FDA approves first dual test for Hep B

The Food and Drug Administration (FDA) today announced the approval of the first fully automated product that combines both screening and confirmatory 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. The test also may be used to screen blood from cadavers for organ and tissue donation. The Abbott PRISM HBsAg Confirmatory assay is approved for the confirmation of samples found to be reactive by the Abbott PRISM HBsAg assay. Currently, screening and confirmatory tests are performed separately.

“This automated test system increases the efficiency and convenience of screening blood, tissue and organ donors for the hepatitis B virus,” said Jesse Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research. “Improvements in blood donor screening and testing over the last few years have helped make the nation’s blood supply safer from infectious diseases than it has been at any other time.”

Hepatitis B is caused by a virus that infects the liver. The virus, which is transmitted by blood, can, in some cases, cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure and death. A blood test is the only way to determine if a donor has hepatitis B infection.

The Abbott PRISM HBsAg tests are fully automated, reducing the potential for operator errors. They are also tamper-resistant, with redundant checks to ensure integrity of the testing system, and highly sensitive and specific for detection of HBsAg.

From U.S. FDA