Laboratory News

Innovative Rapid Blood Screening Test Becomes FDA Approved

Recently, the Food and Drug Administration (FDA) announced its approval of the first rapid test to detect bacterial contamination in blood platelets prior to transfusion.  This technology is designed to supplement existing initial screenings of blood donations.  It provides a quick procedure to screen blood shortly before it is used for a transfusion to determine if any contamination or bacterial growth has occurred during storage. 

The rapid test is a disposable strip hospitals can use to test blood shortly before a patient receives platelets from the blood.  The test, known as the Platelet Pan Genera Detection, or PGD, Test System, is made by Verax Biomedical Inc of Worcester, Massachusetts.  According to the company, this assay uses proprietary technology to test for common antigens found on the surface of all species of bacteria known to be pathogenic to humans. The test cuts the detection time for bacterial contamination in leukocyte reduced aphaeresis platelets to approximately 30 minutes.

From the Verax press release:  The clearance comes on the heels of the execution of key agreements with Abbott Diagnostics  to serve as distributor and British Biocell International  to serve as manufacturer of the product. The data from US clinical studies that served as the basis of the Company's 510 (k) filing were featured in 7 poster presentations at the Annual Meeting of the American Association of Blood Banks (AABB) in Anaheim, California October 20th - 23rd.

Interest in tests such as this new Platelet Pan Genera Detection test is high, because, according to the FDA, bacterial contamination of platelets is the leading infectious cause of transfusion-related deaths. There is a 1 in 5,000 risk that a patient will receive a transfusion contaminated with bacteria. For the laboratory industry, FDA approval of this rapid test demonstrates how advances in technology are leading to diagnostic assays that can be performed outside the core lab and shorten the time needed to produce a result.

Related Articles:

• Rapid Blood Test Cleared
• Verax Biomedical Receives 510 (k) Clearance from FDA for Platelet PGD Test