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FDA Approves Automated HBV Test


ROCKVILLE, Md. -- The FDA has approved the first completely automatic test that both screens for the presence of hepatitis B and confirms it.

ROCKVILLE, Md., July 19 -- The FDA has approved the first completely automatic test that both screens for the presence of hepatitis B and confirms it.

The PRISM assay, developed by Abbott Laboratories, performs the detection and confirmation tests for hepatitis B surface antigen (HBsAg) that are currently done separately, the FDA said.

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

According to the CDC, one in 20 Americans will be infected with hepatitis B over a lifetime. The surface antigen HBsAg will be detectable in the blood on average about four weeks after exposure to the virus, although this can be as short as one week or as long as nine. The presence of the antigen means the person tested is infectious.

The PRISM instrument automates much of the manual testing now used to screen blood. The system includes the ability to track and monitor each sample throughout the testing process. It can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift, the company said.

"This automated test system increases the efficiency and convenience of screening blood, tissue and organ donors for the hepatitis B virus," said Jesse Goodman, M.D., director of the 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," Dr. Goodman said.

In the U.S., the CDC estimates, about 1.25 million people have a chronic hepatitis B infection.

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