FDA Approves Rapid Test for Platelet Contamination
Test screens for harmful bacteria in blood platelets prior to transfusion
THURSDAY, Sept. 20 (HealthDay News) -- The U.S. Food and Drug Administration has approved a disposable test strip that can be used in hospitals to detect bacterial contamination of blood platelets prior to transfusions. The Platelet Pan Genera Detection Test System is made by Verax Biomedica Inc. of Worcester, Mass., and can be used to retest platelets shortly before use.
The test is designed to be used in conjunction with other quality control measures before platelets are used to prevent or treat patient bleeding during chemotherapy, after major trauma, or during or after surgery.
The test can be performed in 30 minutes. It is less sensitive than standard culture, but is used after platelets have been stored and it may pick up bacteria that may have multiplied in number prior to use.
"The clearance of a rapid test is a significant step in the detection of bacterial contamination of platelets for transfusion," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "In half an hour, a sample is prepared, processed and read, providing an additional assurance that the product is free from harmful bacteria."