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FDA Approves New Home Test Kit for HIV

A private and rapid test for the virus that causes AIDS could encourage people with HIV infection to seek earlier medical care.

The Food and Drug Administration approved a new HIV test on Jul. 3 that will enable Americans to test themselves in the privacy of their own homes, with results obtained within 40 minutes.

The rapid test, consisting of a simple cheek swab, will make it easier for people to learn their HIV infection status, and obtain earlier medical treatment.

“If this enhances the number of people you can get into care, the advantages outweigh any objections,” Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview.

Getting infected people on antiretroviral drugs earlier can reduce the chance of passing the virus onto another person by as much as 96 percent. Approximately 1.2 million Americans are currently infected with HIV, according to the Centers for Disease Control and Prevention, with one-fifth unaware of their HIV status.

Because of the large stigma that has surrounded HIV and AIDS during the 30 years of the epidemic, privacy during testing has often been a concern. Previous at-home kits, though, involved pricking the finger and mailing a sample to a lab for testing.

The OraQuick In-Home HIV Test, manufactured by OraSure Technologies, Inc., addresses both the privacy and speed issues. The kits are expected to be available over-the-counter in the U.S. by October.

This HIV test is not meant to replace regular medical testing, but to provide another option for consumers to check their HIV status. Individuals who test positive for HIV should still follow up with a doctor for confirmation.

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