FDA approves blood platelet bacterial test

WASHINGTON, Sept. 18 (UPI) -- The U.S. Food and Drug Administration has approved for marketing the first pretransfusion rapid blood platelet bacterial contamination test.

The Platelet Pan Genera Detection Test -- a disposable test strip for use by hospital transfusion technicians -- is intended to supplement current quality-control testing methods.

"The clearance of a rapid test is a significant step in the detection of bacterial contamination of platelets for transfusion," said Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research.

Blood platelets are used to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, after major trauma, during or after surgery and in individuals who don't produce platelets, the FDA said. Patients who are transfused with platelets contaminated with bacteria are at risk of developing serious and potentially life-threatening infections of the blood stream.

Bacterial contamination of platelets is the leading infectious cause of transfusion-related patient fatalities.

Although the new test system is less sensitive than standard cultures, it is done later in storage when bacteria, if present, have multiplied and thus are easier to detect, the FDA said.

The rapid test was developed by Verax Biomedica Inc. of Worcester, Mass.