FDA Clears First Rapid Test for Bacterial
Contamination in Pooled Platelets
Seniors should see lower risk from blood therapy often used
for those undergoing chemotherapy, surgery
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Read more
about Platelets below article. Art from Circulation -
Journal of American Heart Assn. |
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Nov. 13, 2009 - Adding to the platelet supply to
treat or prevent bleeding in those with dangerously low platelet counts
primarily senior citizens undergoing chemotherapy for cancer,
suffering major trauma, or having surgery, and in individuals who do not
produce adequate numbers of platelets should be a lot safer after the
Food and Drug Administration today cleared the Platelet PGD Test System
for marketing.
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Read the latest news on Senior
Health & Medicine |
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This is the first rapid test to detect bacterial
contamination in pooled platelets derived from whole blood, according to
the FDA.
Platelets have the potential to be contaminated
with bacteria and it is important to detect and interdict such
contamination before transfusion. Patients who are transfused with
contaminated platelets are at risk of developing serious and potentially
life-threatening infections.
The Platelet PGD Test System consists of a
single-use test strip that, in fewer than 60 minutes, produces a signal
that indicates the presence of bacteria. The test is intended for use
mainly by hospital transfusion services as a quality control test for
the detection of bacteria after platelets derived from whole blood have
been pooled, just prior to a patient blood transfusion.
Bacterial contamination of platelets is the
leading infectious cause of patient fatalities associated with platelet
transfusions, said Karen Midthun, M.D., acting director of the FDAs
Center for Biologics Evaluation and Research.
A rapid test for pooled platelets is an important
step in improving safety for patients who are transfused with
platelets.
Clinical studies showed that the Platelet PGD Test
System improved the sensitivity for detecting bacterial levels by 100 to
1000-fold over existing methods used to test pooled platelets prior to
transfusion.
The Platelet PGD Test System is manufactured by
Verax Biomedical, in Worcester, Mass.
Helpful Information
from
MedlinePlus
About Platelet Disorders
Also called: Thrombocyte disorders
Platelets help wounds heal and prevent bleeding by
forming blood clots. Your bone marrow makes platelets. Problems can
result from having too few or too many platelets, or from platelets that
do not work properly.
If your blood has a low number of platelets, you
can be at risk for mild to serious
bleeding. If your blood has too many platelets, you may have a
higher risk of blood clots. With other platelet disorders, the platelets
do not work as they should. For example, in von Willebrand Disease, the
platelets cannot stick together or cannot attach to blood vessel walls.
This can cause excessive bleeding.
Treatment of platelet disorders depends on the
cause.
>>
More at National Heart, Lung, and Blood Institute
More About Platelets
Platelets are specialized disk-shaped cells in the
blood stream that are involved in the formation of blood clots that play
an important role in heart attacks, strokes, and peripheral vascular
disease. In most people, the more than 200 million platelets in a
milliliter of blood act as tiny building blocks to form the basis of a
clot to stop bleeding from cuts or injuries. Platelets can detect a
disruption in the lining of a blood vessel and react to build a wall to
stop bleeding
Circulation - Journal of American Heart
Association - Platelets and Cardiovascular Disease by David Gregg, M.D.,
and Pascal J. Goldschmidt-Clermont, M.D. (2003)
>>
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