The U.S. Food and Drug Administration (FDA) approved the first rapid test to scan donated blood platelets for dangerous bacteria. The Platelet Pan Genera Detection (PGD) Test System, developed by Verax Biomedica Inc., of Worcester, MA, comes in the form of a disposable strip and can be carried out quickly and efficiently prior to the platelet transfusion.
Platelet transfusions are normally given to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, following major trauma, during or after surgery, and in patients who do not produce platelets. However, platelet transfusions carry risks. According to the FDA, bacterial contamination of platelets is the leading infection-related cause of transfusion-associated deaths. The bacteria can cause blood poisoning, a life-threatening infection in the bloodstream that can spread to the heart and lungs. The likelihood of a patient receiving a bacteria-contaminated transfusion is 1 in 5,000.
PGD is not meant to be a stand-alone test but an additional check after blood centers have already screened platelets. Centers typically sample cultures of platelets 24 hours after donation, analyze test results within the next 24 hours and then dispose of any contaminated units. The amount of bacteria found during this process is sometimes so low that it goes undetected. The PGD test of the sample is used closer to the time of the transfusion, when the bacteria population may have grown and become detectable.
Officials at the FDA pointed to the added safety and quick turnaround time of the test. “The clearance of a rapid test is a significant step in the detection of bacterial contamination of platelets for transfusion,” said Jesse L. Goodman, MD, MPH, 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.”
Read the entire FDA release