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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Epitope Receives FDA Approval to Sell AIDS Test That Uses Saliva, Not Blood
Wall Street Journal (12/27/94) P. B4 Richards, Bill
After three and a half years of review, the Food and Drug Administration (FDA) has given approval to Epitope Inc. to begin marketing the first test to use saliva rather than blood to detect HIV. The test, called OraSure, is also the first to be cleared by the FDA for collecting oral specimens for disease diagnosis of any type. Supporters of the test claim that a saliva-sample test would increase the number of people tested. The test, which comes in kit form and takes about two minutes to administer, has two components: a treated cotton pad on a stick to collect saliva, and a specific test to analyze the specimen for HIV antibodies. In a statement on Friday, the FDA said Epitope's oral HIV test is less accurate than blood samples. The oral tests show false negatives in one to two of every 100 individuals with HIV and false positives for two out of every 100 without HIV, added the agency. The FDA also placed several restrictions on Epitope's test: the test system may be bought and distributed only through doctors and administered only by people trained in its use; the test is not intended for home use; and it may be used for diagnosis only, not to screen blood donors. Epitope plans to begin marketing the HIV test kits within six weeks. Related Stories: Baltimore Sun (12/24) P. 3A; Washington Post (12/24) A7
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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
