The US Food and Drug Administration (FDA) has expanded the authorized use of Verax Biomedical’s Platelet PGD Test, which detects bacteria in platelets intended for transfusion.
The FDA previously approved the test for leukocyte-reduced apheresis platelets (in 2007) and platelets derived from whole blood (in 2009).
Now, the test has been approved for pre-storage pooled platelets and apheresis platelets in platelet additive solution C (PAS-C) and plasma.
This makes the Platelet PGD Test the only rapid test on the market that can check every commonly distributed platelet type in the US, according to Verax Biomedical.
About the test
The Platelet PGD Test is an immunoassay used on the day of transfusion at the point of care—a hospital or transfusion service—to detect bacterial contamination in platelets to be transfused.
The test consists of a disposable plastic cartridge and 3 pretreatment reagents. To use, the tester pretreats a freshly collected platelet sample (500µL) and applies it to the sample well on the test cartridge.
Lights on the cartridge change from yellow to blue-violet when the test is ready to be interpreted, which is typically about 20 minutes after the sample is applied to the cartridge. The lights confirm that the appropriate volume of a sample was added and the testing is complete.
If the test is positive, a pink line will appear in 1 of the 2 windows on the cartridge. One window represents Gram-positive bacteria and the other Gram-negative. Non-reactive samples will have no line in either window.
Now that the FDA has expanded the indications for the Platelet PGD Test, it can be used as a quality control test for pools of up to 6 units of leukocyte-reduced and non-leukocyte-reduced whole-blood-derived platelets suspended in plasma that are pooled within 4 hours of transfusion.
The test can also be used within 24 hours of transfusion as a safety measure following testing with a growth-based, quality control test cleared by the FDA. For this indication, the Platelet PGD Test can be used with:
- Leukocyte-reduced apheresis platelets suspended in plasma
- Leukocyte-reduced apheresis platelets suspended in PAS-C and plasma
- Pre-storage pools of up to 6 leukocyte-reduced whole-blood-derived platelets suspended in plasma.
In studies conducted by Verax Biomedical (described in the summary document here), the Platelet PGD Test successfully detected bacteria in pre-storage pools of whole-blood derived platelets suspended in plasma and leukocyte-reduced apheresis platelets suspended in plasma or PAS-C and plasma.
