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U.S. News

FDA OKs Second HIV Donor Screening Test

From U.S. Centers for Disease Control and Prevention

September 23, 2009

The Food and Drug Administration has approved a new test, the Abbott Prism HIV O Plus assay, that detects HIV antibodies in donated blood and organs. The test is one of five that run on Abbott's fully automated Prism System. FDA said the test identifies antibodies to HIV type 1, groups M and O, and to HIV type 2. It is the second donor screening test licensed to detect antibodies to HIV type 1, group O. Positive results for the test still require confirmatory supplemental testing, officials said.

Back to other news for September 2009

Adapted from:
United Press International
09.21.2009

  
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This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
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More on the FDA Drug Approval Process and Other Regulatory Issues

 

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