FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
Experts to Re-examine Guidance for Platelet Testing
Fenwal, Inc. announced that the U.S. food and Drug Administration has cleared the Verax Platelet PGD(R) test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was developed by Verax Biomedical of Worcester, Mass.
Bacterial contamination in platelets is a serious threat to transfusion safety. More than 5 million platelet doses are transfused annually worldwide. Studies show that up to 1 in 2,000 doses may contain bacteria, which can cause a range of reactions, including death, especially in immune-compromised patients.
"Until now, there was no rapid test cleared by the FDA for detecting bacteria in whole-blood derived platelets," said Louis M. Katz, M.D., chair of international blood transfusion association AABB 's Task Force on Bacterial Contamination. "With such a test now available, we will reexamine the current Standards regarding 'methods to limit and to detect bacteria in all platelet components."
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