The BD Viper™ System with
XTR™ Technology
Introducing the BD Viper™ System
with XTR™ Technology
Designed to meet the challenges
faced by today’s laboratory
Paired with our FDA cleared
assays, BD Viper provides
a comprehensive STI solution
for your laboratory
Molecular labs encounter a
diverse set of challenges
Economic
Constraints
Decentralized
Testing
Unreliable
Results
By design, the BD Viper™ System provides a cost-effective solution
ideal for an economically-constrained environment
• Requirements to
do more with less
Unequivocal Results
• Limitations on
skilled workforce
• Budgetary
constraints
Minimized
Waste &
Economic
Benefits
Optimized
Productivity
Minimizing waste is one way the BD Viper™
solution delivers economic benefits
Improving Economic Value –
both personnel and
non-personnel costs
• No refrigeration required
• No reagent preparation
• Single unit, ready-to-use
reagents
• Mixed batch capability
The BD Viper™ eliminates the equivocal zone found in other
FDA cleared assays – delivering confidence in results
NO EQUIVOCAL ZONE
Reducing the need for retesting
Cutoff of ≥125 MaxRFU
Cutoff of ≥125 MaxRFU
Source: Package insert for BD CT/GC Qx assays
The Gen-Probe® Aptima® CT/GC have equivocal zones
for both CT and GC that require retesting
• Result can be either:
•
•
•
Positive
Negative
Indeterminate/Equivocal
• Initial equivocal and invalid test
results should be retested
• Could cause delays, increased
costs and potential false positives
Data from Aptima Combo 2® Package Insert
Relative Light Units (RLU)
The BD Viper™ focuses on productivity, decreasing
required hands on time and overall unproductive time
Source: Internal studies
The BD Viper™ maximizes productivity, decreasing
required hands on time and overall unproductive time
Simulation
Cycle Time*
Hands-On Manual Labor Time**
*
BD Viper
XTR
Gen-Probe
TIGRIS
3:24:00
6:06:00
0:24:00
0:54:00
Simulated time includes time to release results
* Total cycle time: Time to perform testing on the volume of specimens; this includes all manual and automated pre-analytical
(laboratory accessioning is not included), analytical and post-analytical activities (time ends when consumables and specimens have
been removed from the instrument, and specimens have been disposed of or prepared for storage)
** Hands-on Manual labor time: The daily amount of time that lab personnel must devote to physically performing testing; this
includes pre-analytical, analytical and post-analytical manual labor (it does not include maintenance activities)
Source: Internal studies
Testimonial – Economic Benefits
“The BD Viper™ System with XTR™ Technology is all
about automation and freeing up labor. It has improved
our productivity with less staffing. Today, we’re running
about 24,000 CT/GC tests a year with one-half FTE.”
MICHAEL LOEFFELHOLZ, PhD, UNIVERSITY OF TEXAS MEDICAL
BRANCH, GALVESTON, TX
The BD Viper™ System provides an opportunity to consolidate
testing requirements as well as service/technical points of contact
• Multiple workstations for
testing requirements
Most Sample Types
• Multiple technologies
& points of contact
Workstation
Consolidation
Standardized
Workflow
A wide variety of specimen types increases
the flexibility of sample collection
The BD Viper™ System leads the CT/GC market
in sample type availability
Swab
CT/GC Assays
Male
Endocervical Urethral
Urine
Vaginal
Male
Neat
Male
Transport
Female
Neat
Liquid Based Cytology Media
Female
Transport
Hologic PreservCyt
PrePostAliquot
Aliquot
BD SurePath
PrePostAliquot
Aliquot
BD Qx
Abbott Real Tim e
Gen-Probe Aptima
Roche Cobas
“It was important that the CT/GC assays were FDA cleared for both
SurePath and ThinPrep collections. With the Viper, it’s easier to
validate these tests because of the FDA clearance. We are looking
at adding HSV testing because it is FDA cleared on the Viper”
GARY GEMAR, INCYTE PATHOLOGY, SPOKANE VALLEY, WA
The BD Viper™ System has 5 FDA-cleared STD assays and is
able to efficiently run tests based on your unique requirements
TIGRIS
2
CT/GC
Trich
Abbott m2000
# of Runs
CT/GC only
1
Roche 4800
CT/GC Only
Viper XTR
CT/GC, Trich & HSV 1 &2
Time
Minimal pre- & post-analytical hands-on time
frees up valuable lab professional time
Instrument development considered the customer’s
needs throughout the design of the product
Pre-analytical time for 4 runs
1 Hour (15 minutes/run)
FTE per shift (for 4 runs)
13%
Post-analytical time for 4 runs
40 minutes (10 minutes/run)
Pre & post-analytical hands-on time per run
25 minutes
Tech time/results
4.9 seconds
*
*Data in table from Felder, Robin A. et. al “Process Evaluation of a Fully Automated
Molecular Diagnostics System.” Journal of the Association for Laboratory Automation,
October 01 2009
Testimonials: Efficiency Gains
“Since we brought testing in house, we are totally
in control of turnaround time. Not only are we
bringing in more revenue, we are also getting
results out a day or two faster.”
GARY GEMAR, INCYTE PATHOLOGY, SPOKANE VALLEY, WA.
“With the acquisition of our second Viper system, BD
provided LEAN consultation and workflow analysis.
We were able to design a more efficient process that
made it very easy to get up and running smoothly.”
PAUL LEPHART, PhD, DETROIT MEDICAL CENTER UNIVERSITY
LABORATORIES, DETROIT, MI.
The BD Viper™ System design works to
minimize Unreliable Results
• Uncertainty surrounding
the accuracy of results
• Disruptive repeat testing
Extraction Process Control
No
Equivocal
Zone
Total
System
Integrity®
Control Over Workflow Process: Reassure consistency
of performance during testing and every single test
The BD Viper™ System ensures control throughout the test run
The BD Viper System utilizes a special oligonucleotide labeled with a different dye to confirm the
validity of our proprietary BD FOXTM DNA extraction process. EC fluorescence is monitored and an
automated algorithm is applied to both the EC and target-specific signals to report specimen results as
positive, negative, or EC failure. This assures the results you report are high quality and reduces the
costs and issues associated with inappropriate treatment and retesting.
BD Qx technology 96 samples, 100% control
Gen-Probe TIGRIS example for 100 samples
•
•
•
A positive and negative control (per plate) are tested
simultaneously with all samples.
Every single sample reaction has a process control to
monitor performance of individual tests.
•
•
Control bracketing. The system tests a control set and
then tests sequentially 100 samples.
This is happening across 4 hours and through 20
different testing processes.
At the end the system tests a new set of controls. If
successful then releases the results.
There is not a single control to reassure system
performance across 4 hours of testing.
Source: Package inserts for Gen-Probe and BD CT/GC Qx assays
Assurity Linc™: Dependability and remote service capabilities
deliver high reliability and minimize downtime
Unlike the competition, the BD Viper™ assays provide a
definitive yes or no answer for positive or negative results
BD CT/GC Qx Assay
Gen-Probe Assay
Source: Package inserts for Gen-Probe and BD CT/GC Qx assays
Testimonials: High Quality Results
“We’ve not had any evidence of lab contamination
since moving the testing to the Viper … and it
really contributes to peace of mind”
MICHAEL LOEFFELHOLZ, PhD, UNIVERSITY OF TEXAS MEDICAL
BRANCH, GALVESTON, TX
“I have no doubt we’re putting out high
quality results”
DAVID BANKERT, YORK HOSPITAL LABORATORY, YORK, PA
Why Choose the BD Viper™ System?
Our solutions lead the market in addressing the
challenges within your laboratory
With a BD partnership, you
can depend upon the following:
• Unparalleled service and support
• A commitment to continuing education
and to your laboratory’s success
• Continued customer driven
development of instruments & assays
BD: A Trusted Partner with a Long
History of Innovation and Stewardship
Since 1897, BD has been a leading force in
innovating medical devices, equipment and
diagnostic products. Our purpose is Helping all
people live healthy lives, and we do so by
developing and manufacturing medical
devices, instrument systems and reagents that
combat many of the world’s pressing diseases.
For more than a century, BD has earned
customers’ trust by effectively and efficiently
developing and manufacturing high quality
products that meet their needs. When you use
a product with the BD name on it, you are
using a product you can trust.