The U.S. Food and Drug Administration (FDA) has given it's approval for the first rapid test to detect bacterial contamination in blood platelets prior to transfusion.
The test, called the Platelet Pan Genera Detection (PGD) Test System is a disposable strip for use in a hospital transfusion service setting and is meant to supplement quality control testing methods currently in use.
The FDA says the test is a significant step in the detection of bacterial contamination of platelets for transfusion; in 30 minutes a sample is prepared, processed and read, providing an additional assurance that the product is free from harmful bacteria.
Blood platelets are used to prevent or treat bleeding in those undergoing chemotherapy for cancer, following a major trauma, during or after surgery, and also for individuals who do not produce their own platelets.
Transfusions with platelets which are contaminated with bacteria places a patient at risk of developing a serious and potentially life-threatening infection of the blood stream known as blood poisoning.
In order to prevent the infection from spreading to the heart and lungs, blood poisoning has to be treated quickly; the bacterial contamination of platelets is the leading infectious cause of transfusion-related patient deaths.
The risk of a patient receiving a transfusion contaminated with bacteria is 1 in 5,000, with hepatitis C virus, one in 1.6 million, or HIV, one in 1.9 million.
To avoid transfusing contaminated platelets, blood centers culture samples of the platelets 24 hours after the donation and the culture is read within the next 24 hours.