and
types simultaneously without pre-sorting. Multi-tube
carrier with RFID 2 chip for continuous, reliable
sample tracking. Refrigerated storage and retrieval
is also available.
Operational Type:
Continuous random access
Separation
Methodologies:
Latex agglutination/centrifugation
Sample Handling
System:
Onboard 84 position sample wheel, Universal
Rack Handler option with universal 5-position
rack, 425 total onboard capacity, continuous feed
capability, automation track connectivity with
unlimited samples
Number of Reagent
Containers Onboard/
Tests/Container:
55 tests onboard (including ISEs); test per kit varies
by assay
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
Automatic sample retain technology, auto-dilution,
auto-reflex testing, auto-repeat testing
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
5 minutes
Product:
ADVIA® 2400 Chemistry System
Methodologies Used:
Endpoint, rate reaction, 2-point rate, multi-point
homogeneous immunoassay
Tests Available
in the U.S.:
Acid Phosphatase Alanine Aminotransferase
Alanine Aminotransferase (P5P) Albumin Alkaline
Phosphatase (AMP) Alkaline Phosphatase (DEA)
Amylase Aspartate Aminotransferase Aspartate
Aminotransferase (P5P) Bilirubin, Direct Bilirubin,
Total Calcium (Arsenazo) Calcium (CPC) Carbon
Dioxide Chloride (ISE) Cholesterol Creatine Kinase
Creatinine (Jaffe) Creatinine (Enzymatic) Direct HDL
Cholesterol Direct LDL Cholesterol Gamma-
CHEMISTRY
Contact:
Eric LaFleche
(914) 524-3823
eric.lafleche@siemens.com
Product:
ADVIA® 1800 Chemistry System
Methodologies Used:
End-point, rate reaction, 2-point rate
Tests Available
in the U.S.:
Acid Phosphatase Alanine Aminotransferase
Alanine Aminotransferase (P5P) Albumin Alkaline
Phosphatase (AMP) Alkaline Phosphatase (DEA)
Amylase Aspartate Aminotransferase Aspartate
Aminotransferase (P5P) Bilirubin, Direct Bilirubin,
Total Calcium (Arsenazo) Calcium (CPC) Carbon
Dioxide Chloride (ISE) Cholesterol Creatine Kinase
Creatinine (Jaffe) Creatinine (Enzymatic) Direct
HDL Cholesterol Direct LDL Cholesterol GammaGlutamyltransferase (GGT) Glucose Hexokinase
Glucose Oxidase Inorganic Phosphorous Iron
Lactate Lactate Dehydrogenase (L-P) Lactate
Dehydrogenase (P-L) Lipase Magnesium
Potassium (ISE) Sodium (ISE) Total Protein Total
Protein - Urine/CSF Triglycerides Urea Nitrogen
Uric Acid Alpha-1 Antitrypsin Anti-Streptolysin O
Apolipoprotein A1 Apolipoprotein B Complement
3 (C3) Complement 4 (C4) C-Reactive Protein
(CRP) Wide Range C-Reactive Protein (wr-CRP)
Cardiophase® hsCRP Cystatin C Haptoglobin
Immunoglobulin A (IgA) Immunoglobulin G (IgG)
Immunoglobulin M (IgM) Rheumatoid Factor (RF)
Transferrin Acetaminophen Amphetamines
80 JULY 2010 • advance /Laboratory • www.advanceweb.com
Tests Available
in the U.S. (cont.):
Glutamyltransferase (GGT) Glucose Hexokinase
Glucose Oxidase Inorganic Phosphorous Iron
Lactate Lactate Dehydrogenase (L-P) Lactate
Dehydrogenase (P-L) Lipase Magnesium
Potassium (ISE) Sodium (ISE) Total Protein Total
Protein - Urine/CSF Triglycerides Urea Nitrogen
Uric Acid Alpha-1 Antitrypsin Anti-Streptolysin O
Apolipoprotein A1 Apolipoprotein B Complement
3 (C3) Complement 4 (C4) C-Reactive Protein
(CRP) Wide Range C-Reactive Protein (wr-CRP)
Cardiophase® hsCRP Cystatin C Haptoglobin
Immunoglobulin A (IgA) Immunoglobulin G (IgG)
Immunoglobulin M (IgM) Rheumatoid Factor
(RF) Transferrin Acetaminophen Amphetamines
Barbiturates (Urine) Barbiturates (Serum)
Benzodiazepines (Urine) Benzodiazepines
(Serum) Cannabinoids (THC) Cocaine Metabolite
Ethanol Methadone Methadone Metabolites
Opiates Phencyclidine Propoxyphene
Salicylate Tricyclic Antidepressants Ammonia
Cholinesterase Manual Pretreatment Hemoglobin
A1c (HbA1c) Automated Pretreatment
Hemoglobin A1c (A1c) Microalbumin Pancreatic
Amylase Prealbumin Total Iron Binding
Capacity Carbamazepine Digoxin Gentamicin
Lithium Phenobarbital Phenytoin Theophylline
Tobramycin Valproic Acid Vancomycin
COAGULATION
Contact:
Jackie Hauser
(847) 267-5383
jacqueline.k.hauser@siemens.com
Product:
BFT™ II Coagulation Analyzer
Methodologies Used:
Turbido-densitometric system for clotting assays
Tests Available in the
U.S.:
PT, APTT, Fibrinogen
Throughput:
N/A, manual system
Time to First Result:
Assay dependent
Sample Size:
50 μL
Frequency of
Calibration:
Assay dependent. CLIA guidelines recommend
calibration at least once every six months. More
frequent calibration may be required if QC is
outside of the acceptable range or as dictated by
local regulations.
What differentiates your
product from others on
the market?
Unique turbo-densitometric detector tests lipemic
and icterica samples accurately, built-in printer and
INR printouts for ease of use. Open reagent system.
Operational Type:
Manual
Sample Handling
System:
Manual
Number of Reagent
Containers Onboard/
Tests/Container:
4 containers/tests vary
Throughput:
Up to 2,400 tests per hour
Time to First Result:
10 minutes
Sample Size:
2-30 µL; assay dependent
Frequency of
Calibration:
Up to 60 days
Reagents Refrigerated
Onboard:
No
What differentiates
your product from
others on the market?
A rapid 2-second probe cycle time maximizes
tube speed and test throughput. Automatic
Sample Retain technology, auto-repeat, autodilution and auto-reflex testing. Point-in-space
aspiration offers connectivity to track or rack
handler without robotics or special hardware.
STAT sample prioritization. Direct sampling from
track prevents detaining tubes at analyzer and
reduces aliquoting. Sample integrity check for
icterus, hemolysis and lipemia. Sample probe
with automatic clot/clog detection, liquid level
sensing, short sample detection and crash
protection. Advances in reagent onboard
stability, calibration frequency, interference
reduction and linearity expansion. Offers
integrated data management, open reagent
system, primary tube sampling, positive sample
ID and onboard dilution. Concentrated reagents
provide as many as 3,060 tests in a compact 40
or 70 mL container.
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance 1 minute
Product:
Sysmex® CA-530 Coagulation Analyzer
Methodologies Used:
Optical based system. Clotting and chromogenic
methodologies used.
Tests Available in the
U.S.:
PT, APTT, Fibrinogen, TT, Factor Assays, Reptilase
time, Protein C clot, AT III, Protein C chromo,
Heparin
Throughput:
54 PT tests/hour, 43 PT/APTT tests/hour
Time to First Result:
7 minutes
Sample Size:
50 μL PT
Frequency of
Calibration:
Assay dependent. CLIA guidelines recommend
calibration at least once every six months. More
frequent calibration may be required if QC is
outside of the acceptable range or as dictated by
local regulations.
What differentiates your
product from others on
the market?
Smallest footprint in class, low operating
expense, 5-parameter true random access with
clotting/chomogenic capabilities; integrated data
management, open reagent system, primary tube
sampling, onboard dilution.
Operational Type:
Continuous random access
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
11 containers/tests vary
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/Tests
Assays:
10 specimens/assays vary
System Liquid or Dry:
Liquid
Operational Type:
Continuous random access
Separation
Methodologies:
Latex agglutination/centrifugation
Sample Handling
System:
Onboard 84 position sample wheel, Universal
Rack Handler option with universal 5-position
rack, 425 total onboard capacity, continuous feed
capability, automation track connectivity with
unlimited samples.
Number of Reagent
Containers Onboard/
Tests/Container:
49 tests onboard (including ISEs); tests per kit
varies by assay
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
Automatic sample retain technology, auto-dilution,
auto-reflex testing, auto-repeat testing
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
5 minutes
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81
Laboratory Analyzers buyers guide
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <5 minutes
Product:
Sysmex CA-560 Coagulation Analyzer
Methodologies Used:
Optical based system. Clotting, chromogenic and
immunologic methodologies used.
Tests Available
in the U.S.:
PT, APTT, Fibrinogen, TT, Factor Assays, Reptilase
time, Protein C clot, AT III, Protein C chromo,
Heparin, D-Dimer
Throughput:
54 PT tests/hour, 43 PT/APTT tests/hour
Time to First Result:
7 minutes
®
Number of Reagent
Containers Onboard/
Tests/Container:
39 containers/tests vary
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
50 specimens/assays vary
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <5 minutes
Sample Size:
50 μL
Product:
Sysmex® CA-7000 Coagulation Analyzer
Frequency of
Calibration:
Assay dependent. CLIA guidelines recommend
calibration at least once every six months. More
frequent calibration may be required if QC is
outside of the acceptable range or as dictated by
local regulations.
Methodologies Used:
Optical based system. Clotting, chromogenic and
immunologic methodologies used.
Tests Available
in the U.S.:
PT, APTT, Fibrinogen, TT, Reptilase time, Factor
Assays, drVVt screen and confirm, Factor V
Leiden, Protein C clot, Protein S activity, AT
III, Plasminogen, Factor VIII chromo, Alpha-2
Antiplasmin, Protein C chromo, Heparin, D-dimer
What differentiates
your product from
others on the market?
Smallest footprint in its class; onboard quality
control package; primary tube sampling; integrated
data management; positive sample ID; onboard
dilution, specialty assay capability
Throughput:
280 PT tests/hour, 480 PT/APTT tests/hour
Operational Type:
Continuous random access
Time to First Result:
7 minutes
Sample Handling
System:
Rack
Sample Size:
50 μL
Number of Reagent
Containers Onboard/
Tests/Container:
11 containers/tests vary
Frequency of
Calibration:
Reagents Refrigerated
Onboard:
Yes
Assay dependent. CLIA guidelines recommend
calibration at least once every six months. More
frequent calibration may be required if QC is
outside of the acceptable range or as dictated by
local regulations.
Walkaway Capacity
in Specimen/
Tests Assays:
10 specimens/assays vary
What differentiates
your product from
others on the market?
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <5 minutes
Fastest throughput available for routine testing;
robust 2nd generation cap-piecing; PT, APTT
results every 7 seconds; continuous loading of
reagents, consumables and patient samples
without interruption; integrated data management;
primary tube sampling with cap piercing standard;
positive sample ID; onboard dilution.
Operational Type:
Continuous random access
Sample Handling
System:
Rack
Product:
Sysmex® CA-1500 Coagulation Analyzer
Optical based system. Clotting, chromogenic and
immunologic methodologies used.
Number of Reagent
Containers Onboard/
Tests/Container:
58 containers/tests vary
Methodologies Used:
Tests Available
in the U.S.:
PT, APTT, Fibrinogen, TT, Reptilase time,
Factor Assays, drVVt screen and confirm,
Factor V Leiden, Protein C clot, Protein S
activity, AT III, Plasminogen, Factor VIII chromo,
Alpha-2 Antiplasmin, Protein C chromo,
Heparin, D-dimer
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
In Specimen/
Tests Assays:
100 specimens/assays vary
System Liquid or Dry:
Liquid
Throughput:
120 PT tests/hour, 80 PT/APTT tests/hour
7 minutes
Sample Size:
50 μL
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <5 minutes
Time to First Result:
Frequency of
Calibration:
Assay dependent. CLIA guidelines recommend
calibration at least once every six months. More
frequent calibration may be required if QC is
outside of the acceptable range or as dictated by
local regulations.
Product:
BCS® XP System
Methodologies Used:
Optical based system. Clotting, chromogenic and
immunologic methodologies used.
Tests Available
in the U.S.:
PT, APTT, Fibrinogen, TT, Reptilase time, Factor
Assays, drVVt screen and confirm, Factor V
Leiden, Protein C clot, Protein S activity, AT
III, Plasminogen, Factor VIII chromo, Alpha-2
Antiplasmin, Protein C chromo, Heparin, D-dimer,
BC von Willebrand-risto. Cofactor assay.
Throughput:
380 PT tests/hour, 325 PT/APTT tests/hour
Time to First Result:
<5 minutes
Sample Size:
50 μL
What differentiates
your product from
others on the market?
Simultaneous curve calibration and patient
testing; robust 2nd generation cap-piecing;
ability to load multiple bottles or multiple lots of
reagent; integrated data management; primary
tube sampling with cap piercing optional; positive
sample ID; onboard dilution
Operational Type:
Continuous random access
Sample Handling
System:
Rack
82 JULY 2010 • advance /Laboratory • www.advanceweb.com
Frequency of
Calibration:
Assay dependent. CLIA guidelines recommend
calibration at least once every six months. More
frequent calibration may be required if QC is
outside of the acceptable range or as dictated by
local regulations.
What differentiates
your product from
others on the market?
User-definable calibration curve expiration and
pre-warning alerts; user-definable barcode utility
enables customizable reagent protocols; userfriendly Windows XP software; integrated data
management; primary tube sampling; positive
sample ID; onboard dilution
Operational Type:
Continuous random access
Separation
Methodologies:
Bead/centrifugation
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
12 reagents onboard; tests per container varies
with assay
Reagents Refrigerated
Onboard:
No; cooled area.
Operational Type:
Continuous random access
Sample Handling
System:
Rack
Walkaway Capacity
In Specimen/
Tests Assays:
Up to 100 tests
Number of Reagent
Containers Onboard/
Tests/Container:
90 containers/tests vary
System Liquid or Dry:
Liquid
5 minutes startup, daily maintenance ~15 minutes
Reagents Refrigerated
Onboard:
Yes
Average Length of
System Startup Time
and Daily Maintenance:
Walkaway Capacity
in Specimen/
Tests Assays:
100 specimens/assays vary
Product:
IMMULITE® 2000 Immunoassay System
Methodologies Used:
Enzyme-enhanced chemiluminescence
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Daily maintenance <5 minutes
Tests Available
in the U.S.:
3gAllergy™ Specific IgE, ACTH, AFP,
Androstenedione, Anti-HBc IgM, Anti-HBc Total,
Anti-HBs, Anti-TG Ab, Anti-TPO Ab, Beta-2
Microglobulin, BR-MA (CA 15-3), Calcitonin, Canine
TLI, Canine Total T4, Canine TSH, Carbamazepine,
CEA, CKMB, Cortisol, C-Peptide, DHEA-SO4,
Digitoxin, Digoxin, EPO, Estradiol, Ferritin, Folic
Acid, Free PSA, Free T3, Free T4, FSH, Gastrin,
Growth Hormone (hGH), H. pylori IgG, HBsAg,
HBsAg confirmatory, HCG, Herpes I & II IgG, High
Sensitivity CRP, Homocysteine, IGFBP-3, IGF-I,
Insulin, Intact PTH, LH, Microalbumin (urine) (ALB),
Myoglobin, OM-MA (CA 125), PAP, Phenobarbital,
Phenytoin, Progesterone, Prolactin, PSA,
PYRILINKS-D, Rapid TSH, RBC Folate, Rubella
IgM, Rubella , Quantitative IgG, SHBG, TBG,
Syphilis, Theophylline, Third Generation PSA, Third
Generation TSH, Thyroglobulin, Thyroid Uptake,
Total IgE, Total T3, Total T4, Total Testosterone,
Toxoplasma IgM, Toxoplasma Quant. IgG, Troponin
I, Unconjugated Estriol, Valproic Acid, Vitamin B12
IMMUNOASSAY
Contact:
Martu Richards
(914) 524-3828
martu.richards@siemens.com
Product:
IMMULITE® 1000 Immunoassay System
Methodologies Used:
Enzyme enhanced chemiluminescence
Tests Available
in the U.S.:
ACTH, AFP, Androstenedione, Anti-HBc IgM,
Anti-HBc Total, Anti-HBs, Anti-TG Ab, Anti-TPO
Ab, Beta-2 Microglobulin, BR-MA (CA 15-3),
Calcitonin, Canine TLI, Canine Total T4, Canine TSH,
Carbamazepine, CEA, CKMB, Cortisol, C-Peptide,
DHEA-SO4, Digoxin, EPO, Estradiol, Ferritin, Folic
Acid, Free PSA, Free T3, Free T4, FSH, Gastrin,
Growth Hormone (hGH), H. pylori IgG, HBs Ag,
HBs Ag confirmatory, HCG, Herpes I & II IgG, High
Sensitivity CRP, Homocysteine, IGFBP-3, IGF-I,
Insulin, Intact PTH, LH, Microalbumin (urine) (ALB),
Myoglobin, OM-MA (CA 125), PAP, Phenobarbital,
Phenytoin, Progesterone, Prolactin, PSA,
PYRILINKS-D, Rapid TSH, RBC Folate, Rubella IgM,
Rubella Quantitative IgG, SHBG, TBG, Theophylline,
Third Generation PSA, Third Generation TSH,
Thyroglobulin, Thyroid Uptake, Total IgE, Total T3,
Total T4, Total Testosterone, Toxoplasma Quant.
IgG, Troponin I, Turbo CKMB, Turbo HCG, Turbo
Intact PTH, Turbo Myoglobin, Turbo Troponin I,
Unconjugated Estriol, Valproic Acid, Vitamin B12
*Under Development, not available for sale: Canine
FT4*, CMV IgM*, D-Dimer*,EBV NA IgG*, EBV VCA
IgG*, EBV VCA IgM*,aToxoplasma IgM*
Throughput:
Up to 120 tests/hour
Time to First Result:
15 (Turbo assays); 42-65 minutes (assay
dependent)
Sample Size:
Assay dependent
Frequency of
Calibration:
Assay dependent, mostly 2-4 weeks
What differentiates
your product from
others on the market?
Routine, esoteric and allergy testing. Samples
can be continuously processed for improved
turnaround times. Stat samples easily added.
Remote Diagnostics provides customers with
enhanced support and troubleshooting assistance
that can reduce downtime. Offers integrated data
management and onboard dilution.
*Under Development, not available for sale:
Canine FT4*, CMV IgM* , D-Dimer*, EBV NA IgG*,
EBV VCA IgG*, EBV VCA IgM*, HBsAbQuant*,
Toxoplasma IgM*
Throughput:
Up to 200 tests/hour
Time to First Result:
35 minutes (assay dependent)
Sample Size:
Assay dependent
Frequency of
Calibration:
1-4 weeks, assay dependent
What differentiates
your product from
others on the market?
Routine, esoteric and allergy testing; proprietary
wash technique for high sensitivity third-generation
assays; no detectable carryover; proactive technical
support through RealTime Solutions; integrated
data management, primary tube sampling, positive
sample ID, proprietary onboard dilution and up to 5
hours of usable walkaway time.
Operational Type:
Continuous random access
Separation
Methodologies:
Bead/centrifugation
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
24 reagents onboard; 200 tests per kit
Reagents Refrigerated
Onboard:
Yes
www.advanceweb.com • advance /Laboratory • JULY 2010
83
Laboratory Analyzers buyers guide
Walkaway Capacity
in Specimen/
Tests Assays:
1,000 tests
Methodologies Used:
Direct Chemiluminescence
Tests Available
in the U.S.:
Cortisol (Urine, Serum), Cortisol (Urine) Cortisol
(Serum), Total IgE, Ferritin, RBC Folate, Folic Acid/
Folate, VB12, Homocysteine, Myoglobin, TnIUltra, BNP, CK-MB, Insulin, C-Peptide (Serum),
C-Peptide (Urine), HAV-IgM, Carbamazepine,
Digoxin, Gentamicin, Theophylline, Tobramycin,
Valproic Acid, Vancomycin, AFP, CA 15-3, CEA,
PSA, Complexed PSA, BR 27-29, CA125II, CA199, free T4, free T3, iPTH, T3, T4, TSH, TSH-3,
T-Uptake, Estradiol-6 III, FSH, HCG (Total HCG),
LH, Progesterone, Prolactin, Total Testosterone
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
4 minutes startup; daily maintenance 15 minutes
Product:
IMMULITE® 2500 Immunoassay System
Methodologies Used:
Enzyme-enhanced chemiluminescence
Tests Available
in the U.S.:
3gAllergy™ Specific IgE, ACTH, AFP,
Androstenedione, Anti-TG Ab, Anti-TPO Ab, Beta2 Microglobulin, BR-MA (CA15-3), Calcitonin,
Carbamazepine, CEA, CKMB, CMV IgG, Cortisol,
C-Peptide, DHEA-SO4, Digoxin, EPO, Estradiol,
Ferritin, Folic Acid, Free T3, Free T4, FSH,
Gastrin, Growth Hormone (hGH), H. pylori IgG,
HCG, Herpes I & II IgG, High Sensitivity CRP,
Homocysteine, IGFBP-3, IGF-I, Insulin, Intact PTH,
LH, Microalbumin (urine) (ALB), Myoglobin, OM-MA
(CA125), Phenobarbital, Phenytoin, Progesterone,
Prolactin, PSA, PYRILINKS-D, Rapid TSH, RBC
Folate, Rubella IgM, Rubella Quantitative IgG,
SHBG, TBG, Theophylline, Third Generation
PSA, Third Generation TSH, Thyroglobulin,
Thyroid Uptake, Total IgE, Total T3, Total T4, Total
Testosterone, Toxoplasma IgM, Toxoplasma Quant.
IgG, Troponin I, Turbo CKMB, Turbo Intact PTH,
Turbo Myoglobin, Turbo Troponin I, Unconjugated
Estriol, Valproic Acid, Vitamin B12.
Throughput:
Up to 180 tests per hour in random access or batch
Time to First Result:
15 minutes
Sample Size:
Varies by test
Frequency of
Calibration:
Assay dependent, 3-28 days
What differentiates
your product from
others on the market?
Optimal productivity, speed and efficiency and
the power to process up to 180 tests per hour;
15 refrigerated onboard reagents, 84 sample
onboard capacity, and no pause loading/unloading
of samples, reagents and consumables. Offers
integrated data management, primary tube
sampling, positive sample ID and onboard dilution.
Operational Type:
Random access
Separation
Methodologies:
Magnetic particle
Sample Handling
System:
Rack
*Under Development, not available for sale: none
15 reagents with 50-200 tests per container (assay
dependent)
Throughput:
Up to 200 tests/hour
Number of Reagent
Containers Onboard/
Tests/Container:
Time to First Result:
15 minutes (stat assays); 35-65 minutes (routine,
assay dependent)
Reagents Refrigerated
Onboard:
Sample Size:
5 µL
Frequency of
Calibration:
1-4 weeks, assay dependent
Refrigerated reagents with barcode identification,
automatic inventory tracking and flagging,
calibration validity tracked and flagged, reagent
on board residency tracked and flagged, reagent
expired/low flags.
What differentiates
your product from
others on the market?
Routine, esoteric and allergy testing; proprietary
wash technique for high sensitivity thirdgeneration assays; no detectable carryover;
technical support through RealTime Solutions; stat
testing; integrated data management; primary tube
sampling; positive sample ID; proprietary onboard
dilution; up to 5 hours of usable walkaway time.
Walkaway Capacity
in Specimen/
Tests Assays:
400 tests
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
No daily startup; 15 minutes daily maintenance
Product:
ADVIA Centaur® XP Immunoassay System
Methodologies Used:
Direct chemiluminescence
Tests Available
in the U.S.:
Total IgE, Ferritin, RBC Folate, Folic Acid/Folate,
Vitamin B12, BNP, CK-MB, Homocysteine,
Myoglobin, TnI- Ultra, C-Peptide (Serum),
C-Peptide (Urine), Insulin, HAV Total, HAV IgM,
HBc Total, HBc IgM, Anti-HBs, HBsAg, HBsAg
Confirmatory, HCV, HIV Enhanced (1/O/2), Rubella
IgG, Rubella IgM, Toxoplasma IgG, Toxoplasma
IgM, Cortisol (Urine), Cortisol (Serum), AFP,
Estradiol-6, Estradiol-6 III, FSH, HCG (Total HCG),
LH, Progesterone, Prolactin,, Total Testosterone,
Carbamazepine, Digitoxin, Digoxin, Gentamicin,
Phenobarbital, Phenytoin, Theophylline,
Tobramycin, Valproic Acid, Vancomycin, Free T3,
Total T3, Free T4, Total T4, Intact PTH, Anti-TG,
Anti-TPO, Thyroid Uptake, TSH, Third Generation
TSH, BR27-29, CEA, CA15-3, CA125II, CA19-9,
Her-2/neu, PSA, Complexed PSA
Operational Type:
Continuous random access
Separation
Methodologies:
Bead/centrifugation
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
24 reagents onboard; 200 tests per kit
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/Tests
Assays:
1,000 test walkaway capacity; 5 hours of usable
walkaway time
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
4 minutes daily startup; daily maintenance
~15 minutes
Contact:
Louise Chang
(310) 645-8200 x7035
louise.chang@siemens.com
Throughput:
Up to 240 tests/hour
Time to First Result:
18 minutes, then every 15 seconds thereafter
ADVIA Centaur® CP Immunoassay System
Sample Size:
10 µL to 200 µL; assay dependent
Product:
84 JULY 2010 • advance /Laboratory • www.advanceweb.com
Frequency of
Calibration:
Assay dependent, 7-42 days; most assays
are 28 days
What differentiates
your product from
others on the market?
Analyzer integrates homogeneous LOCI and
heterogeneous immunoassays onboard with
other chemistries; allows a single platform
for over 95 percent of most requested tests;
eliminates sample splitting between general
chemistry tests and immunoassays; integration
of Lean design concepts with no specimen pretreatment or reagent preparation by the operator;
fully automated onboard ISD assays. Offers
integrated data management, open reagent
system, primary tube sampling, positive sample
ID and onboard dilution
Other Utility
Requirement:
Deionized water
What differentiates
your product from
others on the market?
Comprehensive disease state menu including HIV;
disposable pipette tips that eliminate sampleto-sample carryover, automatic dilution, repeat
and reflex testing; Smart Algorithm Software
automatically repeats and confirms reactive
infectious disease tests. Offers integrated data
management, primary tube sampling, positive
sample ID and onboard dilution.
Operational Type:
Continuous random access
Separation
Methodologies:
Magnetic particle
Other utility
requirement:
Deionized water NCCLS Type 2
Operational Type:
Batch, random access, continuous random access
Sample Handling
System:
5 position universal rack
Separation
Methodologies:
Magnetic particle; all LOCI and EMIT methods are
homogenous
Number of Reagent
Containers Onboard/
Tests/Container:
30 refrigerated onboard reagents; 50-200 tests/kit
(assay dependent)
Sample Handling
System:
Segmented sample wheel
Yes
Number of Reagent
Containers Onboard/
Tests/Container:
91/15-360
Reagents Refrigerated
Onboard:
Walkaway Capacity
in Specimen/
Tests Assays:
840 test walkaway capacity
Reagents Refrigerated
Onboard:
Yes
Liquid, ready to use
Average Length of
System Startup Time
and Daily Maintenance:
No daily start-up; automated daily maintenance is
40 minutes with 5 minutes of hands-on time
Walkaway Capacity
in Specimen/
Tests Assays:
60 specimens / 6,000 tests
System Liquid or Dry:
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
System startup not required. Daily maintenance is
<5 minutes.
Product:
Dimension® RxL Max® w/HM Integrated Chemistry
Analyzer
Methodologies Used:
Photometry, potentiometry, ACMIA, EMIT®, PETINIA
Tests Available
in the U.S.:
Acid Phosphatase, Albumin, Alcohol, Alkaline
Phosphatase, Ammonia, Amphetamines DAT,
Automated LDL, Acetaminophen, Amylase,
Automated HDL, Barbiturate DAT, Benzodiazepine
DAT, Blood Urea Nitrogen, C-Reactive Protein,
C3, C4, Calcium, Carbamazepine, CardioPhase
hsCRP Flex, CRP, Cholesterol, Cocaine DAT,
Creatine Kinase MB , Creatine Kinase Revised,
Creatinine, Cyclosporine, Cyclosporine A
Extended Range, Digotoxin, Digoxin, Direct
Bilirubin, Ecstasy, Enzymatic Carbonate, Ferritin,
Free PSA, Free T4, Glucose ,GGT, GOT/AST,
GPT/ALT, Gentamicin, HCG, Hemoglobin A1C
Kit, IBCT (No-pre-treat), IgA, IgG, IgM, Iron,
NT-proBNP, Lactate Dehydrogenase, Lactic Acid,
Lidocaine, Lipase, Lithium, Microalbumin, MMB,
Magnesium, Methadone DAT, Myeloperoxidase,
Myoglobin, NAPA, Opiate DAT, Phencyclidine
DAT, Phenobarbital, Phenytoin, Phosphorus,
Prealbumin, Procainamide, Propoxyphene
DAT, Pseudocholinesterase, Salicylate, Serum
Barbiturates, Serum Benzodiazepines, Serum
Tricyclic Antidepressants, Sirolimus, THC DAT,
TPSA, TSH, Tacrolimus, Theophylline, Thyronine
Uptake, Thyroxine, Tobramycin, Total Bilirubin,
Total Iron Binding Capacity, Total Protein, Total
T3, Transferrin, Triglycerides, Troponin I, Uric Acid,
Urine CFP, Valproic Acid, Vancomycin
Throughput:
800 tests/hour photometric and potentiometric, 167
heterogeneous immunoassay tests/hour
INTEGRATED SYSTEMS
Contact:
Christina Tassone
847-236-7222
christina.tassone@siemens.com
Product:
Dimension® EXL™ with LOCI® Module Integrated
Chemistry Analyzer
Methodologies Used:
LOCI®, ACMIA, EMIT®, PETINIA, photometry,
potentiometry
Tests Available
in the U.S.:
Acid Phosphatase, Albumin, Alcohol, Alkaline
Phosphatase, Ammonia, Amphetamines DAT,
Automated LDL, Acetaminophen, Amylase,
Automated HDL, Barbiturate DAT, Benzodiazepine
DAT, Blood Urea Nitrogen, C-Reactive Protein, C3,
C4, Calcium, Carbamazepine, CardioPhase hsCRP
Flex, CRP, Cholesterol, Cocaine DAT, Creatine
Kinase MB, Creatine Kinase Revised, Creatinine,
Cyclosporine, Cyclosporine A Extended Range,
Digotoxin, Digoxin, Direct Bilirubin, Ecstasy, Enzymatic
Carbonate, Ferritin, Free PSA, Glucose ,GGT, GOT/
AST, GPT/ALT, Gentamicin, HCG, Hemoglobin
A1C Kit, IBCT (No-pre-treat), IgA, IgG, IgM, Iron,
LOCI FT4, LOCI NT-proBNP, LOCI TSH, LOCI
Troponin I, Lactate Dehydrogenase, Lactic Acid,
Lidocaine, Lipase, Lithium, Microalbumin, MMB,
Magnesium, Methadone DAT, Myoglobin, NAPA,
Opiate DAT, Phencyclidine DAT, Phenobarbital,
Phenytoin, Phosphorus, Prealbumin, Procainamide,
Propoxyphene DAT, Pseudocholinesterase, Salicylate,
Serum Barbiturates, Serum Benzodiazepines,
Serum Tricyclic Antidepressants, Sirolimus, THC
DAT, TPSA, Tacrolimus, Theophylline, Thyronine
Uptake, Thyroxine, Tobramycin, Total Bilirubin, Total
Iron Binding Capacity, Total Protein, Transferrin,
Triglycerides, Uric Acid, Urine CFP, Valproic
Acid, Vancomycin
Throughput:
624 tests/hour
Time to First Result:
<60 seconds
Time to First Result:
36 seconds – 21 minutes
Sample Size:
5, 7 and 10 mL primary tubes
Sample Size:
5, 7 and 10 mL primary tubes, small sample cups
Frequency of
Calibration:
30-90 days
Frequency of
Calibration:
30-90 days
www.advanceweb.com • advance /Laboratory • JULY 2010
85
Laboratory Analyzers buyers guide
What differentiates
your product from
others on the market?
Integrates heterogeneous immunoassays onboard
with other chemistries; allows single platform
for over 95 percent of most requested tests;
eliminates sample splitting between general tests
and immunoassays; fully automated onboard ISD
assays. Offers integrated data management, open
reagent system, primary tube sampling, positive
sample ID and onboard dilution; integration of Lean
design concepts with no specimen pre-treatment or
reagent preparation by the operator.
Tests Available
in the U.S. (con.):
(MPA), Tacrolimus (no manual pretreatment),
Sirolimus, 1-Acid Glycoprotein (Orosomucoid),
Antistreptolysin, C3 Complement, C4 Complement,
C-Reactive Protein, C-Reactive Protein
Extended Range, Haptoglobin, Immunoglobulin
A, Immunoglobulin G, Immunoglobulin M,
Rheumatoid Factor, Transferrin, Ammonia,
Urine/Cerebrospinal Fluid, Protein, Lactic Acid,
Prealbumin, Human Chorionic Gonadotropin
Hormone, Ferritin, Total PSA, Free PSA
Operational Type:
Continuous random access
Throughput:
Separation
Methodologies:
EIA, latex particle turbidimetric, direct turbidimetric/
heterogeneous-magnetic particle, homogenous
(none)
437 photometric and potentiometric tests per hour,
167 heterogeneous IA tests per hour
Time to First Result:
60 seconds – 21 minutes
Sample Size:
5, 7 and 10 mL primary tubes and small sample
cups
Frequency of
Calibration:
30-90 days
What differentiates
your product from
others on the market?
Low-volume workstation that integrates
immunoassays onboard with other chemistries,
utilizes a single reagent format to meet over 95
percent of testing needs. Offers integrated data
management, open reagent system, primary
tube sampling, positive sample ID and onboard
dilution. Low volume reagent configuration option
available for Troponin I, NT-proBNP and HCG
assays. Integration of Lean design concepts with
no specimen pre-treatment or reagent preparation
by the operator, no sample splitting or aliquotting,
automated calibration and control processes, and
fully automated ISD assays onboard.
Other utility
requirement:
Deionized water NCCLS Type 2
Operational Type:
Continuous random access
Separation
Methodologies:
Heterogeneous-magnetic particle
Sample Handling
System:
Segmented sample wheel with rack system
Number of Reagent
Containers Onboard/
Tests/Container:
47/15-360
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
60 / 6,000
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
No routine startup, 10 minutes daily maintenance
with 5 minutes hands-on time
Contact:
Colleen Grier
(302) 631-8773
colleen.m.grier@siemens.com
Product:
Dimension Vista® 1500 and 3000T Intelligent Lab
System
Methodologies Used:
LOCI® Advanced Chemiluminescence, photometry,
nephelometry, EMIT® technology, heterogeneous
immunoassay (ACMIA, PETINIA, PETIA),
turbidimetric, V-LYTE® multisensor - potentiometry
Tests Available
in the U.S.:
a1Acid Glycoprotein (Orosomucoid), a1Antitrypsin,
a1Microglobulin, Acetaminophen, Alanine
Transaminase, Albumin, Alkaline Phosphatase,
Ammonia, Amylase, Antistreptolysin O,
Apolipoprotein A1, Apolipoprotein B, Aspartate
Transaminase, ß2Microglobulin, Blood Urea
Nitrogen, C Reactive Protein, C3 Complement, C4
Complement, Calcium, Carbamazepine, Carbon
Dioxide, Ceruloplasmin, Chloride, Cholesterol,
Creatine Kinase, Creatine Kinase MB Isoenzyme,
Sample Handling
System:
Segmented sample wheel with rack system
Number of Reagent
Containers Onboard/
Tests/Container:
47 reagents, 91 reagents with optional reagent
management system/15-360
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
60 specimens / 6,000 tests
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
System startup not required. Daily maintenance is
<5 minutes.
Contact:
Jason F. Ong
(847) 236-7328
jason.f.ong@siemens.com
Product:
Dimension® Xpand® Plus Integrated Chemistry
Analyzer
Methodologies Used:
Photometry, potentiometry, ACMIA, EMIT®, PETINIA
Tests Available
in the U.S.:
Albumin, Calcium, Creatinine, Creatinine
Enzymatic, Direct Bilirubin, Iron, Magnesium,
Phosphorus, Total Bilirubin, , Total Iron-Binding
Capacity (no manual pretreatment), Total Protein,
Urea Nitrogen, Uric Acid, Enzymatic Carbon
Dioxide (CO2), Chloride, Potassium, Sodium,
Acid Phosphatase, Alanine Aminotransferase,
Aldolase1,3, Alkaline Phosphatase, Amylase,
Aspartate Aminotransferase, Creatine Kinase,
Creatine Kinase MB Isoenzyme, Dibucaine Number,
Glutamyl Transferase, Lactic Dehydrogenase,
Lipase, Pancreatic Amylase, Pseudocholinesterase,
Hemoglobin A1c (no manual pretreatment),
Glucose, Glucose from Hemolysate, Microalbumin,
Cardiac Troponin I, Mass CK-MB, Myoglobin,
NT-proBNP, Apolipoprotein A1 1, Apolipoprotein
B 1, CardioPhase® hsCRP, Cholesterol,
High Density Lipoprotein, Cholesterol, Low
Density Lipoprotein, Cholesterol, Lp(a)1,3,
Myeloperoxidase, Triglycerides, Thyroid Stimulating
Hormone, Thyronine Uptake, Total T3, Total
T4, Free T4, Urine Amphetamine Screen, Urine
Barbiturates Screen, Urine Benzodiazepines
Screen, Urine Cannabinoids Screen, Urine
Cocaine, Metabolite Screen, Urine Ecstasy, Urine
Methadone Screen, Urine Methaqualone Screen,
Urine Opiates Screen, Urine Phencyclidine, Urine
Propoxyphene Screen, Acetaminophen, Ethyl
Alcohol, Salicylate, Serum Barbiturates, Serum
Benzodiazepines, Serum Tricyclic, Antidepressants,
Gentamicin, Tobramycin, Vancomycin, Digoxin,
Digitoxin, N-Acetylprocainamide (NAPA),
Lidocaine, Procainamide, Carbamazepine,
Lithium, Phenobarbital, Phenytoin, Theophylline,
Valproic Acid, Cyclosporine (CsA C0) (no manual
pretreatment), Cyclosporine Extended Range, (CsA
C2) (no manual pretreatment), Mycophenolic Acid
86 JULY 2010 • advance /Laboratory • www.advanceweb.com
Tests Available
in the U.S. (con.):
Creatinine, Cyclosporine, Cyclosporine
–extended, Cystatin C, Digitoxin, Digoxin,
Direct Bilirubin, Ethyl Alcohol, Gamma Glutamyl
Transaminase, Gentamicin, Glucose, Haptoglobin,
Hemoglobin A1C, High Density Lipoprotein
Cholesterol, High Sensitivity CRP (CardioPhase®
hsCRP), Homocysteine, Immunoglobulin
E, Immunoglobulin A, Immunoglobulin G,
Immunoglobulin M, Iron, Lactate Dehydrogenase,
Lactic Acid, Lidocaine, Lipase, Lithium, LOCI
Beta Human Chorionic Gondatropin, LOCI Alpha
feto-protein, LOCI Carcinoembryonic Antigen,
LOCI Cardiac Troponin I, LOCI Ferritin, LOCI
Free Thyroxine, LOCI Free Triiodothyronine, LOCI
Mass Creatine Kinase MB Isoenzyme, LOCI
Myoglobin, LOCI N-terminal proBrain natriuretic
peptide, LOCI Thyroid Stimulating Hormone, Low
Density Lipoprotein Cholesterol, Magnesium,
Microalbumin, N-acetyl Procainamide,
Phenobarbital, Phenytoin, Phosphorus, Potassium,
Prealbumin (Transthyretin), Procainamide,
Pseudocholinesterase, Total Kappa Light
Chains,Total Lambda Light Chains, Specialty
albumin, Rheumatoid Factor, Serum Barbiturates*,
Serum Benzodiazepines*, Serum Salicylate,
Serum Tricyclic Antidepressants*, Sodium,
Soluble Transferrin Receptor, Theophylline,
Thyronine Uptake, Thyroxine, Tobramycin,
Total Bilirubin, Total Iron Binding Capacity, Total
Protein, Transferrin, Triglyceride, Triiodothyronine,
Uric Acid, Urinary/ Cerebrospinal Fluid Protein,
Urine Amphetamine, Urine Barbiturates, Urine
Benzodiazepines, Urine Cocaine, Urine Ecstasy,
Urine Methadone, Urine Methaqualone*, Urine
Opiate, Urine Phencyclidine, Urine Propoxyphene*
(*Syva®Emit® applications)
Throughput:
Up to 1,500 tests per hour for the Vista 1500 and up
to 3,000 test per hour for the Vista 3000T System
Time to First Result:
Varies by method: 22 seconds-21 minutes
Sample Size:
Method dependent (< 1-20 µL)
Frequency of
Calibration:
30-90 days–method dependent. Automatic
calibration for hands-off operation with method
specific user-selected criteria with calibration
materials stored onboard the system. Automatic
monitoring of calibration frequency.
What differentiates
your product from
others on the market?
Ultra-integrated system with 4 detectors
(including nephelometry and LOCI Advanced
chemiluminescence) for concurrent processing
of over 100 assays; continuous sample
loading of routine and stat specimens without
interruption. Onboard aliquot system for quick
return of primary specimen and automatic
onboard sample dilution/rerun capability.
Samples require no manual pretreatment
and reagents require no manual preparation.
Automatic Calibration & QC processing
with onboard calibrators and QC in vials.
Windows-based fully multitasking software
with online reference for training, maintenance
and troubleshooting; real-time system
monitoring for predictive, proactive service.
EasyLink® middleware system for result and
QC management, including autoverification of
patient results. Ability to “twin” systems (3000T)
to optimize workflow and turnaround time.
Ability to connect to StreamLAB® automation
system for pre-analytical sample processing.
Operational Type:
Continuous random access
Separation
Methodologies:
Homogeneous (none), magnetic particle.
Sample Handling
System:
Six position sample rack allows for intermix of
various tube types and cups. Onboard sample
aliquot used to automate specimen dilutions and
reruns. Priority loading for stat and whole blood
samples with dual clot check and level sense.
Number of Reagent
Containers Onboard/
Tests/Container:
Vista 1500 has 166 slots for reagents,
calibrators and/or QC materials. Vista 3000T
has double the capacity/ 20–1,200 tests per
Reagent Flex® cartridge.
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
200 sample tubes per hour with continuous
loading/Over 100 test methods/Over 20,000 tests.
Reagents can be loaded during operation.
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Daily 10-15 minutes, no weekly, monthly 20-30
minutes. Intelligent device management monitoring
through RealTime SolutionsSM for remote,
proactive predictions of maintenance needs.
Contact:
Pamela Curtin
914-524-3824
pamela.curtin@siemens.com
Product:
Dimension Vista® 500 and 1000T Intelligent Lab
System
Methodologies Used:
LOCI® Advanced Chemiluminescence,
photometry, nephelometry, EMIT® technology,
heterogeneous immunoassay (ACMIA,
PETINIA, PETIA), turbidimetric, V-LYTE®
multisensor - potentiometry
Tests Available
in the U.S.:
a1Acid Glycoprotein (Orosomucoid), a1Antitrypsin,
a1Microglobulin, Acetaminophen, Alanine
Transaminase, Albumin, Alkaline Phosphatase,
Ammonia, Amylase, Antistreptolysin O,
Apolipoprotein A1, Apolipoprotein B, Aspartate
Transaminase, ß2Microglobulin, Blood Urea
Nitrogen, C Reactive Protein, C3 Complement,
C4 Complement, Calcium, Carbamazepine,
Carbon Dioxide, Ceruloplasmin, Chloride,
Cholesterol, Creatine Kinase, Creatine Kinase MB
Isoenzyme, Creatinine, Cyclosporine, Cyclosporine
–extended, Cystatin C, Digitoxin, Digoxin,
Direct Bilirubin, Ethyl Alcohol, Gamma Glutamyl
Transaminase, Gentamicin, Glucose, Haptoglobin,
Hemoglobin A1C, High Density Lipoprotein
Cholesterol, High Sensitivity CRP (CardioPhase®
hsCRP), Homocysteine, Immunoglobulin
E, Immunoglobulin A, Immunoglobulin G,
Immunoglobulin M, Iron, Lactate Dehydrogenase,
Lactic Acid, Lidocaine, Lipase, Lithium, LOCI
Beta Human Chorionic Gondatropin, LOCI Alpha
feto-protein, LOCI Carcinoembryonic Antigen,
LOCI Cardiac Troponin I, LOCI Ferritin, LOCI
Free Thyroxine, LOCI Free Triiodothyronine, LOCI
Mass Creatine Kinase MB Isoenzyme, LOCI
Myoglobin, LOCI N-terminal proBrain natriuretic
peptide, LOCI Thyroid Stimulating Hormone, Low
Density Lipoprotein Cholesterol, Magnesium,
Microalbumin, N-acetyl Procainamide,
Phenobarbital, Phenytoin, Phosphorus, Potassium,
Prealbumin (Transthyretin), Procainamide,
Pseudocholinesterase, Total Kappa Light
Chains,Total Lambda Light Chains, Specialty
albumin, Rheumatoid Factor, Serum Barbiturates*,
Serum Benzodiazepines*, Serum Salicylate,
Serum Tricyclic Antidepressants*, Sodium,
Soluble Transferrin Receptor, Theophylline,
Thyronine Uptake, Thyroxine, Tobramycin,
Total Bilirubin, Total Iron Binding Capacity, Total
Protein, Transferrin, Triglyceride, Triiodothyronine,
Uric Acid, Urinary/ Cerebrospinal Fluid Protein,
Urine Amphetamine, Urine Barbiturates, Urine
Benzodiazepines, Urine Cocaine, Urine Ecstasy,
Urine Methadone, Urine Methaqualone*, Urine
Opiate, Urine Phencyclidine, Urine Propoxyphene*
(*Syva®Emit® applications)
www.advanceweb.com • advance /Laboratory • JULY 2010
87
Laboratory Analyzers buyers guide
Throughput:
Up to 1,000 tests per hour for the Vista 500 and up
to 2,000 test per hour for the Vista 1000T System
Time to First Result:
Varies by method: 22 seconds-21 minutes
Sample Size:
Method dependent (<1-20 µL)
Frequency of
Calibration:
30-90 days – method dependent. Automatic
calibration for hands-off operation with method
specific user-selected criteria with calibration
materials stored onboard the system. Automatic
monitoring of calibration frequency.
What differentiates
your product from
others on the market?
Ultra-integrated system with 4 detectors
(including nephelometry and LOCI Advanced
chemiluminescence) for concurrent processing of
over 100 assays; continuous sample loading of
routine and stat specimens without interruption.
Onboard aliquot system for quick return of
primary specimen and automatic onboard sample
dilution/rerun capability. Samples require no
manual pretreatment and reagents require no
manual preparation. Automatic Calibration & QC
processing with onboard calibrators and QC in
vials. Windows-based fully multitasking software
with online reference for training, maintenance and
troubleshooting; and real-time system monitoring
for predictive, proactive service. EasyLink®
middleware system for result and QC management,
including autoverification of patient results. Ability
to “twin” systems (1000T) to optimize workflow and
turnaround time.
Operational Type:
Continuous random access
Separation
Methodologies:
Homogeneous (none), magnetic particle
Sample Handling
System:
Six position sample rack allows for intermix of
various tube types and cups. Onboard sample
aliquot used to automate specimen dilutions and
reruns. Priority loading for stat and whole blood
samples with dual clot check and level sense.
Number of Reagent
Containers Onboard/
Tests/Container:
Vista 500 has 144 slots for reagents,
calibrators and/or QC materials. Vista 1000T
has double the capacity. 20-1,200 tests
per Reagent Flex® cartridge.
Reagents Refrigerated
Onboard:
Yes
Walkaway Capacity
in Specimen/
Tests Assays:
200 sample tubes per hour with continuous
loading/Over 100 test methods/Over 20,000 tests.
Reagents can be loaded during operation.
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Daily 10-15 minutes; monthly 20-30 minutes.
Intelligent device management monitoring through
RealTime SolutionsSM for remote, proactive
predictions of maintenance needs.
HEMATOLOGY
Contact:
Rita White
(302)631-7916
rita.f.white@siemens.com
Product:
ADVIA® 2120i Hematology System with Autoslide
Methodologies Used:
Cytochemistry, flow cytometry, laser light scatter
Tests Available
in the U.S.:
WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt,
CHCM, RDW, HDW, CH, CHDW, N#, N%, L#, L%,
M#, M%, E#, E%, B#, B%, LUC#, LUC%, Retic#,
Retic%, MCVr, CHCMr, CHr, RBC morphology
(NRBC, ANISO, MICRO, MACRO, HC VAR, HYPO,
HYPER, RBC Fragments, RBC Ghosts, Platelet
Clumps, Large Platelets) and WBC morphology
(Left Shift, Atypical Lymph, Blasts, Immature
Granulocytes, Myeloperoxidase Deficiency), CSF
WBC, CSF RBC, CSF PMN, CSF MN, CSF N# and
N%, CSF L# and L%, CSF M# and M%
88 JULY 2010 • advance /Laboratory • www.advanceweb.com
Throughput:
120 CBC samples per hour/74 retics per hour
Time to First Result:
2.5 minutes
Sample Size:
157 whole blood, 300 CSF
Frequency of
Calibration:
Minimum of every 6 months
What differentiates
your product from
others on the market?
Manual open-tube and closed-tube sampling;
small reagent consumption; flexible rack- based
autosampler; dual WBC methodology, dual
Hgb methodology, optional MultiSpecies test
selectivity software supports 23 species and
strains plus 30 user-definable species; CSF
assay performs automated RBC and WBC
differential; system integrates with ADVIA
Autoslide (sold separately).
Operational Type:
Continuous random access
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
Dependent on configuration
Reagents Refrigerated
Onboard:
No
Walkaway Capacity
in Specimen/
Tests Assays:
150 specimens/1,800 CBC/Automated Diffs
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Startup <2 minutes; daily wash cycles 6.5 minutes
each
Product:
ADVIA® 120 Hematology System
Methodologies Used:
Cytochemistry, flow cytometry, laser light scatter
Tests Available
in the U.S.:
WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt,
CHCM, RDW, HDW, CH, CHDW, N#, N%, L#, L%,
M#, M%, E#, E%, B#, B%, LUC#, LUC%, Retic#,
Retic%, MCVr, CHCMr, CHr, RBC morphology
(NRBC, ANISO, MICRO, MACRO, HC VAR, HYPO,
HYPER, RBC Fragments, RBC Ghosts, Platelet
Clumps, Large Platelets) and WBC morphology
(Left Shift, Atypical Lymph, Blasts, Immature
Granulocytes, Myeloperoxidase Deficiency), CSF
WBC, CSF RBC, CSF PMN, CSF MN, CSF N# and
N%, CSF L# and L%, CSF M# and M%
Throughput:
120 CBC samples per hour/74 retics per hour
Time to First Result:
2.5 minutes
Sample Size:
157 whole blood, 300 CSF
Frequency of
Calibration:
Minimum of every 6 months
What differentiates
your product from
others on the market?
Manual open-tube and closed-tube sampling;
small reagent consumption; flexible rack-based
autosampler; dual WBC methodology, dual
Hgb methodology, optional MultiSpecies test
selectivity software supports 23 species and
strains plus 30 user-definable species; CSF assay
performs automated RBC and WBC differential;
system integrates with ADVIA Autoslide (sold
separately).
Operational Type:
Continuous random access
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
Dependent on configuration
Reagents Refrigerated
Onboard:
No
Walkaway Capacity
in Specimen/
Tests Assays:
150 specimens/1,800 CBC/automated diffs
System Liquid or Dry:
Liquid
Average Length of
System Startup Time
and Daily Maintenance:
Startup <2 minutes; daily wash cycles 6.5 minutes
each
at worK, at HomE,
or on tHE go
URINALYSIS
Contact:
John Ebbs
(352) 242-8320
John.ebbs@siemens.com
Product:
CLINITEK® AUWi™ Automated Urinalysis System*,
CLINITEK Atlas® Automated Urine Chemistry
Analyzer *Only available in the U.S., Canada and
Puerto Rico.
ADVANCE E-nEwslEttErs
KEEp You InformEd!
E-newsletter subscribers get all these features,
every other week:
Methodologies Used:
Dry pad test measure, refractive index, fluorescent
flow cytometry, laser light scatter
Tests Available
in the U.S.:
Leukocyte Esterase, Nitrite, Occult Blood, Protein,
Glucose, Ketones, Urobilinogen, Bilirubin, pH,
Specific Gravity, Color, Clarity, WBC,
Tests Available
in the U.S. (cont.):
RBC, Epithelial Cells, Hyaline Casts, Bacteria,
Pathological casts, Crystals, Small Round Cells,
Sperm, Yeast
Throughput:
80 samples an hour on the AUWi, up to 225 an
hour on the stand alone Atlas
Time to First Result:
4 minutes on the AUWi, <1 minute on a standalone
Atlas
Sample Size:
4 mL on the AUWi, 2 mL on a standalone Atlas
Frequency of
Calibration:
Minimum of every 6 months
What differentiates
your product from
others on the market?
Streamlines workflow, unattended operation,
enhanced clinical results
Operational Type:
Continuous random access
Sample Handling
System:
Rack
Number of Reagent
Containers Onboard/
Tests/Container:
Dependent on configuration
Reagents Refrigerated
Onboard:
No
Walkaway Capacity
in Specimen/
Tests Assays:
100 specimens on the AUWi, 200 on the Atlas
System Liquid or Dry:
Liquid
Average Length of
Startup: <2 minutes; daily wash cycle: 10 minutes
each
System Startup Time
• Articles not available in print
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www.advanceweb.com • advance /Laboratory • JULY 2010
89
Go to www.advanceweb.com, select your magazine
and click the free e-newsletter signup link.
LABORATORY
TECHNOLOGY
Identifying Rare KRAS Mutations
By Julian Walker
RAS is an oncogene that has been implicated in the
development of various malignancies, most notably
colorectal cancer. This year’s annual meeting of the American
Association of Cancer Research (AACR) in Washington, DC,
featured several advancements in the field of oncology research,
including the Applied Biosystems® KRAS Mutation Analysis
Reagents from Life Technologies, a research-use-only* reagent set
delivering unambiguous detection of 12 common and rare KRAS
gene mutations, providing oncology researchers with sensitive and
comprehensive analysis of potential mutations. With the reagents,
oncology researchers have a sensitive/specific method to detect
the KRAS mutations with shifted term­­ination (ST) technology. ST is
a multi-cycle primer-extension method involving fluorescent
dye-labeled nucleotides for
detection of low-level somatic
Product Index
mutations. DNA isolated from
90Lab Technology:
clinical samples serves as a
Identifying Rare
template, and the bound
KRAS Mutations
primer is extended anywhere
92Lab Limelight: AP
from one to 20 labeled
Data Reporting
nucleotides (primer extension
96Case Study:
halts when a mutated base is
Challenges in Special
encountered). If a mutation is
Hemostasis Testing
present, the oligonucleotide
98 New Technology
product generated will differ in
length compared to the
wild-type fragment. These size differences can be observed using
capillary electrophoresis (CE) fragment analysis.
CE Fragment Analysis
Fragment analysis is a sizing assay performed on PCR amplicons generated from known hypervariable regions of genomic
DNA. Pooled PCR-generated fragments of various sizes are
separated by capillary electrophoresis using an Applied
Biosystems Genetic Analyzer. An internal lane size standard is
added to the PCR pool prior to capillary electrophoresis.
Applied Biosystems Data Collection Software generates a sizing
curve from the size standard fragments, thereby providing size
estimates for the fragments in the pooled sample. The presence
of mutations with single base pair resolution can be assigned
based on fragment size differences. GeneMapper® software*
provides analysis of the fragments.
Fragment analysis by capillary electrophoresis offers a number
90 JULY 2010 • advance /Laboratory • www.advanceweb.com
Table: FFPE CRC Study Results
Codon 12
mutation
Number of
Codon 13
occurrences mutation
Number of
occurrences
GGT>TGT
(G12C)
9
GGC>AGC
(G13S)
2
GGT>GTT
(G12V)
8
GGC>GAC
(G13D)
1
GGT>GAT
(G12D)
5
GGC>CGC
(G13R)
1
GGT>AGT
(G12S)
4
GGC>TGC
(G13C)
0
GGT>GCT
(G12A)
1
GGC>GCC
(G13A)
0
GGT>CGT
(G12R)
1
GGC>GTC
(G13V)
0
Total
28
4
of advantages for identifying mutations:
• Single-base resolution can be obtained on DNA fragments of up
to several hundred base pairs.
• High-throughput promotes greater lab productivity.
• Modern CE instrumentation is easy to operate and maintain.
• Because the signal is amplified in the assay, accurate results can
be obtained even with small amounts of starting material.
• Mutant identification is unambiguous.
KRAS Mutation Research
At AACR 2010, Life Technologies researchers presented data
documenting that the company’s KRAS reagent set accurately
identifies rare forms of KRAS mutations. In the study, 118
formalin-fixed paraffin-embedded (FFPE) colorectal cancer
(CRC) tissue samples, including 70 metastatic CRC samples,
were collected and analyzed (Table). Thirty-two samples were
found to carry a mutation across nine different variants. The
most common mutations were found in codon 12 across all six
possible variants, including two rare mutations at G12A and
G12R. Four mutations were found in codon 13 across three
variants. This included two rare G13S mutations and one rare
G13R mutation along with the more common G13D mutation. All
nine mutations were found in the metastatic samples. The study
demonstrated that Applied Biosystems' KRAS Mutation Analysis
Reagents, in conjunction with the company’s 3500 Capillary
Electrophoresis Genetic Analyzer, is an accurate and easy method
to identify and differentiate KRAS mutations. n
* KRAS Mutation Analysis Reagents, GeneMapper software and the
3500 Capillary Electrophoresis Genetic Analyzer are for Research Use Only.
Not intended for any human or animal therapeutic or diagnostic use.
Julian Walker is a senior product manager, Genetic Systems, Life
Technologies Corp., Foster City, CA.
Look fab in the lab with a
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lab limelight
AP Data Reporting
“When a patient gets registered in the laboratory information
system, it goes directly to the image management system,” Dr.
Tuthill says. Information and images move seamlessly between
the two systems.
By Jill Hoffman
Acquisition
mplementing an anatomic pathology (AP) solution that integrates
with a laboratory information system (LIS) can improve a
laboratory’s workflow and productivity. But connectivity should not
end here, as these technologies should be tied into other hospital
systems, says J. Mark Tuthill, MD, division head, Pathology
Informatics at Henry Ford Health System in Detroit.
Beginning in 2003, Dr. Tuthill and lab leaders implemented the
Sunquest CoPathPlus™ AP software integrated with the Sunquest
Laboratory™ Clinical Laboratory System and built applications
around the core systems. When lab officials sought barcodedriven surgical pathology, they worked with vendors to create a
custom solution that integrated into the AP system. The lab is also
implementing an image management solution for digital pathology
that interfaces to the LIS.

Whether a lab should implement a stand-alone AP system or one
integrated with the LIS boils down to lab volume. A small lab can
get away with a simple computer word processing system for
many processes, but a larger facility looking to mine data and
automate billing needs a dedicated LIS for anatomic pathology,
likely integrated with their clinical LIS.
Major considerations for choosing an AP system to integrate
with a LIS include vendor stability/support, core technology,
features/functionality, financial considerations (e.g., cost, license,
etc.) and scalability. One of the biggest mistakes people make is
to put too much emphasis on “bells and whistles.”
“If you make a good vendor partnership and you make good core
technology decisions, you’ll find that you’re able to achieve most of
the features and functions that you want,” Dr. Tuthill says.
related products
Orchard® Pathology
Orchard® Pathology is a comprehensive information system designed to meet the future trends in
pathology and handle the complexities of clinical, molecular and pathology testing and reporting. Orchard Pathology is a stand-alone system for anatomic and molecular or combined with Orchard®
Harvest™ Laboratory Information System (LIS) to integrate clinical. The shared database provides
access to the patient’s entire history and enables the consolidation of results from all departments on a
single report.
Sunquest CoPathPlus™
Sunquest CoPathPlus™ helps AP departments achieve workflow efficiencies, produce error-free reports and
capture/generate billing. Whatever the report format or level of sophistication—whether it includes images,
diagrams or data from speech recognition systems—the system customizes and shares information
produced by AP, cytology and cytogenetics departments. Healthcare providers can access multiple-sourced
data elements from automatic faxing, electronic transmission and electronic medical records. Comprehensive billing features include professional and technical charge capture interfaced to billing systems. Business
tools include QA data generation, management and regulatory reports.
Novovision NovoPath™
Novovision NovoPath™ produces personalized AP results reporting with customized reports. The software
is adaptable and has solutions supporting professional and technical split, dermatology, urology, GI,
cytology, hematology and more. The solution is configurable to a lab’s size and offers an expanding list of
result distribution options. Results can be released to an EMR or practice management system. Alternately,
they can be delivered via WAN or dial-up remote color printing, fax, e-mail, voice, FTP, HL7, XML, web,
SOAP or other electronic methods. Transcriptionists have found the system to be intuitive, requiring very
little training. Proprietary hardware is not necessary.
92 JULY 2010 • advance /Laboratory • www.advanceweb.com
Bio-Rad Laboratories
immunohematology
Bio-Rad brings its global expertise
in blood bank testing to the U.S.
You have a choice in blood bank testing backed by the quality
and support our customers have grown to count on
Biotest * + Bio-Rad
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• Combining blood bank expertise,
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For more information, contact your local Bio-Rad office
*BiotestDiagnosticsCorporationisaBio-Radcompany.
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LAB LIMELIGHT
Commission on Laboratory
Accreditation Laboratory General Checklist
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Does the paper or electronic requisition include all of the following
elements, as applicable?
❏ Adequate patient identification information (e.g., name,
registration number and location, or a unique confidential
specimen code if an alternative audit trail exists)
❏ Patient sex
❏ Patient date of birth or age
❏ Name and address (if different than the receiving laboratory) of
physician or legally authorized person ordering the test
❏ Tests requested
❏ Time and date of specimen collection when appropriate
❏ Source of specimen, when appropriate
❏ Clinical information, when appropriate
Dr. Tuthill recommends phasing in implementation for better
training and adoption.
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AL2010
Structured Reporting
As AP reporting communication has evolved from using mail to
electronic delivery, a unique set of transmission problems can
arise. Dr. Tuthill’s lab works daily with its health system’s
information technology (IT) team and AP vendor to monitor data
feeds and verify reports are going to the correct destination.
Clinical Laboratory Improvement Amendments ’88 offers
basic guidelines for reporting clinical and pathology results
(e.g., include patient name, birth date and medical record
number, etc.). Beyond this, labs must include the test performed
and relevant data elements—a more difficult task, since the
choice is subjective. Groups such as the American College of
Surgeons, the College of American Pathologists and the
Association of Pathology Chairs offer guidelines on elements to
include. “The other 30% really has to come from what your
customers need,” Dr. Tuthill says.
Once elements are decided upon, Dr. Tuthill recommends using
templates to maintain uniformity. The LIS offers support, as it is
sophisticated enough to intelligently sort and organize data.
Quality Assurance
Report quality assurance boils down to details—specifically
maintaining LIS nomenclatures. Labs must name elements for
easy user recovery. Subject matter experts annually review the
15-20 dictionaries at Dr. Tuthill’s lab. A Clinical Content Review
Committee also updates content on an as-needed basis.
“The outcome is that when a surgeon looks at our report for a
gallbladder across 10 different hospitals, they see the same data
elements, the same organization,” Dr. Tuthill says. “All that
changes are the particulars for a case. It allows us to focus on
unique elements as opposed to the structural elements that
surround the information.” n
Jill Hoffman is a senior associate editor.
94 JULY 2010 • advance /Laboratory • www.advanceweb.com
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Case Study
hallenges in Special
C
Hemostasis Testing
By William Luper, MD
nown throughout the greater Houston area as a center for
special hemostasis testing, the laboratory at Spring Branch
Medical Center was struggling under an increasing workload. As
outreach testing volume steadily increased, officials knew it was
time to simplify processes. They focused on two key areas:
instrument automation and assay automation.
The laboratory staff needed an instrument that was fast
and more automated. And they needed to automate several
manual assays used in the evaluation of thrombophilia and
bleeding disorders.
Situation Overview
When Kim Sanders, Special Hemostasis lead technologist, came
to work each morning, she was met with a host of samples. These
samples were from in-house patients as well as samples sent in
from physicians throughout the greater Houston area. As the
number of samples increased and test menus expanded, Kim
realized that the lab’s needs had outgrown the capabilities of
existing instruments.
“We needed to increase efficiency and grow our outreach
work without impacting our operating budget,” says Ziad
Dajani, laboratory director. Better tests that offered improved
clinical utility with less tech involvement were what the lab was
looking for. Constraints with adding manpower led Dajani to
realize the need for a new hemostasis analyzer that could
automate more procedures.
A labor-intensive area of the lab was lupus anticoagulant
testing. The lab used the hexagonal phase phospholipid assay
for the confirmation of a lupus anticoagulant. This test was
cumbersome and required five different vials of reagents.
“When I ran the hexagonal phospholipid assay, it was hard
to even answer the phone,” Sanders says. “I had to run it
separately, and because of all the incubation steps, it completely
occupied my time.”
She added that results could be hard to interpret and she
needed something easier that still conformed to ISTH/SSC
guidelines for the diagnosis of a lupus anticoagulant.
Solution
Laboratory officials had much to consider in selecting a new
hemostasis system that could meet their existing needs with room
to expand for future growth.
The ACL TOP® Hemostasis Analyzer and series of automated
HemosIL® assays offered increased onboard reagent capacity along
with sophisticated reagent management, including barcoded
96 JULY 2010 • advance /Laboratory • www.advanceweb.com
reagents with detailed reagent tracking.
Reducing time-consuming manual entry of lot-specific values,
HemosIL reagents’ lot specific values are encrypted on a
two-dimensional bar code. This allows for the direct importation of
lot-specific calibrator, control and reagent ISI values. The choice
was clear, and the lab went forward with implementation.
Improvements
Technologists used to spend hours running hexagonal
phospholipid and ristocetin cofactor assays, which required
manual manipulations and undivided attention. The ACL TOP
enabled expansion of the test menu to include HemosIL Silica
Clotting Time (SCT), a companion product to HemosIL LAC
Screen/Confirm.
On the ACL TOP, both assays provide a high level of automation, reflexing to confirmatory tests and performing ratio calculations. Furthermore, the HemosIL SCT and LAC assays meet
guidelines for lupus anticoagulant testing.1
Since lupus anticoagulants are heterogeneous, no one test
should be used to make the diagnosis. Because clinical correlation
is vital, all of our lupus anticoagulant patient reports go out
referenced to the International Consensus Statement for the
Antiphospholipid Syndrome.2
Sanders adds that automated ratio calculations allow her to
spend more time reviewing the results instead of just trying to
get all the work done.
With their new ACL TOP and HemosIL reagents, the lab is able to
automate and simplify testing for lupus anticoagulants and vWF
activity, improving its overall efficiency.
Dajani says the lab is the choice for many area physicians.
Sanders says, “It’s important that we operate as productively and
efficiently as possible, and that’s exactly what the ACL TOP and
HemosIL reagents allow us to do.” n
Dr. Luper is medical director of the Hemostasis and Thrombosis
Laboratory at Spring Branch Medical Center in Houston. (Note:
The laboratory moved in July to sister HCA hospital, West
Houston Medical Center, also in Houston.)
References
1. Pengo V, Tripodi A, Reber G, Rand JH, Ortel TL, et al: Update
of the guidelines for lupus anticoagulant detection. Subcommittee
on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific
and Standardisation Committee of the International Society on
Thrombosis and Haemostasis. J Thromb Haemost 2009;7:1737-40.
2. Miyakis S, Lockshin MD, Atsumi T, et al. International
consensus statement on an update of the classification criteria for
definite antiphospholipid syndrome (APS). J Thromb Haemost
2006;4:295-306.
*ACL TOP and HemosIL are registered trademarks of Instrumentation
Laboratory in the United States and in several international jurisdictions.
Advancing
hemostasis is
in our blood.
ACL TOP Family of Analyzers.
Our commitment to achieving hemostasis excellence.
®
If your goals are to increase efficiency and improve patient care, the ACL TOP
Family puts powerful capabilities at your fingertips. With unprecedented ease
of use, these state-of-the-art instruments offer clotting as well as chromogenic
and immunoturbidimetric testing capabilities, plus a broad menu of routine
and specialty assays.
The ACL TOP Family offers complete disease-state management
through a comprehensive panel of HemosIL® assays. A broad test
menu gives you a complete solution for both routine and speciality
testing. And ACL TOP instruments offer true standardization
throughout the lab.
User-friendly and intuitive, the fully automated ACL TOP Family delivers
24/7 walkaway operation, supported by continuous loading and unloading
of samples, reagents and cuvettes. Even closed-tube sampling and total
automation options are available. With literally no interruptions in workflow,
your lab will maximize throughput and minimize turnaround time.
So ask your Beckman Coulter representative about the ACL TOP Family
today, and get in touch with our industry-leading hemostasis solutions.
Blood Banking
Centrifugation
Immunoassay
Information Systems
www.beckmancoulter.com/hemostasis
Chemistry
Flow Cytometry
Hematology
Hemostasis
Lab Automation
Molecular Diagnostics
Rapid Diagnostics
NEW!
ACL TOP 500 CTS
ACL TOP
ACL TOP CTS
© Copyright 2010 Beckman Coulter, Inc. Beckman Coulter, the stylized logo and Coulter are registered trademarks of Beckman Coulter, Inc.
ACL TOP and HemosIL are registered trademarks of Instrumentation Laboratory in the United States and in several international jurisdictions.
ACL TOP 700 LAS
NEW technology
For additional product information, go to
www.advanceweb.com/labmanager
BioCytex
PTH Control
cellSens™
www.stago-us.com
www.thermofisher.com
www.olympusamerica.com/microscopes
Diagnostica Stago Inc.’s (DSI) BioCytex
products for research-use only cellular
hemostasis applications are now available
directly from DSI. This includes no wash
whole blood quantitative flow cytometry
(QFCM) kits, which monitor antiplatelet
drugs (PLATELET VASP/P2Y12) and
enable study of platelet disorders
(PLATELET Gp/Receptors). The technology is available for kits enabling analysis
of granulocyte and red blood cell receptor
levels (CELLQUANT/REDQUANT kits) and
cells from patients suspected of Paroxysmal Nocturnal Hemoglobinuria (PNH).
Clinical applications include measuring
efficacy of antiplatelet drugs.
PTH Control is a human serum-based
liquid immunoassay quality control
product from Thermo Fisher Scientific
Inc. to monitor parathyroid hormone
tests (PTH) on many automated
platforms (e.g., Abbott Diagnostics,
Beckman Coulter, Roche Diagnostics,
Siemens Healthcare and Tosoh Bioscience). PTH impacts calcium absorption/
release within the human body and has
been linked to osteoporosis. The control
is offered as a tri-level multipack for
coverage of the PTH assay range on
automated methods. Assigned values
expedite setup. Access to the LabLink xL
peer comparison program is available.
Olympus America Inc. cellSens™
microscope imaging software is a fully customizable solution enabling researchers to
move smoothly/quickly from image
capture through processing, analysis and
reporting in a few steps. Advanced
functions (e.g., deconvolution, cell
counting, large area stitching, fluorescence
unmixing and data sharing) are fast and
intuitive. Developed specifically for
Olympus microscope users, cellSens
integrates advanced capabilities with
intuitive operation. The software’s intuitive
interface avoids clutter and adds convenience by displaying only the windows and
tools the user needs at any given time.
(800) 222-2624
(800) 766-7000
(800) 446-5967
Flu Diagnostic Test
Lumigen HyPerBlu
POC PT/INR Testing
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www.beckmancoulter.com
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Arbor Vita Corp. (AVC) offers the AV
Avantage™ A/H5N1 Flu Test, a noninvasive rapid diagnostic device specifically
for detection of the avian influenza A/
H5N1 virus in humans. The test detects
the influenza virus nonstructural protein
1 (NS1) in specimens from throat swabs
or nose swabs in less than 40 minutes,
without complicated sample preparation. In studies conducted in collaboration with NHRC and NAMRU-3, the AVC
flu test demonstrated exceptional
sensitivity and specificity; it utilizes
proprietary PDZ protein technology to
detect the virulence factor NS1 protein
from A/H5N1 viruses.
Lumigen HyPerBlu, a novel chemiluminescent substrate from Beckman Coulter
Inc., enables direct detection of hydrogen
peroxide. With a dynamic range and
bright, sustained chemiluminescence, the
reagent offers convenience for highthroughput screening labs. Substrate
reaction with hydrogen peroxide rapidly
generates sustained high-intensity
luminescence for maximum assay
sensitivity. Direct detection increases
accuracy and simplifies data analysis.
When coupled with oxidases, the reagent
allows indirect oxidase/substrate
detection. A single solution not requiring
mixing, HyPerBlu is stable for one year
when stored in an amber bottle at 2-8°C.
With FDA CLIA-waived status, the Roche
Diagnostics CoaguChek® XS Plus
point-of-care (POC) anticoagulation
monitor for PT/INR blood-clotting time
testing may be used in a broader range of
clinical settings (e.g., labs not meeting
moderate-/high-complexity testing
requirements under CLIA ’88). The system
works with the RALS-Plus information
management system to streamline
regulatory compliance and operations. It
holds up to 1,000 patient results and
reduces sample size requirements to 8 ml.
With two-level, built-in quality controls
(QC), the product offers optional liquid QC
for facilities requiring external measures.
(408) 585-3900
(800) 526-3821
(317) 521-2000
98 JULY 2010 • advance /Laboratory • www.advanceweb.com
Who can really help me grow?
Visit us at
AACC/ASCLS
booth #4820
Only Siemens has the innovative solutions your lab needs
to reach the top and the vision to keep you there.
Planning for your future starts with choosing the right diagnostics partner today. Siemens provides comprehensive
and customizable solutions so laboratorians and clinicians can improve productivity every day. And, with a 130-year
tradition of innovation, you can trust Siemens to stay on the leading edge of emerging trends and technologies,
so together we can set a new standard in patient care for years to come. www.siemens.com/diagnostics
Answers for life.
A91DX-9105-A1-4A00
© 2010 Siemens Healthcare Diagnostics. All rights reserved.
Bio-Rad Laboratories
Reaching Quality. Together.
QUALITY CONTROL
I’m a Quality System
When doctors and patients depend so much on accurate test results,
it’s reassuring to know your quality system is backed by the leader in quality control.
At Bio-Rad, Quality Systems Division, we understand
what you go through to maintain your lab quality
system — since our experts are experienced lab
professionals too. In addition to using the highest
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system. It's also valuable to have programs to
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education efforts. Bio-Rad offers more QC
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Get the assurance you need with Bio-Rad.
For more information, contact your local Bio-Rad office
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US: 1-800-2-BIORAD
Europe: +44-(0)20-8328-2000
Visit us at our AACC Booth #7200
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