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