| bioMérieux®
INDUSTRY offers increased safety of the blood supply with BacT/ALERT®,
now FDA cleared for platelet testing
DURHAM, NC October 22, 2002 – bioMérieux INDUSTRY
is pleased to announce that its BacT/ALERT system recently received
marketing clearance from the U.S. Food and Drug Administration
for quality control testing of leukocyte reduced apheresis platelet
(LRAP) units.
From 1990 to 1998 in the U.S., 17% of transfusion-associated
fatalities were caused by bacterial contamination.1
In light of the current platelet preparation process, the risk
of adverse events due to apheresis platelet transfusion is three
times higher than that of red blood cell transfusion. Mortality
is seven times higher in apheresis platelet transfusion compared
to red blood cell transfusion.
The automated BacT/ALERT system has been used for over ten years
in clinical laboratories to detect microorganisms from normally
sterile specimens such as blood and body fluids. More recently,
blood collection and transfusion centers across the world have
been evaluating BacT/ALERT in their laboratories to test platelets.
BacT/ALERT is an ergonomic, compact and user-friendly system.
Its stackable modules take up little room in the laboratory and
can be set on the lab counter, on a separate cart or stacked using
racks. The system detects growth rapidly, is easy-to-use, and
requires minimal operator intervention or training.
BacT/ALERT automatically detects the presence of bacteria by
tracking their production of CO2.
A sensor at the bottom of the culture bottle containing the specimen
indicates the presence of CO2
by changing color, from gray to yellow. The system then notifies
the laboratory of a positive sample with visual and audible alarms.
In the hands of a blood collection center, a negative predictive
value of 99.97% and a specificity of 99.8% were found. 2
BacT/ALERT features rapid detection time - generally less than
24 hours, with a range from 9.2 hours to 25.6 hours.3
The BacT/ALERT is sensitive and reliable for quality control testing
of leukocyte reduced apheresis platelet (LRAP) units.
bioMérieux is based in France and specializes in infectious
disease diagnostics, coagulation diagnostics, and industrial microbiology
control. It is the eighth-largest biological diagnostics company
in the world and is the international leader in the field of microbiology.
Contact:
For more information on the BacT/ALERT system and quality
control testing of LRAP units, call bioMérieux U.S. Customer
Service at 1-800-634-7656.
References:
1. Lee J.H. (1999, September 24). FDA CBER workshop
on bacterial contamination of platelets
2. Laan, E., Tros C. Improved safety and extended shelf-life of
leuco-depleted platelet concentrates by automated bacterial screening.
Transfusion, 1999;5S Supplement
3. Brecher M.E., Heath D.G., Hay S.N., Rothenberg S.J. and Stutzman
L.C. Evaluation of a new generation of culture bottle using an
automated bacterial culture system for detecting nine common contaminating
organisms found in platelet components. Transfusion, 2002;42:774-779
• AABB Weekly Report. Volume 8, Number 29, August 16, 2002
• Lui, H., Yuen, K., Cheng, T. S., Lee, K., Chua, E. K.,
Ho, P., et al. Reduction of platelet transfusion-associated sepsis
by short-term bacterial culture. Vox Sanguinis, 1999;
77(1), 1-5.
• Schelstraete, B., Bijnens, B., Wuyts G. Oral presentation:
Prevalence of bacteria in leuco-depleted pooled platelet concentrates
and apheresis platelets: current status in the Flemish blood service.
AABB 53rd Annual Meeting, 2000, November 4, Washington, D.C.
• De Korte. Oral presentation. Universal culturing of platelet
concentrates; the “European” experience. ISBT, 2002,
August 26, Vancouver, Canada.
• Bjork, P. Symposium on the non-sterility of blood and
blood components in blood banks. Luxembourg, 1997.
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