The test, known as the Platelet Pan Genera Detection, or PGD, Test System, is made by Verax Biomedical Inc., of Worcester, Massachusetts and involves a disposable strip. This would be used in hospitals to test blood shortly before a patient receives platelets from the blood.
According to the FDA, the test is intended to supplement tests used by blood establishments following collection of platelets. Usually, blood centers sample cultures of donated platelets 24 hours after donation, read the tests in the next 24 hours and then discard any contaminated units. However, the FDA says there is a possibility that the number of bacteria present at the time of culture may be so low that bacteria can't be detected. Here the rapid test helps, as it would be able to pick up bacterial contamination closer to the time the blood might be used.
"The clearance of a rapid test is a significant step in the detection of bacterial contamination of platelets for transfusion," says Jesse L. Goodman, director of the 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."
Platelets are used to prevent or treat bleeding in people undergoing chemotherapy for cancer, after major trauma, during or after surgery and in individuals who don't produce platelets on their own. Patients who are transfused with platelets contaminated with bacteria are at risk of developing blood poisoning, which can be life-threatening.
According to the FDA, bacterial contamination of platelets is the leading infectious cause of transfusion-related deaths. The risk of a patient receiving a transfusion contaminated with bacteria is 1 in 5,000.