FDA approves automated hepatitis B test

July 19, 2006

The U.S. Food and Drug Administration has approved the first automated product combining screening and confirmatory tests for hepatitis B surface antigen.

The Illinois-headquartered Abbott Laboratories' PRISM HBsAg assay was 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 FDA said the assay also was approved for the confirmation of samples it found to be reactive. 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 Dr. Jesse Goodman, 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."

Hepatitis B, caused by a virus that infects the liver, can only be determined by a blood test.

Copyright 2006 by United Press International

Explore further: Researchers create smartphone-based device that reads medical diagnostic tests quickly and accurately

Related Stories

Carlyle Group makes $4.15B offer for J&J business

January 16, 2014

Johnson & Johnson said Thursday that it's been offered $4.15 billion by The Carlyle Group for its Ortho-Clinical Diagnostics business, a year after J&J began reviewing strategic options for the blood-testing unit as part ...

Most detailed picture ever of key part of hepatitis C

November 28, 2013

Scientists at The Scripps Research Institute (TSRI) have determined the most detailed picture yet of a crucial part of the hepatitis C virus, which the virus uses to infect liver cells. The new data reveal unexpected structural ...

Target 'super-spreaders' to stop hepatitis C

January 31, 2013

Each intravenous drug user contracting Hepatitis C is likely to infect around 20 other people with the virus, half of these transmissions occurring in the first two years after the user is first infected, a new study estimates.

Recommended for you

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.