FDA APPROVES ABBOTT'S AUTOMATED DIAGNOSTIC FOR HEPATITIS B SURFACE ANTIGEN

The FDA July 18 said it had approved the first fully automated product that both screens and confirms tests for hepatitis B surface antigen (HBsAg).

The Abbott PRISM HBsAg assay is approved to test people who donate blood, blood components and organs for the hepatitis B virus, and may also be used to screen blood from cadavers for organ and tissue donation, the FDA said.

Currently, screening and confirmatory tests are performed separately. The test should increase the efficiency and convenience of screening donors for the hepatitis B virus, enhancing the safety of the nation's blood supply, an FDA official said.

The approval notice can be viewed at www.fda.gov/bbs/topics/NEWS/2006/NEW01411.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01411.html).