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FDA Approves First Automated Hepatitis B Test

The Abbott Prism hepatitis B surface antigen test combines screening and confirmatory tests

WEDNESDAY, July 19 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first automated test for the hepatitis B surface antigen that combines both screening and confirmatory testing for the hepatitis B virus.

In contrast to current procedures that involve separate screening and confirmatory tests, the Abbott Prism hepatitis B surface antigen test combines both procedures, according to the FDA.

The new combined test can be used to test blood and organ donors, as well as cadavers used as sources of human organs and tissue.

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

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