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FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
Date:11/17/2009

he 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.

"We are pleased that Verax has received clearance for use of the Platelet PGD® test on whole blood platelets," said Darrell Triulzi, M.D., medical director of the Institute for Transfusion Medicine and the University of Pittsburgh Medical Center's Division of Transfusion Medicine. "We are a large user of pooled platelets and have sought a more sensitive method for bacterial screening. The Verax test from Fenwal fills this role with a point-of-issue test that we are confident will reduce the risk of bacterial-contamination reactions. Our preliminary experience indicates that it works well in the transfusion service work flow and that the technologists who administer the test find it easy to use."

Platelets are collected from whole-blood donations or via apheresis. With whole-blood donations, platelets from four to six whole-blood donors are pooled to produce a single, transfusion dose. In an apheresis platelet donation, a single donor can give one or more transfusion doses of platelets via a machine such as the Fenwal Amicus® separator.

In September 2007, Verax received FDA clearance to market the Platelet PGD® test as an adjunct test to detect bacteria in leukocyte-reduced, apheresis platelets following culture testing by an FDA-cleared test. Recent studies, including post-market surveillance from Verax, show that up to 70 percent of units containing bact
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SOURCE Fenwal, Inc.
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