HIV Diagnosis

First assay to include detection of HIV-1 group O gets premarket approval

Published in Medical Letter on the CDC and FDA, August 10th, 2003

bioMerieux, Inc. has received premarket approval from the U.S. Food and Drug Administration (FDA) for the Vironostika HIV-1 Plus O Microelisa System.

The device is used for qualitative detection of antibodies to HIV-1, including Group O, in human specimens collected as serum, plasma or dried blood spots, as an aid in the diagnosis of infection with HIV-1.

The Vironostika HIV-1 Plus O Microelisa System is the first Group O-sensitive test to receive FDA premarket approval, according to the company.

The FDA asked diagnostic test manufacturers to improve detection of HIV-1 Group O in 1996, following confirmation of the first case in...

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Source: Medical Letter on the CDC and FDA (2003-08-10)

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