LabMedica -Vol. 29 No.2 • 4-2012

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V I S I T
W O R L D ’ S C L I N I C A L L A B O R AT O RY N E W S L E A D E R
ISSN 1068-1760
Vol. 29 No. 2 • 4 / 2012
Molecular Test Accurately
Detects Colon Cancer
A
n innovative multimarker
stool DNA test is highly accurate at detecting precancerous
polyps and early-stage colorectal
cancer (CRC).
The stool DNA test works by
finding signature genetic markers
in stool samples mailed in by
patients and a positive test would
Cord Blood Analysis Provides
Wealth of Biomarkers
B
lood derived from the human
umbilical cord has been analyzed to provide vital health information and identify potential biomarkers. A detailed analysis of
umbilical cord blood (UCB) has
been performed using mass spectroscopy, which gave a broader
spectrum of the proteins present
sensitive diagnostic technique
has been developed that rapidly detects the pathogenic virus
that causes pandemic influenza.
The technique, which is based on
molecular biological methods,
swiftly identifies from patient swab
samples, the Influenza A virus,
designated H1N1 that caused the
Cont’d on page 4
Cont’d on page 6
A
biochemical assay combined
with an algorithm accurately
identified the risk of fetal trisomy
21 and 18 from maternal-blood
cell-free DNA (cfDNS). The noninvasive test enables scientists to
detect the risk that a fetus has the
chromosomal abnormalities that
cause Down syndrome and a
technique has been
developed that could
form the basis of a noninvasive diagnostic method for
the Adenovirus. The biosensor technology developed
can detect the presence of
the virus and it can also
identify the individual strain
as well as the number of
virus particles present.
A
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INSIDE
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A
Two Trisomies Detected
by Assay Plus Algorithm
Viruses Diagnosed
by Electronic Sensor
I
Rapid Test Developed
for Pandemic Influenza
than was previously identified.
Scientists at the Arizona State
University (Tempe, Arizona, USA;
www.asu.edu) in a multiinstitutional effort, pooled UCB samples
from 12 newborns, whose maternal backgrounds varied in terms
of ethnicity, educational background, body weight, exposure to
Cont’d on page 2
V
DAILY CLINICAL LAB NEWS
Image: Molecular model of an Adenovirus
6 New Assays
Added to Specialist
Protein Analyzer
ix fully automated, easy-to-use
assays were added to a specialist
protein analyzer. They provide quantitative results to aid the assessment of a
patient’s immune system. The six
assays include four cerebrospinal fluid
S
Clinical News . . . . . . . 2-40
IFCC Annual Report . . . 19
IFCC News . . . . . . . . . . 33
EFLM Corner . . . . . . . . . 38
Product News . . . . . 16-30
Technical Literature . . . 32
Industry News . . . . . . . . 41
International Calendar . 42
PUBLISHED IN COOPERATION WITH
Cont’d on page 10
Simple Blood Test for
Early Detection of Cancers
A
Rapid Diagnostic Test for
Mixed Malaria Infections
A
simple blood test is being developed that may provide early
detection of many different types of
cancer. The test uses infrared light to
detect infinitesimal changes in the
blood of a person who has a malignant
growth somewhere in the body, even
before the disease has metastasized.
rapid diagnostic test (RDT) has
been developed and evaluated
as a mixed-species infections malaria
antigen (FVM Ag) detection kit. The
kit, which uses monoclonal antibodies, can identify both single-species
Plasmodium falciparum or P. vivax
infections, and mixed infections
Cont’d on page 6
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International Federation
of Clinical Chemistry
and Laboratory Medicine
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Molecular Test Accurately
Detects Colon Cancer
cont’d from cover
be followed by a colonoscopy to
remove the polyps and prevent a subsequent cancer from forming.
The screening test was developed
in a collaboration between Mayo
Clinic (Rochester, MN, USA; www.
mayoclinic.org) and Exact Sciences
Inc (Madison, WI, USA; www.
exactsciences.com). It is highly accurate and significantly more sensitive
than other noninvasive tests at
detecting precancerous tumors such
as adenomas and early-stage cancer.
The scientists performed a blinded,
multicenter, case-control study using
archived stool samples collected in
preservative buffer from 252 patients
with colorectal cancer (CRC), 133
with adenomas equal to or greater
than 1 cm, and 293 individuals with
normal colonoscopy results acting as
controls. The stool DNA (sDNA) test
detects four methylated genes, a
mutant form of the Kirsten rat sarcoma viral oncogene (KRAS), and as a
reference value the α-actin gene,
using quantitative, allele-specific,
real-time target and signal amplification; it also quantifies hemoglobin.
The sDNA test identified 85% of
patients with CRC and 54% of
patients with adenomas equal to or
greater than 1 cm with 90% specificity. The test had a high rate of detection for all nonmetastatic stages of
CRC, with an aggregate 87% detection rate for CRC stages I-III.
Detection rates increased with adenoma size: sensitivity was 64% for
polyps larger than 1 cm, 77% for
those larger than 2 cm, 86% for those
larger than 3 cm, and 92% for those
larger than four cm. The stool DNA
test detected 87% of curable-stage
colorectal cancer in nearly 400 cases.
Importantly, detection sensitivity was
not affected by tumor location or
stage.
The authors concluded that earlystage CRC and large adenomas can
be detected throughout the colorectum and with high levels of accuracy
by the sDNA test. Neoplasm size, but
not anatomical site, affected detection rates. Further studies are needed
to validate the findings in a larger
population and optimize the sDNA
test. Stephen Thibodeau, PhD, a
geneticist at Mayo Clinic, said,
“These data illustrate the strength of
the multimarker stool DNA test to
the critical screening targets - precancers and early-stage cancer, and,
importantly, this test appears to
uniquely represent an accurate noninvasive approach to large polyp
detection, which offers the promise
of actually preventing cancers from
developing.” The study was available online since November 2011 in
the journal Gastroenterology.
Image: Colored scanning electron micrograph (SEM) of colorectal cancer cells
undergoing cell division (Photo courtesy
of Steve Gschmeissner / SPL).
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LabMedica
Cord Blood Analysis Provides Wealth of Biomarkers
EDITORIAL BOARD
cont’d from cover
environmental toxins, and also, to cigarette smoke. With the aid of modern highthroughput mass spectroscopy, UCB can
be rapidly screened to reveal hundreds of
proteins in parallel from a single sample
having a volume of as small as 0.236 cm3.
The samples from the 12 newborns were
combined into a composite. Among the
UCB donors, six were African-American,
five were Caucasian and one was Asian.
The team identified a total of 1,210
proteins using mass spectroscopy. The
findings represent a 6-fold increase in the
number UCB proteins thus far described,
which is a significant advance. The proteins identified are associated with 138
different metabolic and disease pathways
and provide invaluable information for
the identification of biomarkers, which
act as early warning indices of disease,
toxic exposure, or disruptions in cellular
processes. In addition to presenting
intriguing candidates for new biomarkers
in UCB, the study also identified 38 proteins corresponding to existing Food and Drug Administration
(FDA; Silver Spring, MD, USA; www.fda.gov)
approved biomarkers for adult blood.
This type of study improves prospects for early disease diagnosis, by prioritizing biomarkers based on
known proteins linked with disease. The group was
able to obtain the protein data with as little as 240 µL
of blood. This is important, as cord blood is a precious resource, exploited for other medical uses.
Stem cells obtained from UCB for example are used
for bone marrow transplantation and other therapeutic purposes. Of the proteins detected in UCB,
around 25% were previously detected in adults.
Rolf Halden, PhD, the senior author of the study
Rosa I. Sierra-Amor Mexico
Edward J. Bottone United States
Claus Christiansen Denmark
Bernard Gouget France
Jocelyn M. Hicks United States
Anders Kallner Sweden
John A. Koepke United States
Christopher Price United Kingdom
Andreas Rothstein Colombia
Dmitry B. Saprygin Russia
Gérard Siest France
Andrew Wootton United Kingdom
A GLOBETECH PUBLICATION
Published in cooperation with the International Federation
of Clinical Chemistry and Laboratory Medicine (IFCC) and
European Federation of Clinical Chemistry and Laboratory
Medicine (EFLM).
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said, “Mapping of the full spectrum of proteins
detectable in cord blood is the first, critical step in
the discovery of biomarkers to improve human
health.” Mass spectroscopic analysis of UCB offers
the prospect of a global approach to assessing
health risks in newborns, allowing the simultaneous observation of numerous indicators of health
and disease. The technique should be an invaluable
aid to early diagnosis for a range of conditions, with
the potential to dramatically improve health outcomes. The study was published online on January
21, 2012 in the journal Environmental Health
Perspectives
Image: Gloved hand testing white blood cells from umbilical cord blood (Photo courtesy of Colin Cuthbert / SPL).
Two Trisomies Detected by Assay Plus Algorithm
cont’d from cover
genetic disorder known as Edwards’ syndrome. The
new approach is more scalable than other recently
developed genetic screening tests and has the potential
to reduce unnecessary amniocentesis or chorionic villus
sampling (CVS).
The digital analysis of selected regions (DASR) combined with the algorithm, fetal-fraction optimized risk
of trisomy evaluation (FORTE), was studied by Andrew
B. Sparks, PhD, from Aria Diagnostics (San Jose, CA,
USA; www.ariadx.com) and colleagues.
Using cfDNA obtained from maternal blood in a
training set (163 subjects) and a blinded validation set
(167 subjects) Dr. Sparks’ group produced an individualized trisomy risk score for each subject, which correctly discriminated all cases of trisomy 21 and 18 from
disomic cases. All subjects in the validation set passed
quality control, and FORTE performance discriminated
36 of 36 cases of trisomy 21 and 8 of 8 cases of trisomy
18 from 123 of 123 disomic cases.
The DANSR assay and the FORTE algorithm were
also validated for detection of the two trisomies by
Ghalia Ashoor, MD, and colleagues from the University
of London (London, United Kingdom; www.lon.ac.uk).
They assessed the prenatal detection of trisomies 21
labmedica.com
and 18 using maternal-plasma cfDNA obtained at 11 to
13 weeks of gestation. Risk scores for trisomy 21 and
18 were given for 397 samples. The sensitivity for
detecting trisomy 21 and 18 was 100 and 98%, respectively, and the specificity was 100%.
These two studies appeared online January 27,
2012, in the American Journal of Obstetrics &
Gynecology. Dr. Ashoor and her colleagues wrote,
“This nested case-control study has demonstrated that
the DANSR assay with FORTE algorithm represent a
promising method for accurate detection of fetal trisomy 21 and trisomy 18.”
Currently, diagnosis of fetal chromosomal abnormalities, or aneuploidies, relies on invasive testing in
pregnancies identified as high-risk. A technique
known as massively parallel shotgun sequencing
(MPSS) analyzes cell-free DNA (cfDNA) from the
mother’s plasma and has been used to detect trisomy
21 (T21) pregnancies, those with an extra copy of
chromosome 21 that leads to Down syndrome, and
trisomy 18 (T18), the chromosomal defect underlying Edwards’ syndrome. MPSS accurately identifies
the conditions by analyzing the entire genome, but it
requires a large amount of DNA sequencing, limiting
its clinical usefulness
Dan Gueron
Jill Roberge
Jacqueline Miller, PhD
Raymond L Jacobson, PhD
Gerald Slutzky, PhD
Andreas Rothstein
Marcela Jensen
Joseph Ciprut
Brenda Silva
Paul Mills
Doris Mendieta
Renata Castro
Dr. Jutta Ciolek
Christina Chang
Arda Turac
Elif Erkan
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ISSN 1068-1760
Vol.29 No.1. Published, under license, by Globetech Media
LLC; Copyright © 2012. All rights reserved. Reproduction in
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LabMedica International
April/2012
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LabMedica
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Rapid Test Developed for Pandemic Influenza
cont’d from cover
2009 pandemic. Scientists at the RIKEN Omics
Science Center (OSC; Yokohama, Japan;
www.osc.riken.jp) combined both reverse transcriptase (RT) and isothermal DNA amplification
reactions in one step for the assay, which does
away with the need for ribonucleic acid (RNA)
extraction and polymerase chain reaction (PCR).
They adapted the real-time smart-amplification
process (RT-SmartAmp) technique using a fluorescent primer to specifically detect the 2009
influenza A (H1N1) virus within 40 minutes,
without cross reacting with the seasonal A
(H1N1), A (H3N2), or B-type (Victoria) viruses.
The effectiveness of the RT-SmartAmp method
was confirmed in clinical studies carried out at
Japanese hospitals during the period of October
2009 to January 2010, where it outperformed
standard diagnosis tests in both speed and sensitivity. Of a total 255 clinical samples, 140 (54.9%)
were identified as 2009 pandemic A (H1N1)-positive by RT-SmartAmp, compared to only 110
(43.1%) detected by standard diagnostic tests. In
72.8% of all 140 infection-positive cases, the RTSmartAmp assay detected the presence of the pandemic influenza virus within 24 hours of fever
onset.
The human-to-human transmission of new,
highly pathogenic strains of influenza virus poses
today a major threat to human health and to the
security of global society. With its rapid global
spread, the 2009 pandemic influenza virus
reminded the world of this threat, resulting in an
estimated 18,000 deaths worldwide. In Japan,
infected patients over the winter season of 2009
accounted for a staggering 16% of the total population. The scientists concluded that their
results set a new standard for infection diagnosis
speed, providing a highly effective tool for rapidly detecting subtypes of the H5N1 virus and
drug-resistant influenza viruses and promising
support in the battle to prevent global pandemic
infection.
Image: Colored scanning electron micrograph (SEM)
of H1N1 flu virus particles on a cell (Photo courtesy
of the NIBSC).
Simple Blood Test for
Early Detection of Cancers
PRINT MAGAZINE
Image: Colored scanning electron micrograph (SEM) of
lung cancer cells (Photo courtesy of Steve
Gschmeissner / SPL).
INTERACTIVE
DIGITAL EDITION
cont’d from cover
WEB PORTAL
MOBILE VERSION
A team of scientists at Ben-Gurion University of the
Negev (BGU; Be’er Sheva, Israel; www.bgu.ac.il)
developed a device that illuminates cancer cells with
less than 5 mL blood. Various molecules are released
into the bloodstream of patients with cancerous
growths that cause the blood to absorb infrared light
slightly differently compared to that of healthy people.
In the latest clinical trial with 200 patients and a
control group, the test identified specific cancers in
90% of the patients and found other types of cancer, as
well. The researchers are focused on detection of common cancers, such as lung and ovarian cancer. Doctors
believe that it is critical to increase cancer detection in
early stages to prevent the need for long, difficult, and
costly treatments in more advanced stages.
Joseph Kapelushnik, MD, who is head of the
Department of Pediatric Hemato-Oncology at Soroka
hospital (Be’er Sheva, Israel; www.soroka.org) said,
“This investigation is still in the early stages of clinical trials. But the purpose is to develop an efficient,
cheap, and simple method to detect as many types of
cancers as possible. We want to be able to detect cancer while a patient is still feeling good, before it has a
chance to metastasize, meaning fewer treatments,
less suffering and many more lives saved.” More clinical trials will be conducted in the next 18 months.
LabMedica International
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LabMedica
H. Pylori Breath Test
for Children Approved
breath test for children aged 3 to 17 can
detect Helicobacter pylori bacterial infections. The urea breath test (UBT) method is more
convenient compared with invasive H. pylori
tests. It is accurate and noninvasive. No blood,
stool, or biopsy is needed – patients avoid the
potential risks and discomforts associated with
more invasive testing methods.
The test is based on the ability of H. pylori to
break down urea into carbon dioxide, which is
then absorbed from the stomach and eliminated
in the breath. For the test, patients swallow a capsule containing urea made from an isotope of carbon. If H. pylori are present in the stomach, the
urea is broken up and turned into carbon dioxide.
The carbon dioxide is absorbed across the lining
of the stomach and into the blood. It then travels
in the blood to the lungs where it is excreted in
the breath. Samples of exhaled breath are collected, and the isotopic carbon in the exhaled carbon
dioxide is measured.
The BreathTek UBT test for H.pylori is manufactured by Otsuka America Pharmaceutical
(Rockville, MD, USA; www.otsuka-us.com). It
was approved by the US Food and Drug
Administration (FDA; Silver Spring, MD, USA;
www.fda.gov) for adults in 1996. The first breath
test for use in children was approved by the FDA
on February 22, 2012.
The FDA based its approval of the BreathTek
UBT test for children on a multicenter study of
176 patients, comparing its performance to a
composite reference method and demonstrating
95.8 % sensitivity and 99.2 % specificity. An
additional study was done at 1 to 6 months after
therapy to support use for post-treatment monitoring of patients. The sensitivity was 83.3 % and
the specificity was 100 %.
The American College of Gastroenterology
A
(http://gi.org) considers the urea breath test
(UBT) to be the most reliable nonendoscopic
method for discovering H.pylori infections. By
assessing the entire gastric mucosa, BreathTek
UBT avoids the sampling errors seen in biopsy
methods.
H. pylori infections cause chronic stomach
inflammation (gastritis) and ulcers. Most people
with this infection do not have any symptoms
but have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected
people.
“Results from this test, when considered with
a physician’s assessment of the patient’s history,
other risk factors, and professional guidelines,
can quickly indicate infection, which allows a
physician to initiate appropriate health measures
in a timely manner,” said Alberto Gutierrez,
PhD, director of the Office of In Vitro Diagnostic
device evaluation and safety in FDA’s Center for
Devices and Radiological Health.
Image: The BreathTek UBT test is designed to
detect H. pylori bacterial infections (Photo courtesy
of Levent Konuk / Shutterstock).
Viruses Diagnosed by Electronic Sensor
cont’d from cover
Scientists at the University of Leeds (West
Yorkshire, UK; www.leeds.ac.uk) fabricated novel
immunosensors using polyclonal antibodies raised
against a human Adenovirus (Ad5) capsid protein,
which were selectively cleaved into antibody fragments by 2-mercaptoethylamine. The fragments
were immobilized onto a functionalized conducting copolymer matrix comprising polyaniline and 2aminobenzylamine.
The new technique therefore uses antibodies
attached to an electrical sensor. By measuring the
sensor’s electrical changes, the investigators were
able to identify how many virus particles were present, and determine the type of virus dependent on
its response. They demonstrated that the immunosensor constructed shows high affinity to its Ad5
virus ligand, detectable by electrochemical impedance spectroscopy over a broad range of concentrations from 10 to 1012 virus particles/mL, with a
limit of detection (LOD) of 103-virus particles/mL.
Currently, testing for viruses is complicated,
time consuming and requires specialist prepara-
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tion of samples to identify virus DNA. Testing for
viruses could be much quicker, simpler, and ultimately less costly using this new technique. For
patients, this sort of diagnostic would mean faster
treatment. Adenovirus is a common virus found
in vertebrates and causes many illnesses, from the
common cold through to gastroenteritis. People
with strong immune systems are not badly affected by the virus, but for those with a compromised
or immature immune system, it can have fatal
consequences.
Paul A. Milner, PhD, who supervised the study,
said, “For the first time we’ve been able to test for
the presence of a whole virus, rather than having to
seek out its genetic material, and the first time the
number of virus particles has been counted using a
lab-on-a-chip device. These are both exciting developments.” ELISHA Systems Ltd. (Buxton, UK;
www.immunosensors.com) will be the company
commercializing this adenovirus biosensor and
other biosensors for healthcare applications. The
study was published on February 15, 2012, in the
journal Biosensors and Bioelectronics.
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LabMedica
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Collection Device for
Sputum Introduced
new tool has been introduced that makes
collecting oral fluids more accurate and
much easier. The collection tube apparatus will
enable saliva analytes to be integrated effectively
into the clinical laboratory testing process, precisely and hygienically.
The tool, which was developed by the Johns
Hopkins University School of Nursing Center for
Interdisciplinary Salivary Bioscience Research
(CISBR; Baltimore MD, USA; www.nursing.jhu.
edu), will improve the ease of oral fluid collection,
while maintaining the integrity of the biospecimen.
The new Whole Saliva Collection Device is a
small, polypropylene collection tube with an
integral adapter that comes individually
wrapped in a clean, foil pouch with ready-to-go
instructions, and is a universal fit with common
cryogenic vials. The planned availability for the
device was February 2012. Saliva is full of analytes and biomarkers that create a biological
journal of exposure to chemicals and disease,
and genetic variability. However, the collection
of oral fluid has always proved cumbersome,
with scientists depending on swabs or collection
A
cups.
Whole saliva is the gold standard when collecting oral fluid
for biological testing. Its collection avoids the localized secretions of specific salivary glands
making it a more consistent specimen. Whole Saliva can be easily
evaluated for volume collected
and for salivary flow rate. Free
from being compromised by
absorbing materials used with
other collection methods, Whole
Saliva can be assayed for any salivary analyte of interest.
Douglas A. Granger, PhD,
director of CISBR and professor
of Medicine, Nursing, and Public Health at Johns
Hopkins is cofounder of the newly formed commercial company SalivaBio, LLC (Baltimore, MD,
USA; www.salivabio.com). Professor Granger
said, “Our studies show that swabs used to collect
saliva can retain analytes, cause interference with
assays, result in inaccurate estimates of saliva flow
rates, and may even produce inaccurate assay
results. It’s not rocket science; it’s a practical solution that will enable saliva analytes to be integrated effectively into basic and clinical studies and
consumer applications.”
Image: The Whole Saliva collection device (Photo
courtesy of Johns Hopkins University School of
Nursing Center for Interdisciplinary Salivary
Bioscience Research).
Six New Assays Added to Specialist Protein Analyzer
cont’d from cover
(CSF) assays: immunoglobulin G (IgG), IgA, IgM,
and albumin. Complement 1(C1) inactivator in
plasma and serum, for the investigation of hereditary angioedema, and transferrin in serum, for estimation of iron deficiency anaemia, were also added
to the analyzer menu. These additions complement
the panel of assays currently available on SPAplus
including Hevylite immunoglobulin heavy
chain/light chain assays, Freelite serum free light
chain assays, and various complement assays.
Binding Site’s (Birmingham, United Kingdom;
www.bindingsite.co.uk) SPAplus specialist protein
analyzer was designed to bring together instrument, reagents, and support as a package. A compact, turbidimetric platform, the fully automated
SPAPLUS system enables laboratories to maintain
the quality of results and high throughput required
for specialized protein assays. It can be placed
alongside the laboratory’s main-line analyzers or in
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other areas of the laboratory.
Preprogrammed protocols, developed and manufactured by Binding Site, provide sensitive and
reproducible results that match or have greater sensitivity than nephelometry. The modular design
with intuitive Windows based software makes the
SPAplus very easy to use. SPAplus has an expanding
menu of diagnostic tests related to disease state
management and clinical practice guidelines. More
assays will be added during 2012.
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LabMedica
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Rapid Diagnostic Test for Mixed Malaria Infections
cont’d from cover
with these two species. Scientists at the
Chungbuk National University (Republic of
Korea; www.cnu.ac.kr) prepared colloidal
gold–conjugated monoclonal antibodies applied
to cellulose paper strips. They produced three
monoclonal antibodies that recognize the lactate
dehydrogenase of P. falciparum, P. vivax, or both
to develop the first mixed-species infections
malaria antigen-detection kit. They evaluated
the sensitivity of the test and compared it with
comparable commercial RDTs.
The sensitivity and specificity of the kit was
assessed with 722 clinical specimens. The detection limit of 150 parasites/µL for the FVM Ag
RDT for P. falciparum-positive blood samples
was higher than that of the two commercial
RDTs, which was less than 60 parasites/µL. The
detection limit of the RDT for P. vivax-positive
specimens was 250 parasites/µL, which was the
same as that of the NanoSign Malaria Pf/Pan
Ag kit (Bioland Ltd; Ochang, Korea; www.
biolandkorea.com) and lower than that of the
500 parasites/µL for the BioLine Malaria Pf/Pan
Ag kit (Standard Diagnostics Inc.; Suwon, Korea;
www.standardia.com). The results of the study
SIGN U
FOR F P
REE!
showed that the FVM Ag RDT has sensitivities
for P. falciparum, P. vivax, and mixed-species
infection were 96.5%, 95.3%, and 85.7%,
respectively. In addition, its specificity was as
high as 99.4%.
P. falciparum and P. vivax malaria are endemic to many parts of the world and humans can be
coinfected with both species. Because each
Plasmodium species has different biological and
clinical characteristics, accurate differentiation of
the infecting species is essential for effective
treatment. Although microscopy is still the gold
standard for malaria diagnosis, it requires experienced technicians and a microscope,
which are not always available in
remote areas. The authors of the study
concluded that the FVM Ag kit is the
first RDT with the capability to differentiate malaria species. They anticipate that their RDT will be a useful
diagnostic tool that will help improve
the diagnosis and treatment of malaria, particularly in remote areas of the
world. The study was published the
December 2011 issue the American
Journal of Tropical Medicine and
Hygiene.
Identifying Patients
Treated with Tysabri
at Risk for PML
he risk for a rare brain infection called
progressive multifocal leukoencephalopathy (PML) occurs in people using the
drug Tysabri (natalizumab) to treat multiple
sclerosis (MS) or Crohn’s disease (CD).
The Stratify JCV antibody enzymelinked immunosorbent assay (ELISA),
when used with other clinical data from the
patient, can help health care providers
determine the risk of developing PML in
MS and CD patients.
Currently, there is no treatment, prevention, or cure for PML, and no certain way
to predict who will develop it. This test, in
conjunction with other factors, will enable
physicians and patients to assess carefully
the risks and benefits of continuing Tysabri
treatment.
Risk factors have been identified that
increase the chance of Tysabri-treated
patients developing PML. These include
the presence of anti-JCV antibodies, which
reflects prior exposure to JCV, treatment
with Tysabri for more than 2 years, and
treatments with immunosuppressants
before receiving Tysabri.
The US Food and Drug Administration
(FDA; Silver Spring, MD, USA; www.fda.
gov) permitted marketing of the first test,
the Stratify JCV antibody ELISA to help
determine risk of patients developing PML.
The Stratify JCV antibody ELISA test is
manufactured by Focus Diagnostics
(Cypress, CA, USA; www.focusdx.com).
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LabMedica International
April/2012
12
LabMedica
for daily laboratory medicine news click to www.labmedica.com
Noninvasive Probe Characterizes
Skin Cancers Morphologically
and Biochemically
joint US-Dutch team has developed a noninvasive probe capable of
both morphological and biochemical characterization of skin cancers.
The portable instrument combines a Raman spectroscopy (RS) system with
an optical coherence tomography (OCT) device and enables the sequential
acquisition of coregistered OCT and RS data sets. An Andor (Belfast,
Northern Ireland; www.andor.com) high-resolution, near-infraredenhanced Newton camera was chosen as the core element of the Raman
diagnosis module.
The probe was developed under the direction of Anita Mahadevan-Jansen
from Vanderbilt University (Nashville, TN, USA; www.vanderbilt.edu). It
screens large areas of skin up to 15 mm wide to a depth of 2.4 mm with
OCT to visualize microstructural irregularities and perform an initial morphological analysis of lesions. The OCT
images are then used to identify locations to acquire biochemically specific
Raman spectra.
“Having demonstrated the clinical
potential of the RS-OCT instrument to
rapidly screen at risk patients, we are
continuing to develop the dual-modal
technique for other applications where
noninvasive assessment of both
microstructure and biochemical composition are critical to accurate assessment of pathology,” said Chetan Patil
from Vanderbilt University.
Skin cancer is the most common
form of human cancer with annual
rates continuing to climb from their
current estimate of just over three million new cases each year. Although all
skin cancers share the likelihood of a
favorable outcome if early diagnosis
and complete resection are achieved,
diagnosis is invasive, subjective,
lengthy, and expensive, involving
expert visual inspection, biopsy, and
histopathology.
A
Image: An OCT image (upper) shows a
set of hyporeflective regions in the dermis beneath the red arrow that probably
correspond to cancerous tumor cell nests
based on the pathology. The tumor cells
are also shown in a representative histology (middle; 10x magnification, scale bar
= 150 µm). The mean Raman spectra
exhibit distinct differences between the
cancerous and normal cells in the
regions centered at 1090, 1300, and
1440 cm-1 (Photo courtesy of Andor
Technology).
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LabMedica
Gastroenterologists View Tissue In Situ
Using Confocal Laser Endomicroscope
he confocal laser endomicroscope allows
physicians to examine a patient’s GI tissue at
the cellular level in its natural environment. This
results in fewer biopsies being sent to pathology
labs. The tiny microscope is called Cell viZio and
is manufactured by Mauna Kea Technologies
(MKEA; Newtown, PA, USA; www.maunakea
tech.com), a French company with offices in the
United States. Cell viZio is a miniature microscope
that, once inserted into the GI tract, enables the
physician to select cells for microscopic examination in order to make a more immediate decision
regarding a diagnosis, as well as treatment.
The Cell viZio system was cleared by the Food
and Drug Administration (FDA) and has received
CE mark in Europe. The company’s second-generation system, the Cell viZio 100 series was cleared
in Europe and the United States in 2011.
Although this micro-miniature microscope allows
gastroenterologists to evaluate individual cells and
identify abnormal or malignant tissue, there will
still be a need to collect a tissue biopsy for analysis
of its DNA, RNA, and/or proteins. The complexity of those genetic tests and molecular diagnostics
assays means that most of these tissue referrals
T
will continue to be sent to pathologists.
One contributing technology that went into
this micro-miniature microscope is a high-density
chip capable of performing several functions
within a tiny module. Essentially, the Cell viZio
system is a focal probe threaded through a traditional endoscope. Dangerous tissue can be identified during the initial diagnostic exam. This
allows gastroenterologists to remove this tissue
the same day, and then go back to ensure that all
of the diseased tissue was removed. This new
approach will be applied to gastrointestinal cancers and other GI diseases, including those of the
colon, bile duct, pancreas, and esophagus.
The Cell viZio system has the potential to pull
more testing away from the traditional anatomic
pathology laboratory. Michael J. Cima, PhD, at the
Massachusetts Institute of Technology (MIT;
Cambridge, MA, USA; http://mit.edu), recognized that possibility when he stated that, by using
these types of systems to look at tissue in situ, “we
are going to bring the laboratory into the patient.”
Image: Surgeon using the Cell viZio imaging system with an endoscope to examine a patient (Photo
courtesy of Mauna Kea Technologies).
Recombinant Human Serum Albumin Is Animal-Free
company that develops, manufactures, and
markets a portfolio of products used in cell culture, diagnostics, and bioproduction has developed
recombinant human serum albumin that is completely animal-free.
Animal-derived media components carry safety
concerns involving the risk of viral and prion contamination. As a result, regulatory bodies in the
United States, Europe, and Japan have discouraged
the use of these components in biomanufacturing.
In addition to safety concerns, animal components
frequently have high batch-to-batch variation,
which leads to unpredictable manufacturing
results.
InVitria (Fort Collins, CO, USA; www.invitria.
com) was awarded a USD 725,000 Phase II, Small
Business Innovation Research (SBIR) Grant to
broaden the applications for InVitria’s recombinant
human serum albumin product Cellastim.
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The Phase II grant was awarded in 2009 by the
National Institutes of Health (NIH; Bethesda, MD,
USA; www.nih.gov) as a two-year project, which
was successfully completed on time in 2011. “We
are delighted that the objectives of the grant were
achieved. The team exceeded those objectives and
also implemented current Good Manufacturing
Process (cGMP) quality standards for manufacturing recombinant human serum albumin,” said
Scott Deeter, president of InVitria.
InVitria is a Division of Ventria Bioscience, the
developer of the ExpressTec biomanufacturing system. ExpressTec is the first biomanufacturing system to commercialize recombinant protein manufacturing utilizing plants as the host. InVitria’s product line consists of completely animal-free cell culture media supplements and reagents that are distributed globally by leading distributors in life sciences and cell culture media.
LabMedica International
April/2012
14
LabMedica
for daily laboratory medicine news click to www.labmedica.com
Air Ambulance Upgrades Blood
Glucose Monitoring System
n Air Ambulance company has upgraded its
blood glucose monitoring system used across
a wide range of glucose levels prior to, during,
and after emergency flight transfers. CEGA Air
Ambulance (www.cega-air-ambulance.com) is
now using using Roche (Basel, Switzerland;
www.roche.com) Accu-Chek Inform II blood glucose monitoring strips.
The Accu-Chek Inform II test strips have
undergone extensive evaluation, including studies
at over 30 external sites as well as thorough internal testing. These evaluations demonstrated that
the strips provide accurate and reliable blood glucose measurements under a variety conditions,
including wide haematocrit and environmental
ranges, and in presence of maltose.
The strips require a minimal sample volume of
A
Methylation-Based
Biomarker Indicates
Chemo Resistance of
Colorectal Cancer
just 0.6 µL and deliver accurate results from alternative sampling sites, such as the palm and forearm.
The air company’s senior flight nurse, Stuart
Cox commented, “After reviewing all the kits that
are available on the market, we felt that the Roche
Accu-Chek Inform II test strips best met our
requirements for high quality patient care in the air
ambulance. The user interface is very simple and
straightforward to use anywhere and by any of our
trained staff. In addition, the strips have a very
good range compared to other systems, giving
accurate results at both high and low glucose levels, which is essential for patient safety.”
Stress-induced insulin resistance and hyperglycaemia is common in critically ill patients and close
monitoring of blood glucose levels is an important
part of their care. Studies have shown that mainte-
Click on the
nance of appropriate glycaemic control in such
patients improves morbidity and mortality.
CEGA was established in 1973 as an air taxi
service. Operations soon changed to meet a growing demand for worldwide repatriation of sick and
injured holidaymakers and domestic National
Health Service (NHS; www.nhs.uk) transfers by
Ambulance Aircraft.
Image: CEGA Air Ambulance uses Accu-Chek
Inform II blood glucose testing strips for patient safety during emergency flight transfers (Photo courtesy
of CEGA Air Ambulance / Roche).
below to watch the video
ypermethylation of the TFAP2E gene was correlated with nonresponsiveness of colorectal cancer to a commonly used chemotherapeutic agent.
In a study involving more than 200 patients in
four independent cohorts, Prof. Ebert at the
University of Heidelberg (Germany; www.
uni-heidelberg.de) and his team demonstrated that
hypermethylation of the TFAP2E gene was correlated with nonresponsiveness of colorectal cancer to
the commonly used chemotherapeutic agent 5-fluorouracil (5-FU). The study was reported in the
January 2012 edition of the New England Journal of
Medicine (www.nejm.org).
Using a combination of data from cancer cell lines
and patient samples, the authors demonstrated that
this effect was potentially mediated through up-regulation of the DKK4 gene, previously implicated in 5FU resistance. Resistance to treatment was observed
with 5-FU based chemotherapy or 5-FU chemotherapy combined with radiation, indicating that
TFAP2E methylation may be a valuable biomarker
for response prediction in either setting.
The study demonstrates the growing role that biomarkers can play in the management of cancer and
other diseases. Prof. Ebert commented: “In practical
terms, we believe this study demonstrates the potential that novel DNA methylation biomarkers may
have in improving the selection of therapies for this
deadly disease. A prospective validation of the marker is, however, still required.”
Epigenomics AG (Berlin, Germany, and Seattle,
WA, USA; www.epigenomics.com) scientists believe
that the study demonstrates the potential of TFAP2E
and other biomarkers identified in Epigenomics’
DNA methylation discovery pipeline in supporting
clinical decision making.
Epigenomics’ lead product, Epi proColon, is a
blood-based test for the early detection of colorectal
cancer, which is currently marketed in Europe and is
in development for the United States.
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PRODUCT NEWS
REAL-TIME QPCR KIT
Daan Diagnostics
The RT qPCR product range
includes hepatitis, STD, respiratory
pathogen, digestive pathogen, avian
influenza virus, tumor markers,
torch, and public health. Key benefits include enhanced sensitivity,
accuracy, flexibility, and cost-effectiveness.
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RANDOM
ACCESS ANALYZER
FACE SHIELD
Karl Hecht
AdvanDx
Erba Mannheim
The Assistent face shield covers the
entire face, can be used with goggles, and is designed to decrease
contamination risk. It can be autoclaved at 121°C for up to 20 minutes, and is disposed of after use.
The QuickFISH tests features only a
five-minute hands-on time, and a 20minute turnaround time for fast identification of bacteria. The tests have
built-in universal controls, and limited required instrumentation allows
for easy and inexpensive implementation and testing.
The XL-1000 automated analyzer
features sample clot detection,
three-reagent capacity, and diffraction grating with 15 wavelengths
from 340-800 nm. The system also
offers a nine-cuvette wash station,
and throughput up to 1120 tests/hr.
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Extraction Methods Compared for Molecular Detection of Pathogens
hree mechanistically different sample extraction methodologies were evaluated for their
abilities to purify nucleic acids from blood culture
fluids.
The three methods were silica spin columns,
phenol-chloroform, and an automated magnetic
capture of polymer-complexed DNA via an
Automate Express instrument, and were followed
by polymerase chain reaction (PCR) assays for the
detection of Staphylococcus aureus.
Scientists at Applied Molecular Testing,
(Life Technologies, Carlsbad, CA, USA; www.
lifetechnologies.com) analyzed 60 blood cultures
spiked with bacterial pathogens. On separate
days, three replicates from each of the sample
aliquots were thawed and processed using the
DNeasy blood and tissue kit (Qiagen, Hilden,
Germany; www.qiagen.com), phenol-chloroform,
or an ABI Automate Express forensic DNA extraction system.
The extracts from silica columns required 100-
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to 1,000-fold dilutions to reduce sufficiently the
powerful PCR inhibitory effects of the anticoagulant sodium polyanetholsulfonate, a common
additive in blood culture media. In contrast, samples extracted by either phenol-chloroform or the
Automate Express instrument required little or no
dilution, respectively, allowing for an approximate 100-fold improvement in assay sensitivity.
Analysis of 60 blood culture bottles indicated
that the phenol-chloroform (Invitrogen, Carlsbad,
CA; www.invitrogen.com)and the ABI extraction
(Foster City, CA, USA; www.appliedbiosystems.
com) methodologies could be used to detect lower
numbers of pathogens and that a growing S. aureus
culture could be detected two hours earlier than
when using silica columns. Of the three tested
methodologies, the Automate Express instrument
had the shortest time to result, requiring only
approximately 80 minutes to process 12 samples.
The authors concluded that their findings
highlight the importance of considering the
LMI-04-12 116
mechanism when selecting a DNA extraction
methodology, given that certain PCR inhibitors
act in a similar fashion to DNA in certain chemical environments, resulting in copurification,
whereas other methodologies use different
chemistries that have advantages during the DNA
purification of certain types of samples. The study
was published in March 2012, in the Journal of
Molecular Diagnostics
Assay Detects Antibodies
Associated with HeparinInduced Thrombocytopenia
fully automated panel for the detection of
heparin-induced thrombocytopenia (HIT) has
been released. The assays provide enhanced detection of HIT antibodies in specialty and hospital
hemostasis laboratories.
The panel includes HemosIL AcuStar HIT-IgG
(PF4-H) and HemosIL AcuStar HIT-Ab (PF4-H)
assays. These are on-demand, fully automated,
chemiluminescent reagents on a hemostasis testing
system for the detection of antibodies associated
with HIT.
The ready-to-use, cartridge-based assays offer
results in approximately 30 minutes, on-demand,
24/7. The precalibrated reagent cartridges offer significant time- and cost-efficiencies.
HIT is a severe immunologic adverse reaction to
heparin, paradoxically resulting in venous and/or
arterial thrombosis. It is one of the most common of
all adverse drug effects, due to the large number of
patients receiving heparin therapy.
If HIT is untreated, the risk of dangerous conditions developing such as stroke, pulmonary
embolism, and even death increases significantly.
The assays are products of Instrumentation
Laboratory (Bedford, MA, USA; www.ilus.com).
The new HemosIL AcuStar HIT Assay Panel assay
has been released as a European CE in vitro diagnostic (IVD) Mark product. The assays are not currently 510(k) cleared.
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CHEMISTRY ANALYZER
HEMOSTATIS ANALYZER
ELECTRONIC PIPETTES
POCT TEST
Spinreact
Tcoag
Socorex
Wondfo Biotech
The Spin640 features 90 positions
for primary or secondary tubes and
sample cups. Added benefits include
interior and exterior automatic probe
washing, STAT sample priority, 80
positions for reagent handling, and a
throughput of 400 tests per hour / up
to 640 tests per hour with ISE.
The Destiny Max offers optical or
micromechanical clot detection with
reliable cap piercing and standardization of results. Operational software features a user-friendly graphic
interface that enables flexible and
convenient operation with continuous sample processing.
The Acura electro pipette line consists of three models designed for an
extended range of sample handling
performance. Key features of the
user-friendly and energy-efficient
line include intuitive interface, easy
tip ejection, enhanced hand comfort
and control.
The HIV 1/2 one-step test is
designed for use with whole blood,
serum or plasma. The test offers
high sensitivity and specificity, can
be stored in room temperature, and
allows for a shelf life of 24 months.
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One in Six Pregnant Women
Tested Positive for Hypothyroidism
he study of half a million pregnant women in the United States
found 15.5% of those tested were
positive for gestational hypothyroidism, much higher than previously
estimated.
Scientists at Quest Diagnostics
(Madison, NJ, USA; www.questdiagnostics.com) performed the first largescale study to analyze the prevalence
of hypothyroidism during pregnancy.
The study was based on clinical guidelines issued by the American Thyroid
Association (ATA; Falls Church, VI,
USA; www.thyroid.org) in 2011, and
strongly suggests far more women are
at risk for the disorder than suggested
by prior studies.
Gestational hypothyroidism is
increasingly being associated with a
range of medical complications for
women and their babies, including
miscarriage, pregnancy-induced hypertension, gestational diabetes, lowbirth weight, and abnormal fetal
brain development, which may lead
to a lower IQ.
The ATA’s guidelines are the first
from a medical association to recommend specific reference ranges for
TSH blood levels based on recent data
showing an association between low
TSH levels, once believed to be harmless, and adverse health outcomes.
The condition can be treated with
FDA-approved oral therapies.
Pediatric endocrinologist Jon M.
Nakamoto, MD, PhD, medical director for Quest Diagnostics and associate
clinical professor at Rady Children’s
Hospital (San Diego, CA, USA;
www.rchsd.org) and the University of
California, San Diego (CA, USA;
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http://ucsd.edu) said, “With the
growing awareness of risks that even
subclinical hypothyroidism can pose
for the mother and fetus, it’s important
that practitioners recognize the true
prevalence of this condition.”
The study assessed results of
502,036 pregnant women who
received lab testing through Quest
Diagnostics between 2005 and 2008.
Of these women, only about one in
four, or 23% (117,892), was tested
for TSH level. Among the pregnant
women who were tested for TSH
level, 18,291, or 15.5%, had heightened levels of TSH consistent with
hypothyroidism as defined by the
ATA guidelines.
The study also found that women
aged 35 through 40 years were 1.8
times more likely to develop gestational hypothyroidism as those ages 18
through 24 years. Nearly one in five
Asian women (19.3%) tested had TSH
results consistent with hypothyroidism, the highest of any other ethnic group. Women weighing over 124
kg were 2.5 times as likely to develop
gestational hypothyroidism as those
weighing between 45 kg and 56 kg.
Only one in five women, or
20.7%, with gestational hypothyroidism were tested within six
months after giving birth. Of these
women, 11.5% tested positive for
hypothyroidism. Symptoms of postpartum hypothyroidism can range
from fatigue and depression, to irritability and weight gain.
The present study was published
online in the December 2011 in the
Journal of Clinical Endocrinology &
Metabolism (JCEM).
LabMedica International
April/2012
18
International Federation of Clinical Chemistry and Laboratory Medicine
2011 ANNUAL REPORT
HIGHLIGHTS OF THE YEAR
WorldLab Berlin, May 15-19, 2011
IFCC Council in Berlin on May 15, 2011
IFCC-Beckman Coulter Distinguished Clinical Chemist Award: Prof.
Emeritus Ulf-Hakan Stenman, Finland
IFCC-Siemens Henry Wishinsky Award for Distinguished International
Services: Dr. Carl A Burtis, USA
IFCC-Abbott Award for Distinguished Contributions in Education: Prof.
Mary F Burritt, USA
IFCC-Abbott Award for Significant Contributions in Molecular Diagnostics: Prof. Michael Neumaier, Germany
IFCC Distinguished Award for Laboratory Medicine and Patient Care:
Prof. Ronald J A Wanders, The Netherlands
IFCC-Robert Schaffer Award for Outstanding Achievements in the
Development of Standards for Use in Laboratory Medicine Co-sponsored
by NIST and CLSI: Prof. Linda Thienpont, Belgium
IFCC-Roche Young Investigator Award (from 2011): Prof. Rossa W K
Chiu, Hong Kong
IUPAC International Year of Chemistry 2011
Congress of the Latin-American Confederation of Clinical Biochemistry
(COLABIOCLI) in Punta Cana, Dominican Republic
Congress of the African Federation of Clinical Chemistry in Nairobi,
Kenya
The second Ortho Clinical Diagnostics Conference held in Paris
Molecular Biology Course in Guatemala, December 2011
Abbott Laboratories' annual sponsorship of the IFCC-VLP program
IFCC Speakers Bureau
Joint IFCC-“Labs are Vital” campaign, sponsored by Abbott Diagnostics
Laboratories
IFCC Siemens Healthcare Diagnostics Distance Learning Project
Roche / IFCC Travel Scholarship
New IFCC Website launched
PRESIDENT’S MESSAGE
2011: The Year When the World of Clinical Chemistry Came to Berlin
by Graham Beastall, IFCC President
t is a pleasure to write this summary of the year 2011 on behalf
Ienjoyable,
of IFCC. My third year as president has been just as busy and
as the first two years, but with the added bonus of the
three yearly Council meeting and the IFCC WorldLab congress in
Berlin. As this Annual Report will demonstrate, IFCC remains strong and in good heart; 2011 was
a year of progress on many fronts.
Membership. IFCC once again increased its membership during 2011. We now have 85 Full
Members with the Nepal Association for Medical Laboratory Science joining during the year. We
increased our Affiliate Membership by two in 2011 with the welcome addition of the “Association of
Medical Biochemists of India” and the “Association of Clinical Chemistry and Laboratory Medicine
of Ukraine” Corporate Membership of IFCC is also growing despite the continued consolidation in
the industry and during 2011 we added Labquality Unilabs Ltd, Shenzhen Mindray Bio-Medical
Electronics Co. Ltd., Nova Biomedical Corporation, Immunodiagnostic Systems (IDS), Response
Biomedical Corporation. I am delighted to report that all the new IFCC members are actively
engaged with the work of the Federation.
Implementation of the Strategic Plan. The Executive Board achieved further success with the
implementation of its Strategic Plan. Amongst the 2011 achievements were:
• The launch of the new IFCC Website, which is less fussy, more responsive, and easy for the
IFCC Office team to update (www.ifcc.org)
• A decision by Council to change the composition of the Executive Board and to adopt electronic
voting for the election of future executive Boards
• A decision by Council to introduce a differential membership fee
• Acceptance for publication of a document entitled "Proposals for the mitigation of the environmental impact of clinical laboratories.” This project was led by Joseph Lopez and Tony Badrick
and represents the first significant review of this important topic
• Release of a distance learning program on laboratory accreditation and the creation of a support structure to enhance distance learning within IFCC
• Launch of the “Appliance of Science” as a simple way to understand and promote the added
value of clinical chemistry and laboratory medicine to healthcare.
Overall, IFCC completed 23 of the 26 Strategic Actions that it set itself for the period 2009 to
2011.
Congresses and Conferences. Congresses and conferences are an essential part of the work of
IFCC. Not only do they provide an opportunity to update our scientific and clinical knowledge, skills
and experience but they also provide a great forum to meet and make friends and to build long lasting professional networks.
The highlight of 2011 was the IFCC WorldLab congress, which was held in conjunction with the
EuroMedLab European congress in Berlin. This was a hugely successful international occasion
with participation from delegates and exhibitors from almost one hundred countries. The excellent
International Conference of Pediatric Laboratory Medicine was held as a satellite conference to the
WorldLab event.
Two other IFCC Regional Organizations also held successful congresses:
• Latin-American Confederation of Clinical Biochemistry (COLABIOCLI) in Punta Cana in the
Dominican Republic
• African Federation of Clinical Chemistry in Nairobi, Kenya
The second Ortho Clinical Diagnostics Conference was held in Paris. This focused event
demonstrated a very high standard of presentation and discussion on the topic of “Pregnancy
Related Disorders: Present Perspectives and Emerging Challenges”
The Team Approach. Much of the most significant work of IFCC takes place in its Divisions,
Committees, and Working Groups. This annual report contains many excellent examples and I
encourage you to read these. In addition, the IFCC Task Forces and Integrated Projects address
significant issues, often in partnership with international clinical organizations, as part of the work
to position clinical chemistry and laboratory medicine at the center of the multidisciplinary healthcare team. During 2011, we agreed to commence a new Committee on Distance Learning and new
Task Forces on Point of Care Testing and The Impact of Laboratory Medicine on Clinical
Management and Outcomes. These new initiatives will start in 2012.
Finances. The annual accounts for 2011 were audited in February 2012 and copies are available
upon request from the IFCC Office. The success of the IFCC WorldLab congress in Berlin helped
to produce a good year for IFCC finances. However, we must not be complacent because the global financial situation remains fragile and investment income is unpredictable. Further details can be
seen in the Treasurer's report.
People. During 2011, several key individuals completed their terms of office within IFCC and I thank
them and pay tribute to their skill and commitment. These include:
• Päivi Laitinen, Honorary Secretary (2006-2011)
• Ghassan Shannan, Treasurer (2006-2011)
• Joseph Lopez, Member of Executive (2006-2011)
• Janet Smith, Chair of Education and Management Division (2006-2011)
• Chris Lam, Vice President (2009-2011)
A new Executive Board will commence its work in January 2012 and it is a pleasure to welcome
Howard Morris, Sergio Bernardini, Vanessa Steenkamp, and Larry Kricka to the team. Maurizio
Ferrari will succeed Janet Smith.
The three-yearly IFCC Awards were presented during the IFCC WorldLab congress in Berlin.
Details will be reported elsewhere in this Report. I wish to express my personal congratulations,
both to the seven winners and also to the many other outstanding scientists who were nominated
by their national societies.
Thanks. I wish to thank the Executive Board and the Chairs of Divisions for their skill, commitment,
and inspiration and especially Päivi Laitinen, in her capacity as Honorary Secretary, who has been
responsible for the production of this Annual Report and so much more. Paola Bramati, Silvia
Cattaneo, and Silvia Colli-Lanzi, appointed during the year, have demonstrated their dedication and
a high level of professionalism in supporting members from our IFCC Office in Milan.
IFCC owes a great debt to the hundreds of scientists and medical doctors who work on a voluntary basis to give freely of their time and expertise in the interests of improving the quality, delivery, and relevance of clinical chemistry and laboratory medicine on a worldwide basis. It is gratifying that we are seeing an increase in the number of experts who want to work for IFCC. These people are the true strength of IFCC and I thank them all.
Personal Note. I had expected that this would be my final Annual Report, written at the end of my
three-year term of Office as President. It was a surprise to me when I was asked by several colleagues to offer myself for reelection and I regard it as a great honor that Council elected me for a
second term. I will work hard to repay the faith that you have shown in me and I look forward to
connecting with more Members and to helping work with other agencies to promote the essential
contribution of clinical chemistry and laboratory medicine to healthcare and to the safety and wellbeing of patients and the public.
Special Supplement to Lab Medica International
2
2011 Annual Report
EXECUTIVE BOARD (EB)
The Executive Board held three meetings during 2011. The first meeting was held in connection with the
IFCC OCD Conference in Paris on February 27-28, 2011. The second EB meeting was held prior the
WorldLab Berlin 2011 on May 13-14, 2011. The new Executive Board was elected at a Council meeting held
in Berlin on May 15, 2011. The third EB meeting was held in Milan on November 19-21, 2011. This was a
joint meeting of the newly elected EB members and retiring member. This was also a budget meeting in
which all the Division Chairs also attended and presented the work of their respective Division and its budget proposal for the next year.
IFCC family gained a new member during the year. The Nepal Association for Medical Laboratory Science
(NAMLS) was approved unanimously as a new Full Member by the IFCC membership via a mail ballot. The
application of the Association of Clinical Biochemists in Zimbabwe - ACBZ, was sent out for voting with a
deadline of January 31, 2012. At the end of 2011, the IFCC had thus 85 Full Members. IFCC also gained
new Corporate Members (Immunodiagnostic Systems, Merck Millipore, Mindray, Nova Biomedical,
Labquality, Response Biomedical Corporation). They all are warmly welcomed into the Federation
A letter was sent to National Societies of the Full and Affiliate Members requesting for their annual reports.
Forty-five reports were received to be included in the IFCC Annual Report 2011, which is available on the
IFCC Website (www.ifcc.org). The full detailed annual reports of the Divisions as well as Task Forces' activ-
A QUICK VIEW OF IFCC FINANCES
IFCC ASSET PERFORMANCE 2011 (%)
%
IFCC Office 9%
MAJOR EXPENSES
Finance &
Domicile 2%
Regional
Organizations 8%
Special
Projects
4%
CPD 5%
International
Organizations
3%
GC 1%
Awards 3%
SD 7%
C-CC 50%
MAJOR INCOME
Full & Affiliate
Members 6%
Corporate Members 9%
EuroMedLab 3%
Royalties 2%
Bank
Profit 1%
EMD 2%
SD 2%
ities are included in the IFCC Annual Report. Regional Federations are an essential part of the IFCC and they
also give their annual reports to be part of the IFCC Annual Report. Please, visit the Website to know more
of IFCC.
This IFCC Annual Report 2011 closes my two terms as IFCC Secretary. These have been remarkable six
years during which I have learned a great deal of laboratory medicine as well as people, different cultures
and countries. I wish to express my sincere thanks and great gratitude to Executive Board members in 20062011 as well as all IFCC officials and the staff of Emmezeta-MZ Congressi. It has been a privilege to work
with you. I also want to express my special thanks to the staff of the IFCC office in Milan; you have helped
me greatly in my work as IFCC Secretary.
Päivi Laitinen, Secretary IFCC
Treasurer
2011 was one of the best years financially for a long time; income from WorldLab was the largest since this
series started. In addition, IFCC had received several late payments, namely income from EuroMedLab in
Glasgow 2005 and travel sponsorship from Roche. However, the bad news is that the performance of IFCC
assets was still poor due to the continuous recession in the global market. The issue of the IFCC assets was
discussed extensively at the Executive Board who recommended a visit to LGT Bank in Geneva by the
President and the new Treasurer of the IFCC to explore the best possible ways to improve the profitability of
the IFCC assets.
The understanding of the Executive Board, Division and Committee Chairs and IFCC officers had contributed to the saving made in 2011 as they tried to minimize their expenses to the minimum.
The reimbursement process went smoothly in 2011, thanks to the online banking and the efficiency and
hard work of the IFCC office staff.
With the valuable help and assistance of IFCC office, we were able to secure the payment of the annual
dues of Full, Affiliate and Corporate Members for 2011.
Below is a diagram showing the percentage of the major income of IFCC during 2011. There was a significant increase from Corporate Members contribution due to the joining of several new members during
2011. The income from Full & Affiliate Members had also increased due to the expansion of membership by
adding new countries to IFCC club. Sponsorship from IVD still plays a major role in assisting IFCC to implement the scientific activities.
As one can gather from the diagram, most expenses went to C-CC, as IFCC had to pay the costs associated with WorldLab Berlin 2011, the linked International Conference of Pediatric Laboratory Medicine and
other partners. The operating cost of IFCC declined; but still made about 9% of total expenses. The contribution to Regional Organizations made about 8% of the total expenses. IFCC Divisions & Committees continued to support the scientific activities of various regions through sponsoring Workshops & Symposia; in
addition, IFCC continued to sponsor various programs like VLP, PSEP, and Analytical Quality.
The IFCC Financial Advisory Committee is pleased with the present Auditors, Humphreys & Gates, who
perform professional auditing of IFCC accounting, whose contract was extended until the end of 2014.
IFCC continues to maintain investment account at LGT and three accounts in EUR, USD, and CHF at
Credit Suisse. Both banks have shown a great deal of cooperation and understanding with the treasurer and
the office staff.
The graph below shows the performance of IFCC assets in 2011. It was another disappointment as the
total loss was about 6.5% at the end of the year. Such performance raises again the question; is there a better way to invest the IFCC assets?
Finally, I wish to extend my sincere thanks and gratitude to the Executive Boards, Division Chairs, IFCC
officers, National Societies, Corporate Members, MZ and above all IFCC office staff for the unlimited support
I received during my two terms as a Treasurer of the IFCC. I hope I was up to your expectations and looking forward to meeting you all in the future.
Ghassan Shannan, Treasurer
Awards Committee
The Federation confers several distinguished awards to scientists and clinicians who work in clinical chemistry and laboratory medicine or related disciplines. These triennial or annual awards are the highest honors
that our Federation can bestow to colleagues worldwide in recognition of their outstanding achievements, to
publicize their exceptional research and other contributions that have improved medical and healthcare, and
to stimulate and encourage other scientists to accelerate their efforts in advancing clinical chemistry and laboratory medicine.
EB 3%
EMD 5%
Pediatric Conf. 2%
IFCC
Awards Committee. Members of the present 2009 to 2011 IFCC Awards Committee conducting the nominations and selection of honorees comprise: Chair C W K Lam (Hong Kong), Members: Jean-Claude Forest
(Canada), Vladimir Palicka (Czeck Republic), Mohamed Shaarawy (Egypt), Rosa Sierra-Amor (Mexico),
Consultant: Y M Dennis Lo (Hong Kong).
Presentation of 2011 Award. Currently there are seven IFCC distinguished awards: The awards were
announced at the Opening Ceremony of WorldLab Berlin 2011 and they were presented to the Awardees at
a Awards Gala Dinner during the congress.
IFCC-Beckman Coulter Distinguished Clinical Chemist Award. Outstanding contributions to the science
of Clinical Chemistry and Laboratory Medicine, or the application of Clinical Chemistry to the understanding
or solution of medical problems. Professor Emeritus Ulf-Håkan Stenman, Finland
IFCC-Siemens Henry Wishinsky Award for Distinguished International Services. Unique contributions
to the promotion and understanding of Clinical Chemistry and Laboratory Medicine throughout the world. Dr.
Carl A Burtis, USA
Sponsorship
5%
IFCC-Abbott Award for Distinguished Contributions in Education. Extraordinary contributions in establishing and developing educational materials for our discipline to improve training and educational programs
worldwide or in a region. Prof. Mary F Burritt, USA
Awards 2%
IFCC-Abbott Award for Significant Contributions in Molecular Diagnostics. Unique contributions to the
promotion and understanding of molecular biology and its application In Clinical Chemistry and Laboratory
Medicine worldwide. Prof. Michael Neumaier, Germany
IFCC Distinguished Award for Laboratory Medicine and Patient Care. Unique contributions in Laboratory
Medicine, its application in improving patient care and having a worldwide impact in clinical medicine. Prof.
Ronald J A Wanders, The Netherlands
WorldLab 66%
IFCC-Robert Schaffer Award for Outstanding Achievements in the Development of Standards for Use
in Laboratory Medicine Cosponsored by NIST and CLSI. Outstanding and unique contributions to the
advancement of reference methods and/or reference materials for Laboratory Medicine to facilitate improved
quality of clinical diagnostics and therapies, which would in turn lead to reduced costs and improved patient
care . Prof. Linda Thienpont, Belgium
Special Supplement to Lab Medica International • 20
IFCC
2011 Annual Report
IFCC-ROCHE Young Investigator Award . Recognizes and encourages the academic and professional
development of a young investigator who has demonstrated exceptional scientific achievements in Clinical
Chemistry and Laboratory Medicine early in his/ her career. Prof. Rossa W K Chiu, Hong Kong
C W K Lam, Awards Committee, Chair
CORPORATE MEMBERS
3
were 6 Platinum Sponsors, 2 Gold Sponsors, 11 Bronze Sponsors (17 of them are IFCC Corporate
Members), and 74 exhibitors. According to a request by IFCC Corporate Members, the opening hours of the
exhibition were reduced to only three days, from Monday to Wednesday, instead of the whole congress, from
10:00 to 17:00.
EuroMedLab 2013, Milan, Italy. Francesco Caggiano, Menarini, has been appointed as consultant at the
Congress Organizing Committee (COC) representing IFCC Corporate Members.
2011 was another year with extremely challenging global economical conditions and budget constraints for
the majority of IVD companies. Nevertheless, Corporate Members contributed significantly to the overall
IFCC budget, sponsored IFCC Scientific Awards, and continued supporting IFCC activities e.g. working in all
three IFCC Divisions in their Executive Committees. In addition, numerous delegates from Corporate
Members actively collaborated in most of the scientific workgroups.
WorldLab 2014, Istanbul, Turkey. Thomas Brinkmann, Unilabs, has been appointed as member of the
Congress Organizing Committee (COC) representing IFCC Corporate Members.
Number of Corporate Members. In 2011, six IVD companies joined IFCC as Corporate Members:
Immunodiagnostics Systems (UK), Labquality (Finland), Nova Biomedical Corporation (France), Response
Biomedical Corporation (Canada), Shenzhen Mindray Bio-Medical Electronics (China), Unilabs
(Switzerland). Due to the acquisition of Phadia by ThermoFisher one member was lost. By the end of 2011,
the total number of Corporate Members increased to 46 with a total annual dues of CHF 327,500 representing 20% of the IFCC annual budget.
There are five main Regional Professional Laboratory Medicine Organizations which can be considered
IFCC regional partners
• European Federation of Clinical Chemistry and Laboratory Medicine (EFCC)
• Asian-Pacific Federation of Clinical Biochemistry (APFCB)
• Arab Federation of Clinical Biochemistry (AFCB)
• Latin-American Confederation of Clinical Biochemistry / Confederación Latinoamericana de Bioquímica
Clínica (COLABIOCLI)
• African Federation of Clinical Chemistry (AFCC)
More information about these affiliated organizations and their activities can be found on our website
www.ifcc.org
Corporate Members' Meeting. In 2011, two Corporate Members' meetings were organized in conjunction
with international conferences: EuroMedLab in Berlin (May 2011) and AACC in Atlanta, USA (July 2011).
IFCC officers of the Executive Board participated in the first third of these meetings to welcome new members and to discuss with Corporate Members. The direct contact with IFCC officers strengthens communication and equal partnership collaboration between IVD industry and IFCC.
IFCC Committees. Corporate Members contributed in the following three IFCC Divisions: Scientific Division,
Joseph Passarelli (Roche); Education & Management Division, Rolf Hinzmann (Roche); Communications &
Publications Division, Bruce Jordan (Roche). In addition, Corporate Members worked in many IFCC committees.
EMD Executive Committee (EC). The EMD Executive Committee (EC) met twice: in January in Varese,
ltaly, and in May in Berlin during IFCC EuroMedLab / WorldLab. Educational activities, mainly lectures, have
been very successful.
A very important task of EMD is the Visiting Lecture program, sponsored by Abbott with EUR 40,000 per
annum. Another teaching activity was a beginners' lab course on molecular diagnostics held in Guatemala in
December, which was organized by Prof. Michael Neumaier, Mannheim, Germany.
The Committee on Analytical Quality (chaired by Janice Gill, Australia, and Egon Amann, Siemens,
Germany) is quite successfully pursuing the establishment of a quality assurance program in Vietnam by lectures, on-site training and invitation of a Vietnamese physician to an Australian lab.
A monograph on laboratory management is currently being written and now in the process of finalization.
A distance learning material from Siemens (on natriuretic peptides) can be reached on the Siemens Website
(via an IFCC link). Other distance learning materials are in process. The Working Group on New Bone Marker
Standards in Osteoporosis has completed a publication, and will move to the Scientific Division. The Working
Group on Flow Cytometry is now chaired by Prof. Ulrich Sack. Beckman Coulter will continue sponsorship
for flow cytometry courses.
SD Executive Committee (EC). Two face-to-face meetings were held within the Scientific Division in 2011.
Both were two days in duration. The first was held on May 14-15 in conjunction with the IFCC EuroMedLab
/ WorldLab in Berlin, Germany. The second occurred in Milan, Italy, at the IFCC offices on October 7-8.
The publication by Nader Rifai that appeared in Clinical Chemistry and the subsequent rebuttal that was
sent in by EDMA and AdvaMed to explain Corporate Members alternative position. By-and-large CM supports disclosure of manufacturer's names in most cases but manufacturers believe there should be flexibility in certain circumstances to allow exceptions to this. The SD understood CM's position, especially with the
concern that this could limit funding from industry for important studies that they want to initiate or continue.
The SD also discussed the “Global Reference Interval Study” from Prof. Ichihara and the C-RIDL.
Several meetings took place together with CM in Munich (December 2010), Berlin (May 2011), and Atlanta
(July 2011). Corporate Members still had several significant questions and concerns with the proposed studies. In the end, the SD agreed only to the common collection protocol so that sample collection could proceed. SD decided in favor of regional reference intervals following a common protocol.
Request by Corporate Members to have at least 9 months and preferably, 12 months prior notice of any
requests for funding new studies given CM's internal budgeting processes. The SD fully understood this position. Further discussions are ongoing.
As previously mentioned in open meetings with Corporate Members, it was discussed that the SD
requires new Committees and Working Groups to demonstrate the clinical and economic value whenever
requesting funding. Given the significant reductions in R&D spending and the more stringent guidelines being
placed on external funding, it is no longer enough to provide just an explanation of the scientific interest. Also
the medical value (both to patients and payers) has to be defined and demonstrated.
Many Corporate Members expressed their scientific interest in POCT. They will support the new Task
Force being formed.
EuroMedLab / WorldLab 2011 Berlin, Germany. The EuroMedLab / WorldLab conference in Berlin was a
great success with 4,685 participants from 98 countries and 93 industry exhibitors. IFCC Corporate Members
were represented by the Corporate Representative at the Congress Organizing Committee (COC).
The Industry Sponsored Workshops (ISW) were again a excellent way for in vitro diagnostic companies
to contact and improve their relations with participants. It turned out that sometimes ISW were better attended than the main sessions, especially when the latter dealt with more abstract scientific topics. The ISW were
of possible immediate practical use. Number of ISW and corresponding number of attendants: day 1, 16 ISW
with 2,248 attendants; day 2, 16 ISW with 2,324 attendants; day 3, 10 ISW with 908 attendants; day 4, 2 ISW
with 269 attendants.
The IFCC EuroMedLab / WorldLab Berlin 2011 COC decided to modify the usual categories of promotional involvement employed for the last IFCC/EFCC events into Platinum, Gold, Silver, and Bronze Sponsors
in order to implement the possibilities offered to Corporate Members in addition to standard exhibitors and
sponsors. One significant advantage granted to Platinum, Gold, Silver, and Bronze Sponsors was the priority in the selection of exhibition space and sponsorship, according to a chronological order of reservation.
IFCC corporate member were given the advantage of a discount of 20% on the official price. Finally there
Thomas Brinkmann, Corporate Representative
REGIONAL ORGANIZATIONS AFFILIATED WITH IFCC
COMMITTEE ON CONGRESSES AND CONFERENCES (C-CC)
C-CC Meetings. The C-CC held one committee meeting (28th Meeting) on Sunday, May 15, 2011, at ICC
Berlin-International Congress Center, Berlin Germany.
C-CC Membership. The C-CC received 11 applications from Full Member Societies for the vacant Full
Member position commencing January 2012 for a three-year period. IFCC EB accepted Dr. Joseph LOPEZ
nominated by Malaysia and APFCB for the vacant Full Member position in C-CC. The IFCC EB also accepted the recommendations of Orla Maguire from Ireland; Montserrat Blanes Gonzalez from Paraguay; Pierre
Carayon from France; and Tomas Zima from Czech Republic as Corresponding Members for a three-year
period commencing January 1, 2012.
Upon recommendation of C-CC, IFCC EB accepted Dr. Peng Yin from Abbott as the Corporate Member
of C-CC, and Dr. Mauri Keinanen from Labquality as the Corresponding Corporate Member effective January
1, 2012.
International Congresses of
Clinical Chemistry and Laboratory Medicine
Berlin WorldLab 2011 (XXI International Congress of Clinical Chemistry and Laboratory Medicine,
ICCCLM), Berlin Germany, May 15-19, 2011
The IFCC WorldLab Berlin 2011 (XXI ICCCLM) was held concurrently with the IFCC-EFCC EuroMedLab
from May 15-19, 2011, in Berlin, Germany. The congress was hosted by the German Society of Clinical
Chemistry and Laboratory Medicine (DKGL). The congress was an outstanding success. Some statistics are
given in the Corporate Members report above.
ICCCLM ISTANBUL WorldLab 2014
The first Congress Organizing Committee (COC) meeting was held on February 9, 2012, in Istanbul, Turkey.
ICCCLM WorldLab 2017, Durban, South Africa
IFCC received a record number of eight bids from four continents to host this congress (Argentina, Austria,
India, Ireland, South Africa, Spain, Sweden, and Tunisia). Each of the bids, together with letters of support,
was evaluated by the C-CC. The evaluation was performed and scored in line with the published “Guidelines
and Rules for Organizing the IFCC International Congresses of Clinical Chemistry and Laboratory Medicine.”
Working independently each of the five C-CC assessors scored Durban in the first place. Accordingly, the CCC made a recommendation that “IFCC WorldLab 2017” should be awarded to Durban and the Executive
Board has endorsed this recommendation. IFCC WorldLab 2017 will be held in Durban in the Republic of
South Africa during the last week of October 2017. The official announcement of the venue for “IFCC
WorldLab 2017” was made during the IFCC Council meeting in Berlin in May 2011.
Regional Congresses
XIX COLABIOCLI Congress, Punta Cana, Dominican Republic 2011
The COLABIOCLI meeting was held in Punta Cana in the Dominican Republic in November 2011.
EuroMedLab Milan 2013
The congress, will take place from May 19-23, 2013, (Sunday-Thursday). Preparations for the congress are
progressing smoothly as planned.
EuroMedLab 2015
Six National Societies submitted their applications to host the EuroMedLab 2015. The IFCC Congresses and
Conferences Committee (C-CC) and the EFCC Education and Training Committee (C-ET) evaluated the submitted applications and issued advice to national societies. The venue for the IFCC-EFCC EuroMedLab
Congress in 2015 was selected by ballot at the EFCC General Assembly in Berlin on Sunday, May 15.
According to the results of the ballot, EuroMedLab 2015 will be organized by the French Society of Clinical
Biology (SFBC) at “Palais des Congrés de Paris.”
IFCC Specialized Conferences
IFCC Ortho Clinical Diagnostics (OCD) Conference, Paris February 25-26, 2011
The Second Ortho Clinical Diagnostics (OCD) Conference entitled "Disease and the Clinical Laboratory
Pregnancy Related Disorders: Present Perspectives and Emerging Challenges" was held in Paris, February
25-26, 2011. This conference had 4 sessions with topics - prenatal screening, preeclampsia, prediction of
Special Supplement to Lab Medica International • 21
4
2011 Annual Report
preterm birth and novel biomarkers and 13 lectures were presented. The participants (approx. 90) came to
Paris from 28 countries around the word. The presentations will be inserted into the IFCC Website and will
be published also in CCLM.
CONGRESSES WITH IFCC AUSPICES
A total of 32 meetings in 2011 and 26 meetings in 2012 have applied for IFCC auspices for their meetings,
and since the meeting topics are directly related to the goals of the IFCC, all of them were granted IFCC auspices.
Revision of the Documents and Guidelines
The reviewed and revised documents and guidelines are available on the IFCC Website.
Tomris Ozben, C-CC Chair
SCIENTIFIC DIVISION (SD)
During 2011, the following members served on the SD Executive Committee: Ian Young (UK) Chair), Philippe
Gillery (France) (Vice-Chair), Gary Myers (United States) (Secretary), Giampaolo Merlini (Italy), Lothar
Siekmann (Germany), Naotaka Hamasaki (Japan), and Joseph Passarelli (Germany) (corporate representative). Three representatives of International Organizations are invited to attend the SD meetings as consultants: Mathias M_ller (JCTLM), Heinz Schimmel (IRMM), and David Bunk (NIST). Two meetings were held
during the year 2011: May 14-15 (Berlin, Germany) and October 7-8 (Milan, Italy).
IFCC
Committees
• C-Nomenclature, Properties and Units (C-NPU)
During 2011 ongoing progress towards C-NPU terms of reference included:
Term of Reference 1. Provide advice for the management, updating and publishing of the NPU terminology. Accomplishments include: The revision of the "Silver Book": Compendium of Terminology and
Nomenclature of Properties in Clinical Laboratory Sciences (IUPAC and IFCC Recommendations 1995) has
been extended. The objective is to finalize the updating of the first edition of the Silver Book (project #2007033-1) by inserting a new chapter on nominal properties and adding a concise summary of the content as a
double sheet leaflet. This extension is supported by SD and CPD.
Term of Reference 2. Make recommendations on NPU for reporting clinical laboratory data that conform to
or adopt current standards of authoritative organizations and that will improve their utilization for health care.
Accomplishments include: A manuscript entitled “Vocabulary for nominal properties and nominal examinations-Basic and general concepts and associated terms” was adopted by IUPAC and distributed for review.
The document was submitted to Pure and Applied Chemistry for publication. SD was under the impression
that the document would be published in CCLM as a discussion document only. The editor of Pure and
Applied Chemistry was contacted to request a hold be placed on publication to allow IFCC to follow its publication guidelines and send the manuscript out for comment and vote.
Term of Reference 3. To provide a connection with other organizations concerned with NPU, such as the
Bureau International des Poids et Mesures (BIPM), the European Committee for Standardization (CEN) and
the International Organization for Standardization (ISO), and, by extension, clinical laboratory sciences societies, such as the International Union of Pure and Applied Chemistry (IUPAC). Accomplishments include:
All of the above activities were jointly performed with IUPAC.
• C-Molecular Diagnostics (C-MD)
Relationship with International Organizations
The SD continues to pursue its activities to partner with international organizations to promote the implementation of the concept of traceability in laboratory medicine and the implementation of reference measurement systems.
• Joint Committee on Traceability in Laboratory Medicine (JCTLM)
The work of JCTLM is available for review on its database at www.bipm.org/jctlm. The Working Group 1 on
Reference Measurement Procedures and Reference Materials continues its program of identifying and
reviewing new proposals against agreed criteria (ISO standards 15193 and 15194). More than 200 certified
reference materials for about 130 measurands together with more than 125 reference measurement methods/procedures for 76 different health markers are presently listed in the JCTLM database. These have been
reviewed and internationally agreed to be consistent with the criteria described in the standard ISO 15194
and 15193, respectively. The Working Group 2 on Reference Measurement Services has reviewed new nominations from candidate laboratories. Laboratories will now need to participate in RELA EQAS once in 3 years
for each measurand for which the laboratory is listed on the JCTLM database. To be listed as a laboratory
providing reference services, a laboratory will need to be accredited by January 2011. A procedure is in place
to periodically review the lists and to remove entries when they no longer meet the established criteria. A new
working group (WG 3) charged with managing, writing, and reviewing material and publications on behalf of
JCTLM is being considered. The database has become a reliable source of information particularly for the In
Vitro Diagnostics (IVD) industry.
• Insitute for Reference Material and Measurement (IRMM)
Close collaboration with IRMM continues through a number of joint ventures involving SD Committees and
Working Groups. A new material for cystatin C has been released. Projects continue for the preparation of
materials for HbA1c (primary and secondary materials), HbA2, and myoglobin.
• Clinical and Laboratory Standards Institute (CLSI) (Formerly NCCLS)
An updated list of joint CLSI/IFCC documents is available on the IFCC Website at: www.ifcc.org/
ifcc-communications-publications-division-(cpd)/ifcc-publications/clsi-ifcc-joint-projects/.
• National Institute of Standards and Technology (NIST)
NIST continues to undertake a large number of projects, many of which are of considerable interest to IFCC.
Standard Reference Materials (SRM) released or slated for release in 2011 include: SRM 968e (Fat soluble
Vitamins and Carotenoids), SRM 1950 (Metabolites in human plasma) is a one level fresh frozen human
plasma with concentrations established for glucose, creatinine, fatty acids, folate, homocysteine, cholesterol,
cortisol, progesterone, testosterone, retinol, tocopherol, carotenoids, 25-hydroxyvitamin D, uric acid, amino
acids, total protein, and electrolytes, SRM 3951 (Vitamin B12), SRM 900a (Antiepilepsy Drugs), SRM 3667
(creatinine in urine), and SRM 1951c (lipids in frozen human serum). NIST indicated it would like SD assistance with conducting commutability studies of its reference materials including; logistical help to conduct
commutability studies, assistance obtaining patient samples, and assistance in contacting manufactures.
There was discussion that there may be a need for an oversight group within SD for commutability issues
and logistics.
• International Congress of Clinical Chemistry (ICCC)
XXI INTERNATIONAL CONGRESS OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE (WORLDLAB 2011) Berlin, Germany (May 15-20, 2011). Two SD submitted sessions were presented during the IFCC
Congress. Topics were; 1. IFCC Program on Molecular Diagnostics (Ian Young as Chair) and 2. What
IFCC/JCTLM is doing in traceability (Philippe Gillery as Chair).
IFCC Specialized Conferences
IFCC-ORTHO CLINICAL DIAGNOSTICS. The 2011 Conference held in Paris, France (February 25-26,
2011): “Pregnancy-related disorders: present perspectives and emerging challenges” was attended by 100
participants. A special issue of CCLM will contain presentations from the conference.
Congresses with IFCC Auspices
4th CIRME INTERNATIONAL SCIENTIFIC MEETING Milan, Italy (November 30, 2011). onference title:
Standardization of Cardiac Troponin I: The Ongoing International Effort. Under the auspices of the IFCC,
JCTLM, and the EFCC.
Activities of Committees and Working Groups
The Committees (Cs), which are theme-oriented, carry out much of the scientific and professional activities
of the SD. Their work is often in close collaboration with other international organizations. For more specific
tasks, the activities are usually accomplished through Working Groups (WGs).
During 2011 ongoing progress towards C-MD terms of reference included:
Term of Reference 1. To foster dynamic exchanges between IFCC and Mol DX labs and industry.
Accomplishments include: The C-MD Web page contains a link to the CanGeneTest Newsletter. The eNewsletter on genetic laboratory services aims at disseminating timely and relevant information in this area
to all stakeholders.
Term of Reference 2. Guidelines on validation, conduct, and reporting of Mol DX tests. Accomplishments
include: A consensus of available guidelines on molecular DX testing is available on the C-MD Web page.
Term of Reference 3. Provision of well-defined reference materials. Accomplishments include: The C-MD
Website provides a listing of available reference materials and EQA programs for Mol DX. A project (GETTIN) was submitted to the EU Commission in partnership with IRMM for a reference material for molecular
methods possessing suitable characteristics to be used in the clinical environment. Unfortunately, the project did not pass to the second step.
Term of Reference 4. Creation of a network of locus specific IFCC Molecular Diagnostic Centers.
Accomplishments include: C-MD has not clarified the position on roles of MDCs. The goal was to have a
network of MDCs as a resource of expertise within IFCC. However, the visibility of the MDC's is relatively low
and there were concerns that the network was overlapping with the EuroGentest initiative. A letter was sent
in January 2011 to the MD Centers requesting a report on the specific activities performed by each Center.
Term of Reference 5. C-MD Web page within IFCC Website. Accomplishments include: The Website contains links to other Websites relevant to molecular diagnostics including genetic and molecular genetics societies, gene sequence and mutation databases, primer design sites, and a number of other molecular diagnostic utilities.
• C-Plasma Proteins (C-PP)
SD closed C-PP at the end of 2010. Members of C-PP were invited to propose the formation of WGs to take
forward specific tasks arising out of C-PP work. One proposal was to form a WG for the development and
preparation of a new international reference material for cerebrospinal fluid (CSF) proteins. The aim of this
project would be to develop an international reference material for cerebrospinal fluid. The detection and
quantification of proteins is an essential part of the diagnosis and monitoring of a number of neurological diseases. For a correct diagnosis of CSF analytes, it is important that there is an international standardization
of CSF tests traceable to an international reference material. SD supported the proposal and the formation
of a WG has been agreed.
• C-Reference Systems for Enzymes (C-RSE)
During 2011 ongoing progress towards C-RSE terms of reference included:
Term of Reference 1. IFCC Enzyme Reference Measurement Procedures: New 37 °C IFCC enzyme reference procedures are being developed on the basis of the existing 30 °C IFCC. Accomplishments include:
Work on the development of a reference measurement procedure for pancreatic lipase continues. The results
of the experiments planned to compare the performances of two candidate reference methods for pancreatic lipase catalytic activity were completed in spring 2011. The experimental results were contradictory and
not satisfactory for both methods, therefore optimization of both methods is proceeding in parallel.
Term of Reference 2 and 3. Network of Enzyme Reference Laboratories: Coordination of a group of reference laboratories from hospitals, academy and industry, which are able to perform adequate measurements
according to a list of stated requirements. Enzyme Reference Materials: Evaluate reference materials provided by IRMM within the network of reference laboratories prior to certification. Accomplishments include:
No activity on these Terms of Reference occurred.
• C-Traceability in Laboratory Medicine (C-TLM)
During 2011 ongoing progress towards C-TLM terms of reference included:
Term of Reference 1. Support activities of the JCTLM - based on a harmonized opinion among IFCC members - concerning the identification of reference measurement procedures, reference materials, and reference laboratories. Accomplishments include: C-TLM provided input into the activities and operations of
JCTLM Working Groups 1 and 2.
Term of Reference 2. Establish an External Quality Assessment Scheme (EQAS) for reference laboratories
and act as an advisory committee. Accomplishments include: To date, RELA ring trials are provided for 34
measurands. Starting with RELA 2010, Total Thyroxine and Total Triiodthyronine are provided in a separate
group “Thyroid Hormones (THYR).” The number of participants and of published results is increasing. The
results with disclosed identities of the laboratories are published on the RELA Website (www.dgkl-rfb.de:81).
The measurand alkaline phosphatase has been running for the first time and eight laboratories participated.
In September 2011 the next RELA survey (RELA 2011) was started. The results will be available in June
2012.
Term of Reference 3. Promote the establishment and maintenance of IFCC reference laboratory networks
for clinically relevant measurands. Accomplishments include: The annual meeting of the Reference
Laboratories operating the IFCC Reference Measurement Procedure for HbA1c was held during the IFCC
Special Supplement to Lab Medica International • 22
IFCC
2011 Annual Report
WorldLab 2011 in Berlin on May 15, 2011. Candidate reference laboratories in China (Shanghai; Dr. Li Qing)
and India (Calcutta; Dr. Bhattacharya) were introduced. A third Asian candidate reference laboratory (Korea,
Seoul) exists, however it was not introduced to the network. The 2011 intercomparison study of the network
laboratory performance has been started. Results will be available in 2012.
• C-Reference Intervals and Decision Limits (C-RIDL)
During 2011 ongoing progress towards C-RIDL terms of reference included:
Term of Reference 1. Review current concepts of establishing reference intervals and decision limits and to
prepare state-of-the-art position statements regarding new avenues to make available reference intervals
and decision limits that respect the requirements of international directives, such as the European IVD
Directive 98/79, and relevant ISO standards. Accomplishments include: No activity on this Term of
Reference occurred.
Term of Reference 2. To monitor and evaluate currently proposed reference intervals for selected analytes
in the light of the concept of traceability and of the identification of the uncertainty. Accomplishments
include: 53 analytes (26 biochemistry; 27 immunoassays) were selected to be tested as part of phase 1 of
the worldwide study.
Term of Reference 3. To monitor and evaluate currently proposed reference intervals for selected analytes
in the light of the concept of traceability and of the identification of the uncertainty. Accomplishments
include: A common collection protocol was developed and finalized in September 2011 for the worldwide
project on reference values. The study will focus on developing regional reference intervals following the
common protocol in favor of global reference intervals. A pilot study was carried out in April-May of 2011 to
evaluate the validity of the panel-of-sera strategy in streamlining test results with participation of four testing
centers in the US, Turkey, and Japan. The first phase of the worldwide study was launched in November 2011
with participation of 7 major laboratories located in five countries: US, UK, Turkey, China, and Japan.
Term of Reference 4. To establish transferability protocols of reference intervals and decision limits, which
take into consideration inter-routine laboratory method variations and achieve better applicability in clinical
practice. Accomplishments include: There was no activity relevant to this term.
Term of Reference 5. To collaborate with other organizations and/or to undertake establishment of reference
intervals or decision limits for analytes identified as a priority. Accomplishments include: A workshop was
presented during the IFCC WorldLab 2011 in Berlin on May 24 (Tue): Lessons from the Asian - Pacific multicenter reference interval study. A symposium during 2011 AACC annual meeting in Atlanta on July 25 (Mon):
Is that normal? Reference interval studies around the world.
Term of Reference 6. To work in close collaboration with other Cs and WGs of SD for the development and
appropriate clinical utilization of reference intervals and decision limits. Accomplishments include:
Collaborated with C-RSE to collect samples from reference subjects for ALP.
Working Groups
• WG - Standardization of Thyroid Function Tests (WG-STFT)
During 2011 ongoing progress towards WG-STFT terms of reference included:
Term of Reference. Development of reference measurement systems for thyroid hormones (total T4 and T3,
free T4 & T3) and TSH. Accomplishments include: The University of Ghent (UGent) developed and published Equilibrium Dialysis Isotope Dilution-Liquid Chromatography/Tandem Mass Spectrometry (ED IDLC/tandem MS) measurement procedure for serum free T4 was accepted by the IFCC as an international
conventional reference measurement procedure (RMP). The RMP has also been approved by the JCTLM for
listing in the JCTLM database of approved RMPs. The same is expected for the reference measurement
service provided by the UGent laboratory, after accreditation of the laboratory according to ISO 17025/15195.
The accreditation is anticipated to happen in 2012; SD approved the closure of the WG-STFT at the end of
2011 and the formation of a committee on thyroid function. The aims for the transformation of the WG-STFT
into a committee are to prepare the implementation of standardization, to involve a broader forum of stakeholders and to accomplish the commitment of the stakeholders to standardization. The SD approved the
Terms of Reference for the Committee.
• WG - Standardization of Hemoglobin A2 (WG-HbA2)
During 2011 ongoing progress towards WG-HbA2 terms of reference included:
Term of Reference. To promote the standardization of hemoglobin A2 measurement through the definition
of an international reference system, including a reference measurement procedure and primary and secondary reference materials. Accomplishments include: Development of the reference method: Two labeled
peptides have been defined (i.e. aT11 and dT2 peptides, having one labeled valine with all the C atoms as
13
C), purchased and analyzed by amino acid analysis. The development of an isotopic dilution mass spectrometry method using these peptides is under evaluation. An alternate approach using LC-ESI/MS on intact
globin chains, by adapting the method described by Davison et al (Clin Chem Lab Med 2008;1230-8), is also
being investigated. A third approach, based on the implementation of the proteolytic and isotopically labeled
method by LC-ESI-MS/MS proposed by Dalton et al. (Clin Chem 2007; 53:1448-54) is under discussion for
evaluation.
Secondary reference materials: The stability study at -20 °C on the first pilot batch of candidate reference material (CRM) prepared back in April 2008, has been continued. The stability and homogeneity of a
second batch of materials with other vials, as well as other gas atmospheres (oxygen free) inside the vials,
is planned in the first part of 2012.
• WG - Standardization of Carbohydrate-Deficient Transferrin (WG-CDT)
During 2011 ongoing progress towards WG-CDT terms of reference included:
Term of Reference 1. Establish a network of CDT reference laboratories that perform the HPLC candidate
reference method. Accomplishments include: Six laboratories belonging to WG members are running the
HPLC candidate reference method. A multicenter study (Study 3) in March 2011 confirmed the homogeneity
of the results given by the candidate reference method within the network. Results showed low and very good
CV (a calibrated mean CV of 1.7%) and true linearity (r >0.99) for both native and spiked materials. All CDT
assays involved in Study 3 showed excellent or acceptable linearity. However, the inter-method CV was relatively high (13-16%) and the calibration curves were not parallel, indicating that multiple-point calibration will
be needed. Due to slight differences in the response between native and spiked samples, use of native samples was considered necessary. The non-HPLC methods showed variable matrix effects for the spiked samples. These results demonstrated that calibration of the different CDT assays is possible. A draft manuscript
describing the HPLC candidate reference method is in preparation.
Term of Reference 2. Development of a reference material for CDT. Accomplishments include: A confirmatory calibration study (Study 4) based on native samples from 40 different individuals with variable CDT
levels was performed according to CLSI protocols 14a and 53 using the HPLC reference method and available methods on the market. Study 4 is designed to demonstrate that standardization can be achieved using
individual patient samples. .A multilevel secondary calibrator based on native material will be required.
5
• WG - Standardization of Cystatin C Assays (WG-SCC)
2011 was the last official working year for the WG-SCC. During 2011 ongoing progress towards WG-SCC
terms of reference included:
Term of Reference 1. Promote the standardization of cystatin C measurement through the definition of an
international reference system including a reference measurement procedure and primary and secondary
reference materials. Accomplishments include: The WG, in cooperation with major diagnostic companies, worked to establish a method-independent cystatin C-based GFR-prediction equation, using samples
from 4000 patients with known GFR. Results for 2000 samples have been produced and results for the
remaining 2000 samples will be obtained in early 2012. The large number of patients differing in GFR, age,
health status, etc, will allow reliable statistical characterization of the diagnostic performance of the GFRprediction equation in various subgroups of patients/healthy persons and will allow decisions concerning if
different prediction equations will be required for different subgroups of subjects.
• WG - Standardization of Glomerular
Filtration Rate Assessment (WG-GFRA)
During 2011 ongoing progress towards WG-GFRA terms of reference included:
Term of Reference 1. Coordinate, support, and undertake collaborative international studies to evaluate and define performance characteristics of available clinical laboratory measurement procedures
for creatinine, supporting the use of eGFR, and enabling development of best-practices analytical
recommendations for clinical laboratories. Accomplishments include: In cooperation with NKDEP
Lab Working Group (including funding from NIH/NIDDK), completed analysis of data from the collaborative specificity study for 3 Jaffe and 4 enzymatic serum creatinine measurement procedures from
four major global IVD systems manufacturers (Roche, Siemens, Beckman, and Ortho). Manuscript
was submitted (July 2011) to Clinical Chemistry for publication, and was accepted for publication
(October 2011).
Term of Reference 2. Promote the establishment and growth of a reference laboratory network for creatinine measurements in serum and urine. Accomplishments include: Creatinine specificity study report
(online supplement), to be published in Clinical Chemistry, 2012, includes full disclosure/ procedural detail
for the Evelina Children's Hospital, London, UK, creatinine LC tandem mass spectrometry procedure used
as the designated comparison measurement procedure. It is anticipated that reference and calibration laboratories may have significant interest in this measurement procedure, and publication of these details is
expected to facilitate wider availability of higher order creatinine measurements.
• WG - Standardization of Albumin Assay in Urine (WG-SAU)
During 2011 ongoing progress towards WG-SAU terms of reference included:
Term of Reference 1. Establish a reference procedure and reference materials for the measurement of albumin in urine. Accomplishments include: The NIST is developing an LC-MS/MS reference measurement
procedure for urine albumin that measures eight tryptic peptides of human serum albumin with ~1% CV for
replicates. NIST will validate this procedure by comparison with the procedure developed at the Mayo Clinic.
The Mayo Clinic procedure uses five tryptic peptides that are consistently seen by LC IDMS and averages
the results for a final value. Inter- and intra-assay precision is about 1%-2%. The NIST has prepared SRM
3667 (Creatinine in Human Urine), which is a single concentration of pooled urine, collected from healthy
males/females (minimum of 10 donors). LC-IDMS reference measurement procedure-target values have
been assigned. The NIST has prepared SRM 2925 (Human Serum Albumin Solution) from recombinant
human serum albumin and is intended for use as a primary certified reference material for reference measurement procedures for albumin in urine. Quantification by amino acid analysis using isotope dilution LCMS/MS has been completed. A candidate secondary urine albumin reference material has been prepared by
the Japanese Society of Clinical Chemistry. The material is a buffer based purified monomeric human serum
albumin in lyophilized form. The assigned value was by transfer from ERM-DA470 using qualified immunoassay procedures. A commutability study using 129 urine samples was performed with seven different
immunoassay methods. A reduction in between method CV was observed using the new reference material
to calibrate the immunoassays.
Term of Reference 2. Establish recommendations for sample collection and handling to improve uniformity
of results. Accomplishments include: A study to evaluate adsorption of albumin onto containers used for
urine collection and urine albumin measurement has been completed by CDC and a manuscript is being prepared. Planning of a study to evaluate urine albumin physiologic variability was delayed due to administrative issues with funding and a need to revise the protocol to reduce complexity to ensure successful completion by recruited patients. A revised project plan has been developed and a new budget and IRB submission are in preparation.
Terms of Reference 3. Status of harmonization among commercial immunoassays for UA (funded by
NKDEP). The objectives of this project are to: 1) evaluate harmonization among methods for urine albumin
using native human urine samples; 2) assess agreement of routine methods with an LC-IDMS procedure; 3)
evaluate commutability characteristics of JSCC and diluted ERM-DA470k/IFCC reference materials for urine
albumin; 4) evaluate basic performance characteristics of the urine albumin methods; and 5) compare harmonization of urine total protein and creatinine methods. Accomplishments include: Fresh, nonfrozen
human urine samples (343) that had been submitted for routine urine albumin measurement were measured
by 17 routine procedures from 5 manufacturers. Frozen aliquots of each sample were measured by LCIDMS. Preliminary data analysis suggested an approximate 40% difference among medians of the measurement procedures. The reference materials and some supplemented urine samples were also measured.
The data is in the process of statistical analysis and a manuscript will be prepared.
• WG - Standardization of Pregnacy-Associated
Plasma Protein A (WG-PAPPA)
During 2011 ongoing progress towards WG-PAPP A terms of reference included:
Term of Reference: Develop a reference system for standardization of PAPP-A measurement employed as
marker for prenatal screening. Accomplishments include: The participation of five companies (including
funding and reagents) was secured in May 2011. In August 2011, a project agreement was made between
IFCC and the University of Turku, Finland. Company antibodies (2/company) + 8 index antibodies from
Hytest (selected from a previous epitope map study) were tested in all two-site combinations: 18 Mabs - 324
combinations. Various standard diluents from the participating companies and from the University of Turku
were included in the study. The second phase initially intended to be carried out during 2011 - distribution of
preparations of the candidate standard materials to the corporate members - was delayed as 1st trimester
clinical specimens (pools) were not obtained according to the planned schedule. The second phase of the
project will be carried out in 2012.
• WG - Growth Hormone (WG-GH)
Progress by the WG during 2011 continued to be extremely slow with basically no documented accomplishments. SD Chair attempted to communicate with the WG Chair but received no response. SD questioned
Special Supplement to Lab Medica International • 23
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2011 Annual Report
whether there is a need for standardization in this area. SD decided to terminate WG with the intent to reactivate group at some future time when a new chair can be identified and specific Terms of Reference can be
established.
• WG - Standardization of Insulin Assays (WG-SIA)
During 2011 ongoing progress towards WG-SIA terms of reference included:
Term of Reference. Improve the standardization of assays for insulin by the development of a candidate reference method and materials. Accomplishments include: A letter from SD and WG Chairs was sent in July
to IFCC corporate members soliciting USD 10,000 contributions to support the next phase of work to develop a complete reference system for insulin that will be listed by JCTLM. Engaged a laboratory (Albert Einstein
Medical School, USA) to establish and perform the IDMS reference method procedure for insulin. Validation
of the Einstein RMP will against the IDMS procedure at the University of Ghent will be completed in 2012.
Nearly all the serum samples and pools have been collected, processed, and stored as aliquots. These materials will be value assigned for insulin by the IDMS RMP and will be used to sustain the program to harmonize results from manufacturers of insulin assays. The WG-SIA continued active discussions with the NIDDK
supported C-peptide Working Group (Chair Prof. R. Little) with regard to delineating common approaches
and the establishment of a RMP for C-peptide. Continued emphasis on how both groups can achieve their
goals by sharing plans, materials, and activities.
• WG - Standardization of Troponin I (WG-TnI)
During 2011 ongoing progress towards WG-TNI terms of reference included:
Term of Reference 1. Develop a candidate secondary reference measurement procedure and candidate
secondary reference material for cardiac troponin I (cTnI). Accomplishments include: Candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for
cTnI: 1. The ELISA method has been developed. Further work has been done to try to reduce the variation
in imprecision for the chemiluminescence (CL) assay but without success. The current fluorescence (FL)
detection method (CV <5%) will be able to measure all of the medium & high level cTnI patient samples for
the pilot study but only a quarter of low level samples. NIST will try the CL method on their new plate reader. 2. The higher-order cTnI method has been transferred to CCQM (Consultative Committee for the Amount
of Substance) network laboratories in 2011 as part of their NMI work. Candidate Secondary Reference
Material for cTnI: The WG has developed a pilot study protocol to investigate the feasibility of preparing a
commutable and stable secondary reference material for cTnI by use of serum pools. The study will involve
NIST, NPL, University of Maryland, and industry. Patient samples have been collected by University of
Maryland and the pools prepared at NIST. Samples & pools have been dispatched to participating labs in the
USA and overseas. The final study protocol was rewritten and will be sent out to labs with samples for analysis to be completed by the end of January 2012. Samples will be analyzed at NIST & NPL once the cRMP
is ready. The pilot study will provide information about: 1) current degree of results harmonization between
commercial cTnI assays and comparability with the cTnI cRMP; 2) commutability of cTnI serum pools versus
patient samples used in routine practice; 3) stability of the pools in all assays; and 4) possible presence of
interferences. A preliminary data analysis will be done to obtain a general assessment prior to determination
of acceptance criteria for commutability, etc.
The POINT/COUNTERPOINT article concerning troponin I standardization appeared in Clinical
Chemistry online September 22, 2011 - POINT: Put Simply, Standardization of Cardiac Troponin I Is
Complicated. Robert H. Christenson, David M. Bunk, Heinz Schimmel, and Jillian R. Tate, on behalf of the
IFCC Working Group on Standardization of Troponin I† - COUNTERPOINT: Standardization of Cardiac
Troponin I Assays Will Not Occur in My Lifetime. Fred S. Apple. The articles are planned for publication in
the January 2012 issue of Clinical Chemistry.
Term of Reference 2. Testing for cTnI standardization and clinical validation by comparison with validated
commercial assays in a round robin study. Accomplishments include: There was no activity relevant to this
term.
Table of Analytical Characteristics. WG-TNI assumed responsibility for maintaining up to date information
on the IFCC Website in the table of “Analytical characteristics of commercial and research high sensitivity
cardiac Troponin I & T assays per manufacturers.” Table is linked to by European clinical societies so it is
important to keep information current. WG also keeps the BNP table up to date. The updated Troponin table
reports units in µg/L and ng/L. The WG proposes reporting units of troponin in ng/L only. The next update of
the Troponin table is planned for 2012.
• WG - Allowable Error for Traceable Results (WG-AETR)
During 2011 ongoing progress towards WG-AETR terms of reference included:
Term of Reference 1. To define clinically acceptable limits for metrological traceability of specific analytes.
Accomplishments include: The WG is considering various ways to define clinically acceptable limits and
has decided to initially work on analytes that have a traceability chain with well-defined individual steps. The
WG considered the approach, which uses biological variation and although this is the preferred approach, in
practice it is not feasible as the limits are too tight for use by manufacturers. The WG aims to develop limits,
which are acceptable for use in a traceability chain and not only theoretical limits.
Term of Reference 2. To cooperate with manufacturers, regulatory bodies and end-users to work towards
patient results being traceable to higher order reference materials and methods. Accomplishments
include: As part of developing allowable errors, the Chair again contacted all the major companies (previously done in 2010) asking how they define their in-house limits for the traceability chain. Specifically the
request was for information on how the companies set reject limits for the various steps in the chain. Replies
were received from 4 major manufacturers but from the responses it was not possible to derive a single consistent process.
Term of Reference 3. Harmonization of patient results independent of assay platform, manufacturer or testing laboratory. Accomplishments include: There was no activity relevant to this term.
• WG - Harmonization of Autoantibody Test (WG-HAT)
During 2011 ongoing progress towards WG-HAT terms of reference included:
Term of Reference 1. To evaluate what are the main causes of variability for a number of diagnostically critical autoantibodies. Accomplishments include: Three main areas for variability in autoimmune serology
testing have been identified for investigation. 1. The antigen - and the variation in antigen preparations
between different reagent producers. 2. The antibody - and the variation between the standard antibody
preparation used to calibrate the various assays and the difference between the various calibrant materials
and the samples being analyze and 3. The methods used for autoimmune serology testing. The HAT-WG
addressed the antibody preparations used in the assays.
IFCC
Term of Reference 2. To identify autoantibodies where a common calibrator could reduce the interassay variability. Accomplishments include: The WG identified the following autoantibodies as candidates for common
calibration: .IgG antibodies to proteinase III; IgG antibodies to myeloperoxidase; IgG antibodies to glomerular
basement membrane; IgG antibodies to cardiolipin and beta-2 glycoprotein 1; and IgG antibodies to cyclic citrullinated peptides.
Term of Reference 3. To identify or produce commutable materials that could be used as interim calibration
material for autoantibody assays. Accomplishments include: The WG has concentrated on developing
materials for IgG antibodies to myeloperoxidase and running a preliminary commutability study. The IRMM
produced 18 candidate materials in total - a combination of different plasmaphoresis samples and affinity
purified IgG antibodies to myeloperoxidase and prepared in a variety of ways. This was specifically to
address the impact of preservatives, freeze-drying, and freezing. The commutability feasibility study was
done at St. George's using 29 anonymized patient samples. Results suggest that there is clear potential for
harmonization of results using a common reference material.
Term of Reference 4. To produce well-characterized pure antibody preparations with known concentration
and identity and use these to transfer values to a matrix preparation. Accomplishments include: There was
no activity relevant to this term.
• WG - Quality Specifications for Glucose POCT (WG-GPOCT)
During 2011 ongoing progress towards WG-GPOCT terms of reference included:
Term of Reference. To investigate the quality specifications required for glucose PoCT meters as glucose
testing is used in a wide variety of health care settings including: Hospitals; General practice/Physicians
Office; Specialists; Ambulances; Air Ambulances; Patients/Caregivers; Nursing Homes; Population
Surveys. Accomplishments include: The WG agreed that the group would focus on glucose testing performed in the intensive care/critical care unit. This setting was chosen first as it potentially poses the highest risk to patients if not performed properly. A literature search for relevant papers was undertaken by
each group member. Results from the literature search established that this work had not yet been performed and therefore the WG should address this gap in the literature. A meeting with FDA officials was
held to review the work planned by the WG. The FDA was extremely positive with the work planned by the
IFCC working group. FDA has agreed to work with the WG on this issue and potentially have one of its
staff sit in on the WG.
WG has planned an initial paper titled “Glucose meters - Does one size fit all.” The paper will discuss:
- Use of meters in different clinical settings - guidelines that are currently available from different associations - interfering substances and patient populations they will affect - and introduce a checklist to assist
with meter selection. This paper will also emphasize that good education is paramount to achieving good
results no matter how good the meter performance is.
• WG - Quantitative Mass Spectrometry Proteomics (WG-cMSP)
This was a newly formed WG in 2011. The terms of reference include:
Term of Reference 1. To review the state of the art in quantitative proteomics and to evaluate the capacity of
different analytical (and preanalytical) approaches to play in the future a significant role for clinical biology.
Term of Reference 2. To evaluate the specification and the need for reference materials for quantitative proteomics applied to clinical biology. Accomplishments include: To realize these terms of reference the WG
decided to write a general review (“white paper”) on the subject (see sections below). First of all, to make the
distinction with regular clinical proteomics, which deals mostly with biomarker discovery and validation, and
with the different applications of Mass Spectrometry in clinical biology (bacteriology etc.), the WG choose the
appellation “quantitative Clinical Chemistry Proteomics” (qCCP). qCCP will refer to the body fluid mass spectrometry quantitative measurement of peptides and proteins for clinical diagnosis. The review on qCCP will
have the following sections: 1) Reference material: 2) Sample preparation: 3) MS approaches: 4) Criteria to
select analytes for qCCP: 5) Review of the literature.
Term of Reference 3. To design of a Quality Assurance/Quality Control (QA/QC) Program and to select a
small series of analytes to be the subject of a future multisite validation study
Accomplishments include: A shortlist of candidates included: Apo A1 / Herceptin / PTH / Renin /
Haemoglobin / Hepcidin.
Hepcidin was selected in the first place since it can be measured in different body fluids, with different
MS approaches, ELISA and reference RIA method exist for comparison, and it has a clinical interest.
However, this analyte is already the subject of a thoughtful multisite evaluation that includes MS approaches (see Kroot, J. J., H. Tjalsma, et al. (2011). "Hepcidin in human iron disorders: diagnostic implications." Clin
Chem 57(12): 1650-1669). Therefore, the WG is considering Apo A1 /ApoB for a multisite evaluation of qCPP.
Ian Young, SD Chair
EDUCATION AND MANAGEMENT DIVISION (EMD)
The committees and working groups of the Education and Management Division (EMD) have worked hard
during the year to improve educational resources for IFCC member countries, particularly those developing
their laboratory medicine services. The emphasis has continued to be on analytical and service quality and
on emerging technologies.
The EMD Executive Committee (EC) met twice during the year, in January in Orta San Giulio, Italy, and
in Berlin during the 21st IFCC Congress. All the members participated to the two meetings except Rolf
Hinzmann who was unable to be present in Berlin. The contributions of all the members were always very
productive.
Much of the work of the EMD requires both EMD Officers and international scientific experts to travel to
conduct workshops and make presentations at congresses in IFCC member countries. To finance this, we
are dependent on the generous sponsorship of our Corporate members, particularly Abbott Diagnostics,
which provides very generous support for the Visiting Lecturer Program (VLP), very ably coordinated by
Leslie Lai. During 2011, the following countries have benefited of VLP funding; Philippines, Argentina,
Romania, Vietnam, Kenya, Uruguay, Nepal, Dominican Republic, and Poland. Several VLPs are already
scheduled for 2012 and we would welcome applications from National Societies for visiting lectureships for
the coming year. These should be made to Leslie Lai, who is able to provide advice on the process, lecturers, and topics.
The EMD remains committed to the project for developing quality competence in medical laboratories
(DQCML), chaired by Michael Thomas who has been reappointed for the second term as a Consultant and
Chair. The DQCML sponsored the visit of Dr. Huy Quang Vu to the RCPA Chemical Pathology Quality
Assurance Programs Office in Adelaide, Australia in July. Janice Gill tutored him and his colleagues on the
practical aspects of organizing an EQA scheme and she will provide ongoing consultation to the Vietnam
Center for QA/QC.
Elizabeth Frank, Chair of the Committee on Clinical Laboratory Management (C-CLM), with T. Badrick, J.
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IFCC
2011 Annual Report
Smith, and L. Lai organized a QA workshop in Manila in the Philippines in March. J Hicks worked a lot with
the African Federation of Clinical Chemistry and organized a VLP in Kenya in September.
The EMD welcomes applications from member Societies to host workshops on all aspects of laboratory
quality.
Travel Scholarships were approved for attendance at the IFCC WorldLab in Berlin. Only 8 out 12 were
able to come because of visa problems.
A meeting of the DQCML project team was held in Berlin on 16 May, during the IFCC WorldLab. It was
interesting to hear updates on initiatives organized through the project, in particular, the activity in the Africa
region, and in Nepal. Representatives of National Societies interested in the work of the different projects
should contact Silvia Cattaneo.
Following the success of the second course on molecular biology (C-CMBC) to be held outside Milan, in
Uruguay in December 2010, a third course has been held in Guatemala in December 2011. This course was
very successful and for the first time, there was a student from the previous course, Maria Eugenia Schroder
from Uruguay, who was briefed to transfer her experience of the course to the new participants.
It is the intention of the EMD that a course should be held on an annual basis, in a country, which has
identified an educational need, to enable development of molecular biology services in their clinical laboratories. The course is extremely comprehensive and includes precourse training for a young scientist from the
host country, in the laboratory of the Chair of the C-CMBC, Michael Neumaier, in Heidelberg, Germany. The
success of these courses is a major achievement for Michael and his hard work and personal commitment
to the initiative is recognized and much appreciated by the EMD.
C-CMBC organized the Symposium “Biobanking and laboratory Medicine” during the IFCC-WorldLab in
Berlin and held a committee meeting on May 16.
Andrea Ferreira-Gonzalez from Richmond University is a new member and Evi Lianidou, and Kenji
Izuhara were reappointed for second terms of office.
Committee on Analytical Quality (C-AQ): Janice Gill and Egon Amann organized a teleconference on
March 2011 and a full day meeting in Berlin on Sunday, May 15. An IFCC Visiting Lecture Program was held
in Nepal from November 22-24, 2011. The program was entitled the International Workshop on Clinical
Laboratory Management and there were 160 attendees. The VLP team was Janice Gill (Australia), Elizabeth
Frank (India), and Clare Murphy (New Zealand) with the assistance of Dr. Ashpal Singh (BD India).
The IFCC EMD, through Dr. Leslie Lai has arranged for Randox to sponsor a number of Nepali laboratories with their RIQAS external quality assessment scheme. Dr. Huy is currently setting up an EQA program
for 120 labs using previous purchased EQA material.
The Committee for Evidence-Based Laboratory Medicine (C-EBLM), under the chairmanship of Robert
Christenson, has continued its excellent work in the provision of presentations and workshops on EBLM techniques. Workshops and lectures involving C-EBLM members were held in Berlin by Dr. Christenson on cardiac markers and in Atlanta in conjunction with AACC's EBM committee on July 27.
Hernan Taie has continued to be very active, and has participated and led a number of educational sessions throughout South America and of Central America.
To spread knowledge of the concepts of EBLM more widely, The Committee is hoping to use the new
IFCC Website as a means to deliver training in evidence based laboratory medicine.
The Committee on Education and Curriculum Development (C-ECD) was closed at the end of 2010.
It is inevitable that distance learning will become a major educational tool for the EMD in the future; for
this reason after a discussion in Berlin, a new Committee on Distance learning has been planned to start
in 2012.
The Committee on Clinical Laboratory Management (C-CLM) completed the Manila workshop in March
2011. Elizabeth Frank, with T. Badrick, J. Smith, and L. Lai organized a very successful QA workshop and a
workshop on clinical interpretation. Two new members of the C-CLM, Barbara Goldsmith (USA) and Ravi
Erasmus (ZA) have been welcomed to the Committee and a committee meeting was held in Berlin in May,
at which there were extensive discussions on future directions for its work. Elizabeth Frank was involved in
the International Workshop on Clinical Laboratory Management in Nepal from 22-24 November 2011. The
second C-CLM monograph, Quality of Management & Quality of Analysis, prepared by past and present
members of the C-CLM and C-AQ is at the review stage.
The work of the Working Group on Bone Marker Standards in Osteoporosis (WG-BMS) is now complete
with the publication of their paper in Clinical Chemistry and Laboratory Medicine, highlighting the IFCC and
IOF position on bone marker standards. The recommendations of the WG have been widely publicized in
national and international journals. The next phase of the project will be the standardization/harmonization of
the measurement of the two reference standard bone markers, namely s-CTX and s-PINP and this new WG
will be within the Scientific Division.
Working Group on Laboratory Errors and Patient Safety (WG-LEPS): After the meeting of the WG Chair,
Mauro Plebani with the EMD-EC in Lago d'Orta at the beginning of 2011 and the recommendations received
by the IFCC President, the activities of the WG have been publicized, to spread information on the work on
quality indicators and to appoint some leaders in each country to make possible a better interaction at a
national level (Brazil, Turkey, Ireland, China, Croatia, Serbia). Dr. Plebani delivered several lectures on this
topic (UK, USA, Brazil, Turkey, Ireland).
Flow cytometry (WG-FC): Ulrich Sachs is the new Chair of this working group. He has agreed to work with
Beckman Coulter to organize future flow-cytometry courses. Next course will be held during the spring in
Leipzig, Germany.
At the end of 2011, Janet Smith completed her second term of office as EMD chair and I would like to take
this opportunity to thank her for their commitment to the work of the EMD over many years and to help me
so much in this transitional phase. I would also like to thank all members of EMD Committees and Divisions
for their hard work and support during the year.
Maurizio Ferrari, EMD Chair
COMMUNICATION AND PUBLICATIONS DIVISION (CPD)
Activities and Reports
7
COMMITTEES
Committee - Public Relations
The IFCC promotional brochure was updated after the elections in Berlin and is/will be available in nine
languages (Arabic, Chinese, English, French, German, Italian, Portuguese, Spanish, and Russian.) Print
copies in these languages are available in the IFCC office for distribution at different meetings. A Turkish version will be prepared in time for the 2014 IFCC in Istanbul.
An IFCC laboratory medicine slide kit (PowerPoint presentation) for the general public, describing the
role and value of laboratory medicine, has been developed and is available for use by all IFCC officers and
National Societies.
A proposal for an IFCC Task Force on the Value of Laboratory Medicine in Healthcare and in Clinical
Outcomes was developed and submitted to the EB. It was approved in concept but some changes were
requested. The proposal will be finalized in early 2012 and be resent to the EB.
A PR brochure for the general public is being developed and is expected to be completed in 2012.
Joint IFCC-“Labs are Vital” PR Initiative - The PR committee has been interacting with the managers of
the LAV program and two of the committee members are members of the KOL(key opinion leaders) board of
the LAV program. The mission of the LAV program has been modified to have a particular emphasis of developing evidence for the vital role of the clinical laboratory in the healthcare delivery system. Labs are Vital
advisory board is getting more active.
Working Groups
Working Group - eJIFCC
This is the last year of Prof. Grazyna Sypniewska's term as chair of the eJIFCC Working Group (eJIFCC
Editorial Board) and Editor in Chief of the eJIFCC Editorial Board). Prof. Gabor Kovacs (Hungary) will be the
next chair/Editor in Chief. The publication schedule, consisting of 4 issues per year (see Appendix 1), is being
adhered to. Starting last year there are no longer themes to the issues, because of the difficulty in obtaining
enough manuscripts on a selected subject within a reasonable time, rather the content is now oriented
toward practice issues and audits. This decision is being reviewed in light of the upcoming changes in the
Editorial Board and that it is anticipated that the new publisher will work with the IFCC in developing, promoting, indexing, and building impact factor of the eJIFCC.
Working Group - IFCC News
WG membership consists of representation from Belgium, Brazil, Canada, Cyprus, Malaysia, Mexico, Morocco,
Nepal, Nigeria, Poland, Slovenia, South Africa, Spain, Tunisia, Uruguay, and Vietnam. Additionally, there are now
National Society liaisons from Australasia, Serbia, UK, USA, Paraguay, and Vietnam. Members are required to
submit at least two articles per year. The schedule of six issues per year has been maintained with good content
(see Appendix 2). However, the shortage of opinion, position papers, and letters to the editor still remains somewhat problematic. Letters have been sent to the chairs of divisions and committees reminding them to provide
news items, along with the submission deadlines for the various issues.The relationship between IFCC and
LabMedica International for the print publication of IFCC News continues to be smooth and without issues.
Working Group - Internet and Distant Learning
There were over 104,000 visits to the IFCC Website during 2011, with 32% being return visitors. The first
phase of the launch of a new Website occurred on December 1. It is based on a content management system and has a cleaner look and easier navigation. Maintenance/file updating has been simplified. Some of
the archive files still need to be transferred. The C-NPU database has been placed on the Website and a
special search function is being developed. There is a scrolling banner on the Website homepage that contains the logos of the Corporate Members, which are hotlinks to their Website. The second phase of the
Website launch is plan to include a: 1) IFCC Digital Library, 2) NPU database query engine, 3) IFCC Store
with a payment function, and 4) controlled access (protected) areas. The C-EBLM database has to be rebuilt.
A Wikipedia entry for the IFCC was created in December in English and now acts as the second major
contributor of Website traffic (after search engines).
IFCC Facebook and LinkedIn pages have been established and it is expected that these will be used as
forum sites for the IFCC, rather than the Website.
Siemens/IFCC Distance Learning Program
The first part of the multipart distance learning program on developing a quality system in line with ISO
15189, based on the EMD workshop, has been developed and is being reviewed by the EMD.
Working Group - Spanish (Ibero-American) Nomenclature and Translations
The WG is working very diligently to continuously refine and update the RIA section.
Reports on Publications
Documents from Committees and Working Groups
The database (available on the Website) continues to be updated, as publications are forthcoming. See
appendix 3 for the list of 2011 publications.
Books
The 2012-14 IFCC Handbook is being prepared and will be distributed on a CD, as well as being available
on the IFCC Website. Revision and updating of the "Silver Book": Compendium of Terminology and
Nomenclature of Properties in Clinical Laboratory Sciences (IUPAC and IFCC Recommendations) is expected to be completed and published in mid 2012.
Journals
This was the second year of Ellis Jacobs' second term as CPD chair. Three face-to-face committee meetings were held (Milan in January, Berlin in May, and Toronto in September). A meeting was held with editors and publishers of National Society biomedical journals at WorldLab 2011 in Berlin. There was a joint
CPD/EMD symposium at WorldLab2011 on eLearning and distance education, and a CPD symposium on
peer review and ethics in publications at the COLABIOCLI congress in Punta Cana, DR. Additionally, the
entire CPD EC presented in a special half day IFCC Symposium that was held in Toronto, CA. A new
IFCC Website was launched in December. A Request for Proposal for publishing the eJIFCC as the official journal of the IFCC was sent. The WG-Internet and Distance Learning will be closed at the end of
2011 and be replaced by a Committee on Internet and eLearning (C-IeL) that will start in 2012 with Peter
Vervaart as chair.
Meeting of National Society Journal Editors / Publishers
This year's meeting was held in Berlin, Germany at the International Congress of Clinical Chemistry. Nine
society journals and one publisher were represented at the meeting. There were discussions concerning copublications/copyright issues, free (open) access, electronic vs. print publishing, and ethics policies.
Clinical Chemistry & Laboratory Medicine (CCLM)
The contract with Walter deGruyter relative to CCLM being the official journal of the IFCC expires July 22,
2013. Currently, all IFCC documents are available free on the CCLM Website. Free access to full online version is available for all NR & PR of member societies, CR, EB, DC, and IFCC Regional presidents. There are
Special Supplement to Lab Medica International • 25
8
2011 Annual Report
also reduced-rate subscriptions available for the paper CCLM through National Societies. A request for proposal for publishing the eJournal as the official journal of the IFCC, rather than an existing journal, was sent.
Corporate Member Activities
The new corporate representative, Bruce Jordan (Roche Diagnostics), has been a very active participant in
the CPD EC meetings and was a presenter at the symposium in Toronto. He has been working with the WGIDL in helping get distance-learning content.
Membership
Gabor Kovac has been appointed to replace Grazyna Sypniewska at the end of her term. Call for
Nominations for Vice Chair and IFCC News editor, with terms starting in 2013 have been sent out.
Ellis Jacobs, Chair CPD
IFCC TASK FORCES
• TASK FORCE FOR YOUNG SCIENTISTS (TF-YS)
The aim of IFCC Task Force for Young Scientists (TF-YS) is to ensure that young scientists make a significant and growing contribution to the activities of IFCC and to the promotion of laboratory medicine at the center of healthcare.
TF-YS projects
Core-members are interacting and reviewing the evolution of the TF-YS projects mainly through Skype conference call (bimonthly). Furthermore, different meetings with some core-members, members and the IFCCEB Liaison Dr. B. Gouget were organized in Berlin (Euromedlab 2011), Rabat (SMCC 2011), Atlanta (AACC
2011), and Paris (JIB 2011). and in Anaheim within the AACC annual meeting in July.
Networking and identification of young scientists
One of the most important goals of the TF-YS is to contribute to a part of the future of IFCC through the identification of young scientists (YS) who may develop into future experts capable of leading IFCC Divisions,
Committees and Working Groups and becoming IFCC Officers.
In 2011, the TF-YS proposed several networking sessions to stimulate other YS from national societies and
corporate members to participate to IFCC and TF-YS projects. Sessions were held in Rabat (SMCC 2011),
Berlin (Euromedlab 2011), Atlanta (AACC 2011), Bucarest (BCLF 2011), Paris (JIB 2011), and Gwalior (ACBI
2011). These sessions have allowed identifying young scientists, from different fields of expertise, in 35 countries. YS have thus been identified in Romania, Poland, Morocco, Algeria, Tunisia, China, Nepal, United
Kingdom, Ireland, Singapore, Turkey, Albania, South Africa, Brazil, Korea, Malaysia, India, Egypt, Ukraine,
Serbia, Venezuela, Mexico, Canada, Greece, Democratic Republic of Congo, Qatar, China, Italy, Austria,
Australia, Czech Republic, Russia, France, USA, and Belgium. A clear strategy for our task force is to federate these new forces and to ask those YS to create groups of YS in their respective country/area.
Exchanges have also been initiated with other groups of young scientists: Young Scientists of Ireland,
Young Active Researchers Endocrinology, Belgian Young Cardiologists Club, and Young Scientists of the
Asian Society of Autoimmunity.
Our task force is also maintaining active the group created on Linkedin one year ago is also precious to
disseminate the information of these networking activities but also to interact with YS and catch their wishes. This Linkedin group is still growing.
IFCC
Seccombe and Graham Jones [via pre-taped slide presentation]). An outcome of this meeting was the establishment of the Mexican Steering Committee for Early Detection of Renal Disease.
A joint symposium of the IFCC and WASPaLM Task Force was presented at the IFCC meeting in
Berlin. Symposium Title: Chronic Kidney Disease - Developing a National Testing Program. Speakers:
Flavio Alcantara: CKD - A Global Clinical Perspective. David Seccombe: Why a national program for CKD
testing? Graham Jones: Key factors in successful national CKD programs. The contents of the talks were
submitted to the Conference organisers for inclusion in a publication arising from the conference.
The Task Force had a face-to-face meeting in Berlin to coincide with the IFCC meeting with a number of
guests present.
Graham Jones, TF Chair
• TASK FORCE ON ETHICS - (TF-E)
The TF held an interactive educational session on ethics during WorldLab in Berlin. Attendance was limited, but above the average attendance at the concurrent sessions held at that time. Ethical issues in
publishing were discussed. The focus remained on publication ethics for half of the workshop and then
moved to broader areas of ethics in laboratory medicine. Participants were concerned that ethics
receives too little attention and is not even covered in textbooks of clinical chemistry. The demands of
laboratory medicine lead clinical chemists to focus on keeping up to date on new technical and medical
developments at the expense of learning about ethics. The wide range of cultures in IFCC leads to differences in approach to ethics.
Resources on ethics to be made available on IFCC Website
The TF will provide on the IFCC Website examples of available resources in ethics. The group identified topics for inclusion on the Website: resources for publication ethics (e.g., links to ICMJE, COPE, Clin Chem),
conflict of Interest Policies of organizations (e.g., AACC), codes of Ethics, Clinical Chemistry and Laboratory
Medicine ethics.
Conflict of interest (COI) policies
The TF has recommended a policy on conflict of interest (COI) for use within IFCC.
Policy on relations with industry
The relations of professional societies with industry are being scrutinized by media and governments.
Policies on these relations have been developed by individual companies in the IVD industry, by industry
associations (such as AdvaMed and EDMA) and by professional societies. The sentiment of the TF was that
IFCC should have an explicit policy.
Statement on publication ethics
The TF has discussed a statement on publication ethics
David Bruns, TF Chair
• TASK FORCE ON IMPLEMENTATION OF
HEMOGLOBIN A1c STANDARDIZATION (TF-HbA1c)
Publication of articles
The exchanges between TF-YS members have also provided written materials discussing needs and visions
about laboratory medicine future. Based on all the collected information, a new manuscript about the YS environment is in preparation. Several articles have been published by YS in the IFCC news as well as in the
newsletter of the congresses were a TF-YS session was held.
The TF met in Berlin and agreed on a number of projects:
• A questionnaire about national experience would be devised: This has been drafted and will be circulated using Survey Monkey.
• A short position paper would be drawn up outlining the traceable link between the IFCC and NGSP networks. This will be sent to a Clinical Journal; JAMA has been approached and are interested in taking it.
• A full review will be written on HbA1c outlining the current situation and the future (Analytical and
Clinical). Background work for this paper is well underway; it will be further discussed at the International
Diabetes Federation.
This has been a very successful and productive year; communication is important and this year both GJ
and CW have had the opportunity to talk about IFCC standardization at several international meetings. There
is a lot of interest especially from Asia with applications from three laboratories to become IFCC reference
laboratories.
Web-based activities
Web-based activities are important for the appropriate growth and efficiency of the TF-YS but were lacking
in 2011. As the new IFCC Website has been released, we hope that 2012 will allow us to use this tool more.
• TASK FORCE ON CLINICAL APPLICATIONS
OF CARDIAC BIOMARKERS - (TF-CB)
Garry John, TF Chair
Damien Gruson, TF Chair
• TASK FORCE ON PEDIATRIC LABORATORY MEDICINE (TF-PLM)
The purpose of this Task Force is to develop procedures and processes to improve the diagnosis and management of patients from birth (or even before) to adolescence.
The International Conference of Pediatric Laboratory Medicine (ICPLM) 2011 was held in Berlin, May 1315, 2011, with more than 330 registered participants, 4 Plenary Lectures, 10 Symposia with more than 30
speakers, and over 90 Scientific Posters. With more than EUR 60,000 in sponsoring money and more than
EUR 50,000 from registrations, it was also a financially successful congress.
A Task Force Meeting was held during the AACC Annual Meeting, Atlanta (GA, USA; July 27), where
ICPLM 2011 was evaluated, and first planning for ICPLM 2014 was started.
Klaus P. Kohse, TF Chair
• TASK FORCE ON PHARMACOGENETIC - (TF-PG)
The Task Force had a face-to-face meeting in Berlin to coincide with the IFCC meeting with a number of
guests present.
A draft version TPMT guideline was sent out for review to committee members and to representative of
the British association for Dermatology. Two feedbacks were obtained. The TF extended international contacts regarding Pharmacogenetics. TF also obtained information on current status and potential applications
from pharmacogenetics through contacts and presence during international Pharmacogenetics meetings. TF
created contacts with other societies, which aim for guideline development on Pharmacogenetics. The TF
Chair Ron van Schaik was appointed as advisory member EMA Working group Pharmacogenetics.
TF promoted TF-PG initiative at several meetings (a.o. IFCC World-lab-Berlin, IATDMCT-Stuttgart,
SBAC-Curitiba, Turkey PGx meeting-Bodrum, PharmSciFair-Prague, Pharmacogenomics meeting-Welcome
Trust Hinxton, NVKC-Utrecht, NACGG-Utrecht).
Ron HN van Schaik, TF Chair
• IFCC and WASPaLM TASK FORCE ON CHRONIC KIDNEY DISEASE (TF-CKD)
Two members of the Task Force contributed to a symposium on CKD in Mexico on January 8, 2011, (David
TF-CB include 3 cardiologists (Jaffe, Lindahl, Möckel), 2 ED physicians (Hollander, Than) and 5 laboratorians (Apple, Collinson, Chan, Ordonez, Plebani) and all them are also Editors or members of Editorial Boards
of Clinical Laboratory, Cardiology or Emergency Medicine journals and members of Committees working in
similar objectives than those of the TF-CB. Accordingly, the TF composition seems quite appropriated for
addressing the IFCC objectives of directing laboratory activities towards the patients and promoting publications and educational materials. The TF has also eight companies as corporate members. The companies
share the TF aim of developing educational materials for the medical community and offer both economical
and logistic support for reaching the TF aims.
The TF met in Berlin (IFCC EFCC EuroMedLab Berlin), Atlanta (AACC meeting), and Paris (European
Society of Cardiology meeting).
Current Projects
The first project will be the development of educational materials about high-sensitive troponin uses, since
they are being introduced in the clinical practice without an extensive knowledge of their pros and cons.
Lab issues production
Two of the TF members were committed by Clinical Chemistry Journal to write a paper analyzing the lab
issues of high-sensitivity troponin (hs-Tn) assays for a special issue on Cardiac Biomarkers (“Analytical
Characteristics of High-Sensitivity Cardiac Troponin Assays”), written by Fred S. Apple and Paul O. Collinson
on behalf of the IFCC Task Force on Clinical Applications of Cardiac Biomarkers will appear in the monographic issue of January 2012 of Clinical Chemistry.
Jorge Ordoñez-Llanos, TF Chair
IFCC Annual Report 2011 has been compiled and edited by Päivi Laitinen, Secretary of IFCC from the
reports of the respective IFCC Officers and Regional Federations.
FOR MORE INFORMATION ON THE IFCC CONTACT:
IFCC Office • Via Carlo Farini 81, 20159 Milan, ITALY
Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846
e-Mail: [email protected] • Web: www.ifcc.org
Special Supplement to Lab Medica International • 26
LabMedica
for daily laboratory medicine news click to www.labmedica.com
NIST Standard Will Help Diagnosis, Treatment of Cytomegalovirus
new clinical Standard Reference Material
(SRM) will help healthcare professionals more
accurately diagnose and treat Cytomegalovirus
(CMV), a common pathogen that is particularly dangerous for infants and persons with weakened
immune systems.
If a CMV infection becomes dangerous, antiviral
agents can be used to moderate the impact. Many
of these compounds are toxic, so the physician must
know the severity of the infection – a measure
known as viral load (number of virus copies per
microliter of blood) – to prescribe the optimal
dosage and duration of treatment.
A
Test Identifies Early Signs of
Mucopolyscaccharidoses
team of scientists has developed a simple, reliable test for identifying biomarkers for
mucopolysaccharidoses (MPS), a group of inherited
metabolic disorders that are currently diagnosed in
patients only after symptoms have become serious
and the damage possibly irreversible.
The scientists developed an innovative method
to detect carbohydrate structures specific to glycosaminoglycans in the cells, blood, and urine of
MPS patients. The biomarker assay identifies all
known forms of the disease.
The effects of MPS range from mild to severe. It
is caused by the absence or malfunctioning of a lysosomal enzyme required to break down and recycle
complex sugar molecules called glycosaminoglycans, which are used to build bone, tendons, skin,
and other tissues. If not degraded and removed, glycosaminoglycans can accumulate in cells and tissues, resulting in progressive, permanent damage
affecting appearance, physical abilities, organ function, and often mental development in young children.
There are 11 known forms of MPS, each involving a different lysosomal enzyme. A number of treatments exist, including enzyme replacement therapy
and hematopoietic stem cell transplantation, but
efficacy depends upon diagnosing the disease and its
specific form as early as possible.
That has been problematic, said Jeffrey D. Esko,
PhD, professor in the Department of Cellular and
Molecular Medicine and codirector of the
Glycobiology Research and Training Center at
University of California (San Diego, CA, USA;
http://cmm.ucsd.edu).
“The typical time from seeing first symptoms to
diagnosis of MPS is about three years. Since the early
signs of disease are common childhood issues like ear
infections and learning disorders, the disease is usually not immediately recognized,” Prof. Esko said.
Prof. Esko is collaborating with Zacharon
Pharmaceuticals (San Diego, CA, USA; www.
zacharon.com), a biotechnology company, to develop a commercial diagnostic assay for differentiating
forms of MPS from urine and blood samples, a
screening test for newborns, and a tool for measuring the biochemical response of MPS patients to
existing and novel therapies.
The findings were published online January 8,
2012, in the journal Nature Chemical Biology.
A
27
LabMedica International
April/2012
The current means of measuring viral load is to
use polymerase chain reaction (PCR) to amplify a
region of the CMV gene and then use a calibration
curve to estimate the number of virus particles in
the original sample. Accuracy of these measurements can vary greatly from one test facility to
another, as there are many different PCR protocols
used to determine viral load, including commercial
and “in-house” laboratory assays.
The new [US] National Institute of Standards and
Technology (NIST; Gaithersburg, MD, USA;
www.nist.gov) reference, SRM 2366, provides a
standardized CMV DNA. Consistency of the viral
DNA in the standard was ensured by manufacturing
it in Escherichia coli bacteria. These E. coli cells
each contain a copy of the CMV genome in a “DNA
construct” – an artificially constructed segment of
nucleic acid that codes for a specific product, in this
case, CMV DNA. The DNA copies made by this E.
coli cell culture can then be purified and quantified
LINKXPRESS COM
using digital polymerase chain reaction (PCR).
SRM 2366 consists of three solutions, each with
a specific concentration of CMV DNA copies per
microliter: 420, 1,702, and 19,641. These are
designed to qualify prepared calibration samples.
They also can be used as quality control samples for
diagnostic equipment. For added traceability, the
SRM certificate of analysis includes the genetic
sequences of the nine CMV genome regions copied
for the standard.
CMV is found in 50% to 80 % of the population.
CMV generally remains latent in an infected person
unless certain conditions trigger its activation. CMV
poses a significant health risk to people who are
immunocompromised and babies who receive the
virus from their mothers before birth. Congenital
CMV infections cause more long-term problems and
childhood deaths than many other prenatal disorders including fetal alcohol syndrome, Down syndrome, and neural tube defects such as spina bifida.
LMI-04-12 127
PRODUCT NEWS
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results requiring multilevel analysis.
The URIT-5500 is a 5-Part-Diff automatic analyzer that allows for walkaway automation, high efficiency, and
accuracy. Other key benefits include
double mode for WBC counting, high
precision sample rotary valve, helium-neon laser light, and a throughput of up to 110 samples per hour.
The atomizing nozzles generate a
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LMI-04-12 212
Centrifugal Speed Affects
Light Transmission Aggregometry
ight transmission aggregometry (LTA) is considered the gold standard for investigating
platelet activity ex vivo, but LTA protocols are not
standardized.
Centrifugation speed is an essential component of platelet preparation in LTA and has yet to
be standardized, which may affect platelet aggregation leading to a potential source of variance in
results.
In a study, conducted at the New York
University School of Medicine (NY, USA;
www.med.nyu.edu) the effect of relative centrifugal force (RCF) intensity on LTA results was
investigated. Ten healthy controls had venous
blood drawn and centrifuged at 150, 200, 300,
and 500 x g for 10 minutes. Cell counts in whole
blood and platelet-rich plasma (PRP) were measured using a hematology analyzer. LTA was performed using 1.0 µM adenosine diphosphate
(ADP) and 0.4 µM epinephrine as an agonist. The
percentage of aggregation was compared at 60,
120, 180, and 300 seconds and at maximum
L
aggregation.
Centrifugation speed was associated
with a statistically significant decrease
in platelet counts and decrease in mean
platelet volume in PRP. Consistently,
platelet aggregation in response to 0.4
µM of epinephrine decreased significantly with increasing centrifuge RCF
at 60, 120, 180, 300 seconds and at
maximum aggregation. Whole blood
and PRP cell blood count were performed using a Sysmex XE-2100 analyzer (Mundelein, IL, USA; www.
sysmex.com). LTA was performed using the
AggRAM light transmission aggregometer, reagents, cuvettes, and stir bars (Helena Laboratories, Beaumont, TX, USA; www.helena.com).
The authors concluded that using different
centrifuge RCF results in changes in PRP properties and LTA. This difference in methodology
gives pause to comparing LTA from studies with
different protocols and may help explain some of
the inconsistencies observed in the field.
Consequently, consideration should be given to
standardize centrifugation parameters in performing LTA. The study appeared in the February
2012 edition of the International Journal of
Laboratory Hematology
Image: The XE-2100 hematology analyzer (Photo
courtesy of Sysmex).
Multiple Candida Species Detected by Molecular Technique
simplified, specific, and sensitive seminested
(PCR) method has been developed to identify medically important Candida species.
Novel primer sequences were designed and
the seminested PCR was capable of detecting a
larger number of Candida species by using
annealing temperatures of either 60 °C or 65 °C
in the second round of the seminested PCR.
At the Universiti Putra Malaysia (Serdang,
Selangor, Malaysia; www.upm.edu.my) scientists
designed species-specific reverse primers (SSRPs)
of 10 Candida species by retrieving at least three
internal transcribed spacer (ITS) gene sequences
of each species. DNA amplification was performed in a MasterCycler gradient thermocycler.
To test the specificity of the method, 27 Candida
A
clinical isolates, 10 Candida American Type
Culture Collection (ATCC; Manassas, VA, USA;
www.atcc.org) strains, six Aspergillus ATCC
strains, one Cryptococcus neoformans clinical
isolate, and one human genomic DNA from an
apparently healthy human volunteer were tested.
After optimizing the PCR conditions on the
MasterCycler thermocycler (Eppendorf; Hamburg,
Germany; www.eppendorf.com), the targeted 10
Candida species showed an expected approximate
size of PCR amplicons after the second round of
PCR with their respective SSRPs. A similar observation was seen when tested on the 27 Candida
clinical isolates of various species in the analytical
specificity testing. The limit of detection for all
Candida species ranged from 0.26 pg to 0.46 pg,
except for Candida guilliermondii and Candida
kefyr where a 10-fold increase in DNA amount
was required.
The authors concluded that the advantages of
the high sensitivity feature of seminested PCR
were successfully applied, while the drawback
usually faced, especially on the limited capability
of detecting more species, was overcome. Its
usage is favorable in invasive types of fungal
infection cases since early rapid detection can be
done. This helps to lessen the rate of drug resistance emergence and the precarious use of costly
and toxic antifungal drugs for prophylaxis and
treatment purposes. The study was published on
December 10, 2011, in the journal Diagnostic
Microbiology and Infectious Disease.
LabMedica International
April/2012
28
LabMedica
for daily laboratory medicine news click to www.labmedica.com
Molecular Assay Compared to Urinary Culture for Congenital Infection
real-time polymerase chain reaction (rt-PCR) assay has been
evaluated to diagnose Cytomegalovirus (CMV) infection in the urine
of neonates. The real-time CMV PCR
was compared with shell vial culture
of neonatal urine, which is referred
to as the gold standard in the diagnosis of congenital CMV infection. A
team of microbiologists at the Leiden
University Medical Center (The
Netherlands; www.lumc.nl) analyzed a series of 340 neonatal urines
received for congenital CMV diagnostics and routinely assessed with
shell vial CMV culture, was retrospectively tested by real-time CMV
PCR. All 25 CMV culture positive
samples and a large random selection
A
of 315 CMV culture negative urine
samples dating from 2001 to 2011
were included in the analysis, irrespective of clinical characteristics of
the newborns.
DNA extraction was performed on
the MagNA Pure LC station using the
Total Nucleic Acid Isolation Kit –
High Performance Kit Roche Diagnostics, (Almere, The Netherlands;
www.roche.nl) and the PCR was carried out using a CFX96 TM real-time
PCR detection system (BioRad; Veenendaal, The Netherlands; www.
bio-rad.com). The proportion of newborns found to be congenitally infected by real-time CMV PCR was 8.2%
(28/340), and 7.4% (25/340) by
rapid culture. When considering
rapid culture as reference, real-time
PCR was highly sensitive (100%),
whereas sensitivity of rapid culture
was 89.3% when considering realtime PCR as reference.
The authors concluded that supported by analytical and clinical data
on CMV DNA detection in neonatal
urine, their results suggest enhanced
sensitivity of recent PCR techniques
when compared to viral culture.
There is considerable rationale to
favor real-time CMV PCR as a gold
standard in the diagnosis of congenital CMV infection. A large-scale study
combining both laboratory and clinical data is required to determine the
exact time frame for sampling of
neonatal urine when using real-time
Elevated Glucose
Associated with Undetected
Heart Damage
levated levels of glycated hemoglobin (HbA1)
are associated with minute levels of the protein
troponin T (cTnT), a blood marker for heart damage.
A high-sensitivity blood test has been used to
detect levels of cTnT showed that the concentrations
were tenfold lower than those found in patients diagnosed with a heart attack. Scientists at the Johns
Hopkins Bloomberg School of Public Health
(Baltimore, MD, USA; www.jhsph.edu) tested the
hypothesis that in persons without clinically evident
chronic heart disease (CHD) or heart failure, chronic hyperglycemia, assessed by HbA1c, would be
independently associated with subclinical myocardial injury measured by elevated cTnT. The cTnT
was measured using a novel high-sensitivity assay;
Elecsys Troponin T (hs-cTnT) with a lower limit of
detection of 3.0 ng/L. Elevated hs-cTnT was defined
as levels above 4 ng/L in a healthy subpopulation,
which were 20 to 70 year old.
The scientists followed 9,662 participants from
the Atherosclerosis Risk in Communities (ARIC)
study. None of the participants had coronary heart
disease or history of heart failure. Higher levels of
HbA1c were associated in a graded fashion with elevated levels of high-sensitivity cTnT. This relationship was present at HbA1c levels even below the
threshold used to diagnose diabetes. Using conventional tests, troponin T can be detected in 0.7% of
the population and is associated with heart attacks
and death. With the high-sensitivity Elecsys
Troponin T test (Roche Diagnostics; Indianapolis, IN,
USA; www.roche-diagnostics.us) low levels of troponin were found in 66% of the study population.
Jonathan Rubin, MD, a lead author of the study,
said, “Our study hints at other potential pathways by
which diabetes and elevated glucose are associated
with heart disease. Mainly, glucose might not only
be related to increased atherosclerosis, but potentially elevated glucose levels may directly damage cardiac muscle.” The study was published on January
31, 2012, in the Journal of the American College of
Cardiology.
E
29
LabMedica International
April/2012
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PCR. The study was published in the
February 2012 issue of the Journal of
Clinical Virology.
Image: The MagNA Pure LC workstation (Photo courtesy of Roche).
PRODUCT NEWS
CHEMILUMINESCENCE
ANALYZER
DiaSorin
The Liaison XL is designed to provide
50%-90% higher throughput than the
existing Liaison analyzer. The system
features secure traceability of all
processes, from the status of
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information used to monitor work.
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www.LinkXpress.com or fill out reader service form located on last page
A1C SYSTEM
ELISA READER
EKF Diagnostics
Erba Mannheim
Euroimmun
The Quo-Test analyzer features
enhanced accuracy, bias, and
repeatability for samples from diabetic patients in the critical clinical
area. Key benefits include userfriendliness, consistent performance, reliability, and flexibility.
The LisaScan EM is designed as an
automated microplate reader that
can perform various tests with
reports and printing of graphs.
Features include single, dual, and
multiwavelength reading options, a
built-in shaker with 3-variable mixing, and self-diagnostic capabilities.
Two ELISA systems are intended to
provide separate detection of antibodies in Bordetella pertussis infections. One ELISA detects antibodies
against PT and the other detects
antibodies against FHA, with both
offering ease of use, accuracy, and
reliability.
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ELISA SYSTEMS
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Oncology Biomarker Database Includes
Cancer Companion Diagnostic Pathway
comprehensive cancer biomarker database has been launched
that can help in finding new diagnostic, prognostic, and companion diagnostic biomarkers.
The database includes cancer
A
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companion-diagnostics biomarker
pathway maps. It contains more
than 8,500 discovery phase, preclinical, or clinical cancer biomarkers
that were identified or validated
using patient derived samples.
LMI-04-12 130
Sciclips (Madison,
MI, USA; www.sciclips.
com) launched the database, which covers a
wide variety of biomarkers such as blood cancer
biomarkers (peripheral
blood, plasma, serum
etc), tumor biomarkers,
urinary cancer biomarkers, fecal cancer biomarkers, saliva cancer
biomarkers, breath cancer biomarkers, etc.
More than 100 types
of cancer are included in the cancer
biomarker database. For each cancer
type, the biomarkers are classified
into diagnostic biomarkers; for the
diagnostics application, disease predictive/risk assessment biomarkers;
for predicting the risk or genetic susceptibility in developing cancer; drug
efficacy/response biomarkers; biomarkers for studying the efficacy of
anticancer drug treatments, including predictive biomarkers and prognostic biomarkers; and for determining the clinical outcome in cancer
patients.
The types of cancer biomarkers
include protein biomarkers, miRNA
biomarkers, single-nucleotide polymorphism (SNP) biomarkers, gene
expression biomarkers, epigenetic
biomarkers, and metabolomic biomarkers.
With the growing trend of personalized healthcare concept and
advance in biomarker research,
there is a need for development of
innovative personalized cancer
drugs with companion biomarker
assays to identify the most appropriate cancer patient, tumor type, and
disease state.
Patient/sample details, experimental results, observations, biological and molecular functional analysis, biological process analysis, protein-protein interaction networks of
each biomarker are listed in the database. The pathway maps will help to
identify new anticancer drug predictive and response biomarkers for the
discovery of new drug targets with
improved efficacy or targeted therapy to overcome side effects, patient
stratification, developing personalized strategies for monitoring cancer
progression, treatment, diagnosis,
and prognosis.
Image: Companion diagnostics pathway analysis of biomarkers associated
with doxorubicin cardiotoxicity in childhood acute lymphoblastic leukemia
(Photo courtesy of Sciclips).
LabMedica International
April/2012
30
LabMedica
for daily laboratory medicine news click to www.labmedica.com
Lectin-Based Test Estimates
Glycated Hemoglobin
novel method has been developed for estimating the glycated hemoglobin (HbA1c) in
normal and diabetic patients using a glucose specific lectin.
The quantitative precipitin method was performed for the interaction between the glucosespecific lectin Concanavalin A (Con A) and the
glucose-containing RBC-lysate for the estimation
of calculated HbA1c% from a standard curve.
Scientists at the Cancer Centre Welfare
Home and Research Institute, (Kolkata, West
Bengal, India; www.cancercentrecalcutta.org)
selected 16 patients of both sexes with type-2
diabetes, age range 35–60 years, and four
patients with newly diagnosed type-1 diabetes,
age range 15–41 years. Twenty sex-matched
normal healthy subjects, age range 33-65 years,
were also included as controls. A precipitation
test of red cell lysate and Con-A was performed
and the precipitate estimated spectrophotometrically at 480 nm. For reference, plasma glucose
was estimated from the diabetic and nondiabetic subjects by glucose oxidase method using
A
phenol 4-aminophenazone and HbA1c% were
measured by ion-exchange high performance
liquid chromatography (HPLC) method with the
Bio-Rad D-10 analyzer (BioRad; Hercules, CA,
USA; www.bio-rad.com).
The absorbance range of the precipitate was
0.14–0.20 in normal subjects and the corresponding calculated HbA1c% along with plasma glucose levels was 4.1%-5.8% and 82-101 mg/dL,
respectively. For the diabetic patients, HbA1c
results were between 6.3%-12.2%, and the plasma glucose range was 120-292 mg/dL. Similar
results were observed for HbA1c% (6.1%-11.9%)
of the same diabetic samples measured by conventional ion-exchange HPLC. The nondiabetic and
diabetic hemoglobin variant subjects consisted of
HbE-β-thalassemia, β-thalassemia carrier state,
HbE trait, and HbS trait, showed similar HbA1c%
by the lectin-based assay when compared with
standard HPLC method.
The authors concluded that the lectin-based
assay may be adopted to estimate glycated hemoglobin level in differentiating between normal and
diabetic patients. This
assay offers a good correlation with standard
HPLC method, and
moreover, the method
globulin E (sIgE) testing is widely
available to physicians, but the report
sets out several caveats that physicians need to keep in mind when
using these tests and before embarking on immunotherapy.
Both serum sIgE tests and skinprick tests have similar diagnostic
properties with specific pros and cons.
Skin-prick tests offer immediate results
and are low cost, but they require the
availability of rash-free skin.
Serologic tests are not affected by
antihistamines or extensive dermatitis, but require a blood sample and
cost more.
The report also includes guidance
on specific allergies: e.g., for asthma
the physician is advised to follow
national guidelines and test for
indoor allergens (dust mites, mold).
There is no current evidence that
testing for total IgE will identify specific food allergies. In addition IgE
tests are not relevant for many drug
reactions. The diagnostic value of
serum tests is not well characterized
for latex allergies. A localized reaction at an insect bite or sting site does
not indicate a risk for anaphylaxis;
testing is not warranted.
In vitro allergen-specific immunoglobulin E (sIgE) testing is widely
available to physicians, but the report
sets out several caveats that physicians need to keep in mind when
using these tests and before embarking on immunotherapy.
Immunoglobulin E Tests Not
Always Reliable for Infants
hysicians are warned not to rely
on allergen-specific immunoglobulin E (IgE) tests for pediatric allergies.
The mere detection of sensitization to an allergen on IgE tests is not
always equivalent to a clinical diagnosis, cautioned a clinical report from
the American Academy of Pediatrics
(AAP; www.aap.org).
The advisory from two allergists,
Robert Wood of the Johns Hopkins
Children’s Center (Baltimore, MD,
USA; www.hopkinschildrens.org) and
Scott Sicherer of Mt. Sinai Hospital (New York, NY, USA; www.
mountsinai.org), urges clinicians to
use caution when ordering allergy
tests and to avoid making a diagnosis
based solely on test results.
Most allergies result in the production of IgE antibodies that are specific to that allergen. A report, published in the January 2012 issue of
Pediatrics, offers aid to pediatricians
in selecting the appropriate allergy
tests, and interpreting the results in
the context of a patient history and
clinical presentation.
The detailed medical history and
tests must be interpreted in the presence of a clinical presentation, the
authors noted. For instance, a child
who eats eggs without any symptoms
does not need to undergo testing for
an egg allergy. The same holds true
for pollen testing when a child is not
physically exposed to a certain pollen.
In vitro allergen-specific immuno-
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31
LabMedica International
April/2012
is convenient, cheap, and needs no sophisticated
instruments, and therefore suitable for laboratories in poor resource settings. The study was published online on January 24, 2012, in the Journal
of Clinical Laboratory Analysis.
Image: The D-10 hemoglobin testing system (Photo
courtesy of Bio-Rad).
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TECHNICAL
LITERATURE
F R E E S E RV I C E • S E RV I C E G R AT U I T • K U N D E N D I E N S T G R AT I S • S E RV I C I O G R AT U I TO • S E RV I Z I O G R AT U I TO
BORRELIA KITS
Aesku Diagnostics
Two Elisa kits are
available for the detection of Borrelia-specific
IgG and IgM antibodies. Both kits are fast,
easy to handle, and
adapted to routine use.
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CATALOG
2011-2012
PRODUCT
CATALOG
IMMUNOASSAY
LAB CENTRIFUGE
DiaSorin
MPW Med.
Instruments
SUPPORT
SOFTWARE
Astra Biotech
Axiom Diagnostics
Products available include reagents and
semi-products, Elisa
test kits, tumor markers, molecular genetic
test kits, and microarrays.
Products available include clinical chemistry
instruments, rapid tests,
Elisa readers and instruments, pipettes, centrifuges, microscopes,
and more.
The Liaison XL murex
HIV Ab/Ag is designed for the combined
screening of HIV Ag
and HIV Ab. The test
offers high specificity,
and is flexible and
easy to use.
The MPW 380R features a graphic LCD
display, 99 operating
programs, SHORT operation mode, automatic lid opening, and
modern software.
The STA Coag Connexion is designed for
managing and supervising Stago systems.
The software allows
for management of patient results, as well as
QC.
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Diagnostica Stago
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High Throughput System
Automates Human
Papillomavirus HR Test
high throughput system automates the
DNA extraction and detection steps of the
Human Papillomavirus high risk (HPV HR) test
allowing users to walk away after loading the
instrument and return the next morning to
review the test results.
The Hologic (Bedford, MA, USA; www.
hologic.com) HPV HR test utilizes the Invader
technology to detect 14 high-risk types of HPV
that are associated with cervical cancer and precancerous lesions.
The US Food and Drug Administration (FDA;
Silver Spring, MD, USA; www.fda.gov) have
approved the Cervista high throughput automation system for cervical cancer screening.
Better diagnosis and therapies have helped to
reduce significantly the number of new cancer
A
cases, advanced-stage tumors, and
ultimately deaths from cervical
cancer in particular, which is predominantly caused by HPV. Next
to breast cancer, cervical cancer
remains the second most frequent
cancer affecting women worldwide.
“Our new Cervista represents a
significant addition to our molecular diagnostics product portfolio,”
said Rob Cascella, president and
CEO of Hologic. “The Cervista
HTA automation system automates the HPV HR
test, providing higher throughput, improved
chain of custody, and accurate results. We are
extremely pleased to get this product approved
as it materially changes the competitive landscape for Hologic.”
Image: The Cervista testing kit, designed for cervical cancer screening (Photo courtesy of Hologic).
Biomarker Detects Cardiac Event Immediately
biomarker has been used to identify patients
that have experienced a heart attack, enabling
physicians to undertake aggressive treatment
immediately.
The diagnostic performance of newly developed
highly sensitive troponin I (hsTnI) assay was compared with a contemporary troponin I (cTnI) assay
and their serial changes in the diagnosis of heart
attack.
Scientists at the University Heart Center
(Hamburg, Germany; www.uke.de) studied a
cohort of 1,818 patients with suspected acute coronary syndrome, conditions such as heart attack or
angina. The patients were enrolled in the study at
chest pain units in Germany from 2007 to 2008.
Twelve biomarkers including hsTnI and cTnI were
measured on admission and six hours later. Heart
attacks are clear in the public perception, and hospital admission for chest pains are one of the most
common complaints. Highly sensitive troponin
A
assays have been developed recently, and these
tests can reliably assess troponin levels in more
than 50% of the general population.
For the cTnI assay, the Architect STAT troponin I
assay was used. The level of detection was 10
pg/mL, with a range of 0-50,000 pg/mL. The 99th
percentile and the concentration with coefficient of
variation of 10% is 32 pg/mL. The diagnostic threshold for myocardial infarction (MI) according to the
World Health Organization’s (Geneva, Switzerland;
www.who.int) definition was given as 300 pg/mL
by the manufacturer (Abbott Diagnostics, Abbott
Park, IL, USA; www.abbott.com). The same manufacturer’s prototype cardiac troponin I assay
(Architect STAT High Sensitive Troponin) was used
for hsTnI assay. For this assay, the level of detection
is 3.4 pg/mL with a range, 0-50,000 pg/mL and the
coefficient of variation is 10% at a concentration of
5.2 pg/mL.
For discrimination of acute MI, both hsTnI and
cTnI were superior to the other evaluated diagnostic biomarkers. Using the 99th percentile cutoff,
hsTnI on admission had a sensitivity of 82.3% and
negative predictive value (NPV) of 94.7%; hsTnI
determined after three hours had a sensitivity of
98.2% with NPV of 99.4%. Compared with hsTnI,
the cTnI assay, using the 99th percentile as cutoff
had comparable sensitivity and NPV: 79.4% sensitivity and 94.0% NPV on admission, and 98.2%
sensitivity and 99.4% NPV after three hours.
Till Keller, MD, a senior author of the study, concluded that “The shortcoming of conventional troponin assays with low sensitivity within the first
hours after chest pain onset led to the evaluation of
various so-called early biomarkers in the diagnosis
of MI. In our study, the diagnostic information of
hsTnI was superior to all other evaluated biomarkers alone.” The study was published on December
28, 2011, in the Journal of the American Medical
Association (JAMA).
LabMedica International
April/2012
32
Edited by Edgard Delvin, Ph.D., FCACB
IFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry,
CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5
Tel: (1) 514-345-4831 (ext. 5635); E-mail: [email protected]
NEWS
Slovak Conference Focuses on
Quality Control in Lab Diagnostics
Contributed by Marko Kapalla, Slovakian EPMA Representative
and Program Committee Chairman
n November 2011, the beautiful city of Poprad, “Capital” of the Slovak High Tatras
Mountains greeted the biennial international conference Labkvalita 2011, on quality in
clinical laboratory diagnostics of the Slovak Society of Clinical Biochemistry
(www.sskb.sk). Since 1993, this conference, accredited to give continuing medical
education credits, attracts Slovak and foreign laboratory professionals, practitioners
and specialists.
This year the program focused on new trends in predictive, preventive, and personalized medicine (PPPM) not only from the technology and quality points of view but
also from those of ethics, law, finance, and politics. Approximately 180 delegates registered, and 19 suppliers and manufacturers provided exhibits to promote new products in the field of clinical laboratory
diagnostics.
The Scientific program was divided
into 5 sections: Preanalytics; Predictive,
Preventive, and Personalized Medicine;
Cooperation between the laboratory and
the clinicians; Accreditation and quality
in medical laboratory; and Quality of
healthcare policy, visions, and ethics.
Lecturers from Austria, Belgium, Czech
Republic, Finland, Germany, United
Kingdom, and Slovakia gave the various
talks on particular topics. Details of the
program are available at www.sskb.sk.
Among invited lecturers, there were
also top representatives of European
Association for Predictive, Preventive,
and Personalized Medicine (EPMA) who
kindly accepted the invitation and were
delighted by warm welcome and the
interest of SSKB in promoting PPPM
among clinical laboratory professionals
in Slovakia. Implementation of PPPM at
different levels has been repeatedly presented as an attribute of increased quality in healthcare.
I
Highlighted Themes and Debates
The lectures given and the subsequent
discussions have emphasized the role of
new predictive markers, role of information systems, importance of good cooperation between laboratory and clinicians, essential role of education, interactive communication with health insurance, greater participation of Slovak laboratory professionals on shaping the
healthcare policy for the benefit of the
patient, and the role of communication
with the patient. Among the highlighted
themes were also the following:
• PPPM will have impact on laboratory
diagnostics and it may substantially
improve the quality and complexity of
the services in the field of laboratory
diagnostics if implemented into daily
routine of clinical laboratories.
• Accreditation of the clinical laboratories in Slovakia continues and more
laboratories realize that the benefits
of accreditation outweigh the troubles, paperwork, and the required
energy dedicated to keeping the
accreditation once the lab is accredited. On the other hand, accreditation
Cont’d on page 34
33
LabMedica International
April/2012
Photo: (From left to right) Katarina Danova, president of the Slovak Society
of Clinical Biochemistry, Jan Balla, IFCC representative in Slovakia and program committee member, Marko Kapalla, EPMA representative in Slovakia
and program committee chairman. Photo by Magdalena Kacaniova
News from the World of the International
Federation of Clinical Chemistry and Laboratory Medicine
Visit www.ifcc.org for more information
NEWS
My IFCC Professional Scientific
Exchange Program (PSEP) Experience
deoxyribonucleic acid (DNA).
Observation and hands-on
experience in the various
phases of this process have
greatly improved my confidence in the use of these
techniques. These analyses
require top quality controls
and laboratory safety, to
which the staff strictly
adheres. The environment
and friendly atmosphere are
conducive to the success of
the laboratory. I am now
applying what I have learned
to the molecular diagnosis of
azoospermia. I designed the
required primers and I am Photo: (From left to right) Prof. Maurizio Ferrari,
presently setting the condi- Dr. Mabel Charles-Davies
tions for multiplex PCR.
Chemistry of Nigeria (ACCN).
On the social side, hospitality and
I am very grateful to the IFCC for
courtesy are part of the ltalian culture.
granting me the PSEP. It was finanI found everyone friendly and ready to
cially very stressful before this aid,
help, even not convenient. My enrolbecause of the relative cost of transment in an Italian school for foreigners
portation and accommodation bet2 hours a week greatly enhanced my
ween Nigeria and the EU.
interaction with others, particularly
I must extent my wholehearted
outside the laboratory where English
thanks to Prof. Maurizio Ferrari, who
language, my mode of communicagenerously opened his doors, and
tion, is scarcely understood.
offered his staff and facilities in the
This Professional Scientific Exdevelopment of my career. I am particchange Program was the beginning
ularly grateful to Dr. Paola Carrera (in
of a true collaboration between my
charge of my training) and Dr. Mascia
institution, the University of Ibadan
Di Marzio (who supervised my hands(Nigeria), and the Vita-Salute San
on experience in 21β-hydroxylase
Raffaele University, in Milan (Italy).
enzyme work, including interpretation),
I recommend the continuation of
and the whole laboratory staff of the
the IFCC PSEP program in settings
Department of Molecular Biology and
with advanced technologies, in particCytogenetics for their assistance and
ular for individuals from developing
friendliness. I am also grateful to Ms.
countries. This will, beyond courses
Denise Bottoni (Prof. Ferrari's
organized by the IFCC both within and
Secretary) and Dr. Monica Zanusi for
outside their countries, build capacity
their availability that made my stay
and increase confidence in the use of
socially comforting. I cannot thank
advanced technologies in their laborathem enough. I also wish to thank Prof.
tories. The additional knowledge and
E.O Agbedan, my Department Head at
experience I have gained in Milan will
the College of Medicine, University of
impact on my colleagues and stuIbadan, for his support and advice.
dents, and the Association of Clinical
by Dr. Mabel A. Charles-Davies, Immediate Past IFCC National
Representative (Nigeria), Department of Chemical Pathology,
College of Medicine, University of Ibadan, Ibadan, Nigeria.
he purpose of spending my sabbatical period in Prof. Maurizio
Ferrari's laboratory was to improve
my capacity of applying advanced
technologies, particularly molecular
biology, in the of diagnosis of diseases, and in research in the field of
reproductive endocrinology. My
exposure to the “state of the art”
molecular biology techniques in Prof.
Ferrari's Laboratory has allowed me
to fulfill my dreams and aspiration.
My attendance at the International
Federation of Clinical Chemistry and
T
Laboratory Medicine (IFCC) course
in Molecular Biology in Milan (Italy) in
2006 was intended to achieve the
above objective but time was short,
and facilities were then unavailable in
our laboratory to continue with what
was learnt.
In the last few months, I have been
through various aspects of molecular
diagnosis of 21β-hydroxylase enzyme
deficiencies. Southern blotting and
hybridization as well as polymerase
chain reaction (PCR) and sequencing
were applied after having extracted
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Slovak Conference Focuses on Quality Control
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LMI-04-12 134
itself cannot guarantee the quality
under insufficient quality of healthcare policy where there are numerous distortions in the field of laboratory diagnostics.
Distortion of professional attitude is
repeatedly noticed in the case were
competing laboratories, being under
pressure from investors, try to gather
as many samples as possible, often
forgetting that the service they offer
is done for the patient and not for the
sheer profit of the investor.
Distortion of laboratory services and
decreasing quality is also caused by
the attitude of the health insurance
companies, which often “reimburse”
money according to very questionable policy that frequently ruins any
possible and essential progress in
clinical laboratory diagnostics. This
distortion of the common sense
comes from the utterly underestimated role of the laboratory diagnostics
in healthcare by the government and
politicians.
• Distortion of fair competition in laboratory diagnostics resulting from the
potential conflicts of interests is
another problem of clinical laboratory
diagnostics in Slovakia, which delegates of the conference perceive as
an unacceptable situation.
Although clinical laboratory diagnostics
is essential field for medicine, and is recognized by EPMA in the concept of predictive, preventive and personalized medicine, with help and political backing from
other experts and international organizations, clinical laboratory professionals
must exert substantially more effort to
change the unsustainable situation in
Slovak clinical laboratory diagnostics in
order to increase the quality to the level
that can be appreciated by the patient.
LabMedica International
April/2012
34
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NEWS
News from the World of the International
Federation of Clinical Chemistry and Laboratory Medicine
Visit www.ifcc.org for more information
IFCC Task Force for Young Scientists
Holds Educational Workshop in India
Contributed by Pradeep Kumar Dabla, IFCC-TF YS Member & National Representative
s part of the efforts of IFCC-Task Force Young
Scientists (IFCC-TF YS) to promote networking between young scientists, to involve them in
activities of laboratory medicine, and to promote
the future of laboratory medicine, the IFCC-TF YS
in collaboration with the Association of Clinical
Biochemists of India (ACBI) held an Educational
Workshop on December 3, 2011. The program
was well attended by more than 100 candidates
from various streams all over India. The event was
hosted by the ACBI Conference (ACBICON) 2011
Organizing Committee under supervision of Dr.
Neelima Singh (Organizing Secretary), and held
at the ITM University, Gwalior (Madhya Pradesh,
India).
IFCC has identified the need for young scientists to participate in Task Force activities and to
understand the latest practices in laboratory healthcare sector. Therefore, various Educational workshops have been organized during IFCC and
Member Societies Congresses under the roof of
IFCC-TF YS. The concept of these activities is to
encourage interactions between young scientists to
face challenges, and to brighten the future
prospects of self and laboratory medicine.
A
In keeping with these objectives, the Task Force
organized Educational Workshop themed “Think
The Unthinkable.” For the first time, this workshop,
second in continuation of the one-day workshop
organized during the 37th Conference of the
Association of Clinical Biochemists of India in
December 2010, brought the laboratory medicine
and Industry together, stressing on Various Job
Opportunities present in Industry and other sectors
related to Laboratory Medicine. This was an important step since it sought to share experiences,
scope, and a common platform for both the laboratory personnel and the industry, which will lead to
well-thought solutions to bridge the gap.
The workshop was organized with close cooperation with IFCC and ACBI. Addressing the conclave, Mr. J. Lopez (EB-IFCC & Past-President
APFCB) praised the Task Force initiative and
stressed upon the need to share experiences and
challenges around the world. He explained the
need of live sessions to demonstrate the laboratory
management to build the future leadership. Then,
Dr. Sucheta Dandekar (President ACBI) addressed
and summarized the ACBI initiatives for the young
biochemists. Dr. Pradeep Kumar Dabla, convener,
Photo: (Left) Dr. Pradeep Kumar Dabla, Head of
the Department of Biochemistry, Chacha Nehru Bal
Chikitsalya Pediatric Superspecialty Hospital, New
Delhi receiving a memento from Mr. Joseph Lopez,
IFCC Executive Board Member, representing the
President Dr. Graham Beastall.
and National Representative IFCC-TF YS discussed the Task Force objectives and commitment
of focused trainings to strengthen the future
prospects of young laboratorians in absence of
Damien Gruson, Chair IFCC-TF YS. The all senior
members and EB-ACBI were present to support the
cause.
Dr. Dabla stressed, “With a robust general economy and with extraordinary advances being made
in biotechnology and biopharmaceuticals, excellent
positions are available in a wide variety of fields for
current and future college graduates.” While discussing various fields he emphasized on making a
decision about what type of career and exactly
what field will be best for you and the importance of
dual proficiency of management training. Dr.
Elizabeth Frank (Chair of the Clinical Lab
Management Committee of the IFCC & elected
Secretary APFCB) explained the work strategies
related to jobs vs. careers. Then she discussed
about Entrepreneurship and how to start and managing your own business. Dr. Gurumukh Advani
(Sales President Transasia) gave the view on how
India is emerging as leading player in business and
economy. He pointed out, “Healthcare delivery is
growing as a largest service sector with excellent
15% growth per annum in India,” and explained the
role of biochemists in lab industry. In this blend of
excellent professionals, Mr. Shankar Haveri, (Head
Healthcare
Learning
Academy,
Siemens
Healthcare) discussed the learning academy programs and opportunities in various less known
areas of IVD Industry. In row, Dr. Rajesh Bendre
(Consultant Pathologist & HOD Immunochemistry,
Metropolis Healthcare) explained the concept of
Clinical Reference laboratories, the role of laboratory professionals and the job profiles and career
opportunities. He emphasized on the need of multitasking behaviour and flexibility. Dr. Dabla, ended
by giving Dr. Gruson's view about the young scientists and laboratory medicine.
To summarize, the workshop has provided tangible results for the young laboratory professionals
to select the right path after completing their studies. It has provided the vision about the various
techniques and essentials to reach the right destination.
LabMedica International
April/2012
36
News from the World of the International
Federation of Clinical Chemistry and Laboratory Medicine
Visit www.ifcc.org for more information
NEWS
AACB News: Looking
Back to Look Ahead
Contributed by Sandra Klingberg, Chair AACB Media and
Communications Committee; Editor, Clinical Biochemist Newsletter
he year 2011 has been a year of
milestones for The Australasian
Association of Clinical Biochemists
(AACB), the most notable of these
being the celebration of 50 years
since the formation of the AACB in
May 1961.
Our Golden Jubilee was celebrated throughout the year with special
events held in each of the Branches
including the Roman Lecture tour
featuring one of our founding fathers,
Prof. Geoffrey Kellerman. The
Golden Jubilee was also the key
focus of our annual scientific meeting
in October celebrating “Laboratory
Medicine - Past, Present & Future.”
Other significant milestones for
the AACB include the induction of a
new President Dr. Andrew St John
and a new Chief Executive Officer
(CEO), Mr. Peter Graham.
Prof. Leslie Burnett vacated the
office of president at the annual general meeting of the Association in
October with Dr. Andrew St John taking the helm. In articles recently pub-
T
lished in the Clinical Biochemists
Newsletter, both Prof. Burnett and Dr.
St John reflected on things past,
present, and future.
Key issues and highlights noted in
these two reports included:
• Development of international collaborations and cooperation with
sister Associations such as the
APFCB, IFCC, AACC, and ACB
• Forging new links with the EFCC
and emerging Associations in
South-East Asia
• Progression of workforce issues
through the reactivation of
Pathology Associations Council
• Initiation and participation in a
number of major new scientific initiatives, including the introduction
of reporting of the eGFR, international standardization and dual
reporting of HbA1c, standardization of pathology and terminology,
and most recently, pathology harmonization
• Relocation of the AACB Head
Office from Perth to Sydney with
Photo: Celebrating the AACB's 50th Birthday: Prof Geoffrey Kellerman (2nd
from the left), 2011 AACB Roman Lecturer, with the Victorian AACB Branch
Committee.
co-location and strategic alliance
with the Human Genetics Society
of Australia (HGSA) to better position the AACB for the genomic
revolution
The relocation of the Office has
also brought about another of the significant changes to the “face” of the
AACB in 2011 with the recent retirement of our CEO, Mr. Tony Prior. The
AACB is indebted to Tony's dedicated
service over the last ten years, which
was recognized with the presentation
of an outstanding service medallion
at the annual scientific meeting. The
good news is that we have a new
CEO in Mr. Peter Graham who brings
a wealth of laboratory and management experience with him. The AACB
looks forward to long and productive
working relationship with Peter as we
move forward into our next 50 years!
IFCC Welcomes New Corporate Members
Mindray
www.mindray.com
Mindray, founded in 1991 with the goal
of delivering high quality, competitively
priced medical devices to make
healthcare more accessible and
affordable around the world was listed
on the New York Stock Exchange in
2006. The company has three wellestablished business segments:
Patient Monitoring and Life Support
Products, In Vitro Diagnostic Products,
and Medical Imaging Systems. Health
care facilities equipped with Mindray's
products can be found in over 190
countries and regions. IVD Mindray
has a global R&D network with
research centers in Shenzhen (China),
Beijing (China), Nanjing (China),
Seattle (USA), New Jersey (USA), and
Stockholm (Sweden).
Merck Millipore - Millipore SAS
www.millipore.com/labwater
Merck Millipore is the Life Science
division of Merck KGaA of Germany
and offers a broad range of innovative, performance products, services,
and business relationships that
IFCC OFFICE
Via Carlo Farini 81, 20159 Milan, ITALY
Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846
E-mail: [email protected] • Web: www.ifcc.org
Office Hours: 9.00-13.00 and 14.00-18.00
Staff Members: Paola Bramati, Silvia Cattaneo,
Silvia Colli-Lanzi
37
LabMedica International
April/2012
enable our customers' success in
research, development, and production of biotech and pharmaceutical
drug therapies. Through dedicated
collaboration on new scientific and
engineering insights, and as one of
the top three R&D investors in the Life
Science Tools industry, Merck
Millipore serves as a strategic partner
to customers and helps advance the
promise of life science.
Nova Biomedical
www.novabiomedical.com
Nova Biomedical's clinical laboratory
business comprises point of care IVD
test systems used in hospital and primary care settings. These include innovative new hand-held point of care sensors as well as an array of blood gas
and critical care analyzers offering a
wide menu range.
Immunodiagnostic Systems (IDS)
www.idsplc.com
Immunodiagnostic Systems (IDS) is
dedicated to the development and provision of innovative Immunoassays
and automated immunoanalyzer technologies for use in clinical and research laboratories worldwide. The
company enjoys a dominant position in
the provision of immunoassay kits for
the determination of Vitamin D (both
25-Hydroxy Vitamin D, and 1,25Dihydroxy Vitamin D.
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LMI-04-12 137
EFLM CORNER
European Federation of Clinical
Chemistry and Laboratory Medicine
Edited by Dr. Bernard Gouget
European Funding:
A Financial Windfall to Seize
for Innovative Projects
by Dr. Bernard Gouget
SFBC-EFLM Representative; IFCC Treasure;
Secretary General, International Francophone Federation
of Clinical Biology and Laboratory Medicine (FIFBCML)
ublic health, research, and continuing education
are fields in which the European Commission
awards financial aid. This community funding exists
to implement projects or activities related to
European Union policy. This funding can be awarded to companies, associations, and healthcare facilities, in the form of subsidies or investment grants.
European policies are divided into thematic programs such as the 2007-2013 health program (the
one for 2014-2019 is being negotiated) or the
Program of the European Community for research,
technological development, and demonstration
activities. Next, these programs are subdivided into
projects and then funding means. Brussels regularly issues calls for projects, open to all interested
candidates. To respond, candidates must submit
proposals with a European dimension and involving,
in principle, at least three Member States. Beyond
this requirement, the conditions to fulfill for participation vary. The list of calls for proposals is available
on the Commission Website (http://ec.europa.eu/
index_en.htm under the section “Public Contracts
and Funding,” subsection "Grants").
An innovative e-learning experience was led by
Prof. Corberand, hematology, at the Rangueil
Toulouse University Hospital, which coordinated the
e-HEMATimage interactive multilingual project as
part of the Leonardo da Vinci Program in the field of
education and continuing training. The goal was to
create online continuing-education programs on the
topic of hematology. The programs are available in
eight languages and accessible to medical biology
professionals. In 2009, this successful operation
generated a second, e-MEDICINimage (www.
e-hematimage.eu/index.jsp?Langue=en&Pays=GB),
with the goal of improving knowledge and knowhow, in the fields of hematology, mycology, and parasitology for all medical biology laboratory profes-
P
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LMI-04-12 140
sionals (doctors, scientists and technicians) concerned with performing and interpreting hematological, mycological, and parasitological exams. The
site offers real cases taken from laboratory experience, with access in the user’s native language,
records validated by scientific societies, supervision
by recognized specialists, and from of personal projects.
The European Commission also funded
research on the genome, cancer, and even
Alzheimer's disease. If they are not the leader of a
European project, health facilities and laboratories
or services can work with a private company, a medical research unit, such as INSERM in France, or a
research center that received an EU grant. Between
2003 and 2009, for example, the European
Commission supported 50% of the cost of the
MyHeart project for developing intelligent systems
for preventing and detecting cardiovascular disease.
This equaled sixteen million euros. Among the forty
partners and beneficiaries of the project are the San
Carlos Hospital of Madrid (Spain), and the Coimbra
(Portugal) and Aix-la-Chapelle (Germany) University
Hospitals. The Commission never funds a project in
its entirety; however, the sums paid can be substantial. Most often, the allocated budgets are managed
by a public authority, with its partners to be clearly
identified before its project is designed. Setting up
projects is difficult, but European associations such
as the European Hospital and Healthcare
Federation (HOPE) can provide valuable and effective assistance.
The e-MEDICINimage project is a good example
of the generalization of e-learning in our education
and training systems. Connectivity and equipment
are no longer central questions, and the focus is
now on problems of pedagogy, content, and quality
assurance and standards, training of teachers and
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trainers, and of continuous development, organizational change and transformation processes of education and training. E-learning has entered adulthood and we are in the process of evolving from
preparation to practice and from pilot e-learning
projects to lasting education and training programs.
The European Federation has demonstrated its
clear understanding by establishing a WG on distance learning. Moreover, its newly named
“European Federation of Clinical Chemistry and
Laboratory Medicine” will undoubtedly factor in creativity in e-learning on many subjects!
New Acronym for EFCC
he Executive Board of the European Federation
of Clinical Chemistry and Laboratory Medicine
has become aware that the abbreviation EFCC is
often misidentified as IFCC by other international
organizations, National Societies and other stakeholders as well as by individuals from the profession.
In the past, this has caused confusion and sometimes has undermined the identity of the Federation.
After consultation with National Representatives
and Presidents of our Member Societies, he
Executive Board has agreed to adopt EFLM to
replace EFCC as the acronym to describe our
Federation. The full name of the Federation remains
unchanged: European Federation of Clinical
Chemistry and Laboratory Medicine.
We take this occasion to thank all our National
Society Members for supporting the Executive Board
in this important decision for the future “branding” of
our Federation
Yours sincerely, Ian Watson, EFLM President
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LMI-04-12 139
LabMedica International
April/2012
38
European Federation of Clinical
Chemistry and Laboratory Medicine
EFLM CORNER
14th Berkes Annual
Scientific Conference
Held in Belgrade
by Dr. Snezana Jovicic,
Member of the IFCC eNews Working Group
he 2011 Annual Scientific Conference “Professor Ivan Berkes”
was held on December 1, at Military
Medical Academy in Belgrade
(Serbia). As it is customary, the lecturers were clinical laboratory professionals who have defended their doctoral thesis in the course of the past
year at the Faculty of Pharmacy and
Faculty of Medicine. This year, they
were Dr. Janko Pejovic (Military
Medical Academy, Belgrade), Dr.
Marijana Dajak (Faculty of Pharmacy, University of Belgrade), Dr.
Jasenka Lalos-Miljus (Faculty of
Medicine, University of Banja Luka,
Republic of Srpska, Bosnia and
Herzegovina) and Dr. Jelena Popovic
(Faculty of Medicine, University of Nis,
Serbia).
This Annual Scientific Conference
and Fund “Professor Ivan Berkes“
was established to honor life and work
of Prof. Ivan Berkes, one of the
founders of medical biochemistry in
former Yugoslavia. He taught medical
biochemistry at Universities in Zagreb,
T
Skopje, and Belgrade. His work at the
Faculty of Pharmacy of the University
of Belgrade was in great part directed
towards the definition and foundation
of the specialist studies program. In
addition, Prof. Berkes introduced
Clinical Enzymology as an independent discipline. With over 200 publications, mentoring of 150 specialists in
medical biochemistry and several
tens of doctoral candidates, Prof.
Berkes left an indelible mark in clinical laboratory profession in Serbia.
After his death in 1997, the Society of
Medical Biochemists of Yugoslavia
and the Faculty of Pharmacy of the
University of Belgrade founded the
Scientific Fund and Annual Scientific
Conference named after him, as a
sign of appreciation and respect for
this remarkable teacher and eminent
expert.
Awards from the Scientific Fund
“Professor Ivan Berkes” are given
yearly to the two best graduate students from the Faculty of Pharmacy of
the University of Belgrade, one gradu-
2nd EFCC-UEMS European
Joint Congress: Laboratory Medicine
at the Clinical Interface
e take this opportunity to inform
you that the Scientific Program of
the 2nd EFCC-UEMS European Joint
Congress has been finalized and is now
available at www.dubrovnik2012.com.
The Scientific Committee has done a
great job in gathering the recognized
international experts in the field who will
be presenting the latest news and findings in their field. The Scientific Program
will encompass 3 plenary sessions, 15
scientific symposia, 4 highly interactive
pro- and contra- sessions, as well as a
series of specialized industry sponsored
workshops.
We would like to draw your particular attention to the S10 Session
(Friday, October 12, 2012, 14:0015:30) on Education of Specialists in
Laboratory Medicine in Europe within
which most recent advances in the
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39
LabMedica International
April/2012
Photo: (From left to right) Awarded students with the Dean and Professors of
Faculty of Pharmacy; Milena Andelkovic, Prof. Nada Majkic-Singh, Prof. Nada
Kovacevic, Sanela Dordevic, Ana Milojevic, Prof. Svetlana Ignjatovic
ate in pharmacy, and the other in medical biochemistry. However, 2011
called for a special event as the first
students graduated according to the
new syllabus harmonized with the
Bologna declaration. Hence, this year
the Fund gave four diplomas and
monetary awards; two to students
graduated according to previous
school system - Mladen Milovic (pharmacy
graduate)
and
Milena
Andelkovic (pharmacy-medical biochemistry graduate), and two to
“Bologna graduates” - Sanela Dordevic (Master of Pharmacy) and Ana
Milojevic (Master of Pharmacy-medical biochemistry).
After the traditional welcoming
address of Colonel Prof. Marijan
Novakovic, Head of Military Medical
Academy, and of Prof. Nada Kovacevic, Dean of Faculty of Pharmacy,
and Chair of the event, Prof. MajkicSingh, presented awards.
With this successful conference,
we remembered once again, the legacy of Prof. Ivan Berkes, whose students represent the core of science of
medical biochemistry and clinical laboratory practice in Serbia today.
recognition of the profession at the
European level will be presented and
discussed.
Abstract Submission is also now
available at the Congress web site. Best
posters will be awarded with Poster
awards.
Dates to remember:
• Abstract Submission Deadline:
May 15, 2012
• Early Registration Deadline:
May 1, 2012
We proudly announce that EFLM
(formerly EFCC) Travel grants are available for Young Congress participants.
For more details, please visit: www.efcclm.eu.
We look forward to see you in
Dubrovnik!
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LMI-04-12 138
EFLM CORNER
European Federation of Clinical
Chemistry and Laboratory Medicine
EFLM Reaches Collaboration Agreement with the
European Society for Pharmacogenomics and Theranostics (ESPT)
Memorandum of Understanding
has been prepared to define a collaborative working relationship between EFLM and ESPT, the European
Society for Pharmacogenomics and
Theranostics, to foster the cooperation
and to advance Clinical Laboratory
Medicine. The European Society of
Pharmacogenomics and Theranostics
(ESPT) is a nonprofit organization,
whose aims are to promote the education and research in pharmacogenomics and theranostics, to ensure the
high standards in their application to
clinical practice for improving the delivery of medicines, to provide a scientific
basis for official recommendations and
to provide education materials for
patients, clinicians and all health workers. For further information, the document is downloadable at the following
link: http://efcclm.eu/downloads/ (section: Agreement)
A
EFLM Presence at
National Society Meetings
The Executive Board appreciates the
support it receives from National
Societies and individual members of
these societies in the various past and
current EFLM activities. To foster this
relationship, EFLM officers' attendance, and their active participation
as invited speakers has been
arranged during the following National
Congresses:
• 11th Baltic Congress of Laboratory
Medicine - Vilnius (LT), May 10-12,
2012
• Congress of the Slovak Society of
Clinical Biochemistry (NC SSCB) Banska Bystrica (SK), May 27-29,
2012
• XXXIII Nordic Congress in Clinical
Chemistry - Reykjavik (IS), June
12-15, 2012
• National Days for Russian Laboratory Medicine - InterLabDiagnostika 2012 - Moscow (RU),
October 2-4, 2012
• 7th Conference of the Romanian
Association of Medical Laboratories (RAML) with International
Participation - Sinaia, Romania
(RO), June 20-23, 2012
New Type of Membership:
Young Membership
The EFLM Executive Board to
strengthen the role of Young
Scientists inside its Working Groups
invited National Societies to send
nominations. The number of Full
Members' positions inside each EFLM
Working Group has been enlarged to
enable Young Scientists to take part in
the WG activities.
A large number of nominations was
received and the selected candidates
are as follows:
Cardiac
Markers
(WG-CM):
Christopher DUFF (UK); Biological
Variation (WG-BV): Federica Braga
(IT); Guidelines (WG-G): Shivani
Misra (UK); Test Evaluation (WG-TE):
Philip Monoghan (UK); Preanalytical
Phase (WG-PA): Michael Cornes
(UK); Congresses and Postgraduate
Education (WG-CPE): Andjelo Beletic
(SRB); Distance Education and eLearning (WG-DE): Darya Kisilichina
(RU); Accreditation and ISO/CEN
(WG-A/ISO): Kanella Konstantinakou
(GR)
Working Group:
Preanalytical Phase (WG-PA)
The pre- and post-analytical phases of
the laboratory testing process are now
widely recognized as the major source
of laboratory errors. Preanalytical
errors are the most common and
account for up to 2/3 of the total number of errors. The risk for errors in the
laboratory testing process quite is
underestimated in the everyday clinical practice. To reduce the error risk,
important steps are to increase the
awareness of the importance of the
preanalytical phase in the total testing
process and recommend guidelines
for the best preanalytical practices.
Efficient indicators and educational
tools should be provided in order to
implement the best preanalytical practices.
For this reason, a new EFLM WG
was created under the Chairmanship
of Prof. Ana-Maria Simundic (Croatia).
This WG will focus their work on
the following:
1) To promote the importance of the
quality of the preanalytical phase
of laboratory medicine;
2) To define the best practices and
provide recommendations for
some critical activities in the preanalytical phase;
3) To design and validate questionnaires for assessing the current
practices related to some pre-analytical variables;
4) To conduct surveys using validated
questionnaires with the aim to
assess the current pre-analytical
practices;
5) Organize symposia, workshops,
webinars, or training courses on
preanalytical phase issues.
One of the main future activities of
this WG will be to organize the 2nd
EFLM-BD Conference on pre-analytical phase, during March 1-2, 2013, in
Zagreb, Croatia.
EFLM-AACB Agreement on the
Joint Task-and-Finish Working
Group on Critical Values (TFG-CV)
EFLM and AACB (Australasian Association of Clinical Biochemists) recognize the added value of working
together to foster cooperation and to
advance Laboratory Medicine. To formalize this cooperation a joint Taskand-Finish Working Group on Critical
Values (TFG-CV) has been established for a 2-year period.
Action points that are of mutual
interest to both parties are:
1) To expand the recent Australasian
survey on critical values management to Europe.
2) To publish results of the European
survey of critical value management jointly with AACB
3) Develop joint recommendations on
best laboratory practice for communicating critical results.
News from the Belgian Society
by Prof. J.P. Chapelle, Centre Hospitalier Universitaire de Liège,
Head of Medical Chemistry Service
uring the year 2011, the Royal
Belgian Society of Clinical Chemistry (RBSCC) organized a National
Symposium (Brussels, April 7, 2011) on
the topic “New and sensitive testing:
improving healthcare?” and, in collaboration with the Belgian Society of
Clinical Biology, a national meeting
(Liège, October 15, 2011) dealing with
“The added value of clinical-laboratory
interaction and The future of Clinical
Biology”.
Education is also a main objective of
the RSBCC. During the RRBSCC
National Symposium (April 7, 2011), two
trainees in Laboratory Medicine
received the Young Investigators Award
in Clinical Chemistry 2010-2011 for an
outstanding publication in the field of
applied clinical chemistry and in the field
of fundamental research. During the
D
BSCB/RBSCC joint National Symposium (October 15, 2011), three prizes
were awarded to young investigators for
a recently published article relating to
clinical biology.
In 2012, the National Symposium of
our society will be devoted to “Medical
quality beyond operational quality in the
lab: the role of Clinical Biologist.” The
meeting will be held in Groot-Bijgaarden
(Brussels) on May 3, 2012. (Information:
[email protected]). The joint National Symposium of the Belgian Society of
Clinical Biology will be organized in
Ghent on October 20, 2012.
On the international level, preliminary contacts have been made with the
organizers of the 2015 EFCC EuroMedLab Congress to be held in Paris
(France), in order to organize a satellite
meeting in Brussels.
LabMedica International
April/2012
40
INDUSTRY NEWS
OGT in Licensing Agreement for
12 Colorectal Cancer Biomarkers
xford Gene Technology (OGT;
Oxford, United Kingdom; www.
ogt.co.uk), provider of clinical genetics and diagnostic solutions, has
entered into an exclusive licensing
agreement with Inven2 (Oslo, Norway; www.inven2.com), the technology transfer office at Oslo University
Hospital (OUS; Oslo, Norway; www.
ous-research.no) and University of
Oslo (UiO; Oslo, Norway; www.
uio.no/english), for 12 promising colorectal cancer tissue biomarkers.
The DNA methylation biomarkers
were developed in the laboratory of
Prof. Ragnhild A. Lothe, in the department of Cancer Prevention, the Norwegian Radium Hospital, part of the
Oslo University Hospital. As a result of
the agreement OGT will be able to
O
commercialize any test developed
using these biomarkers and to sublicense the markers to other parties.
The results obtained in Prof.
Lothe’s laboratory were validated by
OGT, and demonstrated a sensitivity
of 93% and specificity of 90% when
using tissue biopsies. The efficacy of
the biomarkers in blood and fecal
samples is still being studied.
A robust preventive strategy for
colorectal cancer that can stratify
patients into appropriate screening or
surveillance programs is lacking for
early detection of cancer. Internationally, the chosen modality of
colorectal cancer screening varies,
with cost and availability of diagnostic resources likely to be the leading
factors effecting program design.
Report Predicts High Growth in
Personalized Medicine Testing
ersonalized medicine, or matching an individual patient to an
individual treatment, has long been
part of diagnostic testing. Matching a
drug’s effectiveness with a patient’s
genetics has been considered since
the 1950s. Blood testing, transplant
tissue testing, microbial identification, and antibiotic susceptibility
(AST susceptibility) are examples of
individualized testing that have been
part of medicine for many years.
According to healthcare market
research publisher Kalorama Information (Rockville, MD, USA; www.
kaloramaInformation.com), new vali-
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LabMedica International
April/2012
dated biomarkers, and the need to
improve target cancer therapy, increased personalized medicine testing
to a USD 28 billion market in 2011.
A new report by Kalorama
acknowledges that the current interest in in-vitro diagnostics (IVD), and
that a share of the growth in this market, is coming from new molecular
tests and the profiling of solid cancer
tumors. These are creating an entirely new paradigm for diagnosing and
choosing treatment options. The new
tests are driving the market to betterthan-average growth rates compared
to other segments of the IVD market.
BD Diagnostics Acquisition
Expands Microbiology Portfolio
D Diagnostics (Franklin Lakes,
NJ, USA; www.bd.com) has acquired Kiestra (Drachtan, the Netherlands; www.kiestra.nl), expanding
the company microbiology portfolio
to include new automated instrumentation technologies, which will
enable it to offer total lab automation
solutions to hospitals and laboratories
worldwide.
Kiestra Lab Automation BV, which
designs, develops, manufactures,
markets, and sells lab automation
solutions for the microbiology lab,
complements BD’s microbiology portfolio of instruments, reagents, and
supplies. Kiestra offers two lines of
automated solutions: Total Lab
Automation (TLA) and Work Cell
Automation (WCA). Total Lab
Automation is designed to significantly increase overall microbiology lab
productivity, streamline workflow,
and shorten the time to results.
Kiestra’s Work Cell solutions will
offer customers a modular and scalable approach to automate their lab
within current space and budget constraints.
“We look forward to joining the
BD team to expand automation
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across the entire microbiology and
infectious disease testing process,”
said Jetze Botma, vice president,
microbiology laboratory automation,
who served until the acquisition as
CEO, KIESTRA Lab Automation.
“Together with BD, we now have the
opportunity to integrate automation
across microbiology informatics,
instruments, and consumables for
maximum workflow efficiency, and
have access to the global arena.”
Kiestra Lab Automation BV, which
designs, develops, manufactures,
markets, and sells lab automation
solutions for the microbiology lab,
complements BD’s microbiology portfolio of instruments, reagents, and
supplies. Kiestra offers two lines of
automated solutions: Total Lab
Automation (TLA) and Work Cell
Automation (WCA). Total Lab
Automation is designed to significantly increase overall microbiology lab
productivity, streamline workflow,
and shorten the time to results.
Kiestra’s Work Cell solutions will
offer customers a modular and scalable approach to automate their lab
within current space and budget constraints.
LMI-04-12 141
INTERNATIONAL CALENDAR
For a free listing of your event, or a paid
advertisement in this section, contact:
International Calendar • LabMedica
P.O.Box 800806, Miami FL 33280-2410, USA
Fax: 1-954-893-0038
E-mail: [email protected]
Yellow-highlighted listings are available
at US$ 300 for a one-year period.
Please mail check with your event’s
details to above address.
APRIL 2012
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