ARTICLE | Regulation
Harried FDA panel votes 'yes' and 'no'
June 24, 1996 7:00 AM UTC
BETHESDA, Md. - An FDA advisory panel delivered a confusing verdict on Friday about the use of Western blot tests for detecting HIV-1 antibodies in urine, a critical component of a urine-based AIDS test that Calypte Biomedical Corp. is seeking to market.
The Blood Products Advisory Committee voted 8-1, with 3 abstentions, that Calypte's test, when supported by detection of a single gp160 envelope protein band on the urine Western blot test, is sufficient to indicate a positive test result...