The US Food and Drug Administration (FDA) has cleared for marketing the first rapid test to detect bacterial contamination in leukoreduced apheresis platelets prior to transfusion.
The platelet pan genera detection (PGD) test system is a disposable test strip for use in a hospital transfusion service setting.
It is intended to supplement current quality control testing methods of platelets following collection.
The clearance of this test is a significant advancement in detecting bacterial contamination of platelets, according to Jesse L. Goodman, MD, MPH, 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,” Dr Goodman said.
Bacterial contamination of platelets is the leading infectious cause of transfusion-related patient fatalities. The risk of a patient receiving a transfusion contaminated with bacteria is 1 in 5,000, far greater than the risk of transmitting hepatitis C (1 in 1.6 million) or HIV (1 in 1.9 million).
To reduce the risk of transfusing contaminated platelets, blood centers culture samples of the platelets 24 hours after the donation. The culture is read within 48 hours of donation, and contaminated units are discarded.
However, there is a possibility that the number of bacteria present at the time of culture may be so low that bacteria are not detected due to sampling limitations.
Rapid testing of platelets using the platelet PGD test system permits units of platelets to be retested at a time closer to their use. Although the test system is less sensitive than standard cultures, it is done later in storage when bacteria, if present, have multiplied and are therefore easier to detect.
The platelet PGD test system was developed by Verax Biomedica Inc., Worcester, Massachusetts.
