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Testing (HIV)

U.S. Government Moves Against HIV Test Kits

Published in AIDS Weekly, November 29th, 1999

Two U.S. agencies warned consumers on November 17, 1999, that home test kits for the AIDS virus may not give accurate results, and said it was acting against people and companies selling unapproved test kits.

Only one kit is approved for home use, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) said in a statement. That is the "Home Access Express HIV-1 Test System," made by Home Access Health Corp.

"The approved HIV test has been carefully reviewed by the FDA to ensure that the test system is capable of yielding accurate, dependable results," Steven Masiello of the FDA's Center for Biologics Evaluation and...

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