AEGiS-Miami Herald: FDA approves only one HIV home test kit

Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.

FDA approves only one HIV home test kit

Miami Herald - February 1, 2008

Privacy and confidentiality are the main reasons that lead people to choose home-testing kits to find out if they're infected with HIV, the virus that causes AIDS, the Food and Drug Administration says. It's reminding consumers that there's only one product currently approved by the FDA and legally sold in the United States as such a kit. It's marketed as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System."

The kit contains a home collection-test system that requires users to collect a blood specimen and then mail it to a laboratory for professional testing; no test kits allow consumers to interpret the results at home.

Numerous unapproved test systems are currently being marketed, the FDA says. Manufacturers have falsely claimed that their products can detect antibodies to HIV in blood or saliva samples, and that they can provide results in the home in 15 minutes or less. Some have even claimed that their systems have FDA approval or are manufactured in a facility that's FDA-registered. Learn more at www.fda.gov/consumer.

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