Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD® test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was developed by Verax Biomedical of Worcester, Mass.
The Verax Platelet PGD® test is the only rapid diagnostic test to receive FDA clearance for detecting bacteria in both pooled and single-donor platelets. The test can be performed in approximately 30 minutes and is designed for use in hospitals, cancer centers and other sites of care as a safeguard prior to transfusion.
Bacterial contamination in platelets is a serious threat to transfusion safety. More than 5 million platelet doses are transfused annually worldwide. Studies show that up to 1 in 2,000 doses may contain bacteria, which can cause a range of reactions, including death, especially in immune-compromised patients.
The international blood transfusion association AABB (www.aabb.org) issued an Association Bulletin in July 2009 stating that "after publication of data sufficiently robust to support application of an assay appropriate for use near the time of platelet issue, the current standard will be reappraised. At that time, AABB intends to promulgate an interim standard to require enhanced methods of bacterial detection in WBD platelets--either by specifically prohibiting the use of less sensitive methods such as pH or glucose, or by establishing a minimum sensitivity level for methods used to detect bacteria." The Verax Platelet PGD® test is an example of such an assay.
"Until now, there was no rapid test cleared by the FDA for detecting bacteria in whole-blood derived platelets," said Louis M. Katz, M.D., chair of AABB's Task Force on Bacterial Contamination. "With such a test now available, we will reexamine the current Standards regarding 'methods to limit and to detect bacteria in all platelet components.'"
AABB member facilities are responsible for collecting virtually all of America's blood supply and transfusing more than 80 percent of all blood and blood components in the United States. The organization's members operate in 80 countries worldwide.