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March 22, 1995

Home Testing Kits for HIV Apt to Get FDA Approval

JAMA. 1995;273(12):908-909. doi:10.1001/jama.1995.03520360020008

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HOME TESTING KITS for spotting the AIDS agent are moving closer to approval. The Food and Drug Administration (FDA) has had a change of heart about approving these kits for detecting the presence of the human immunodeficiency virus (HIV).

The agency's move reverses its earlier position, when it held that these kits could be used only under the supervision of a physician or other qualified health professional. The FDA now says that it would approve the kits for over-the-counter use as long as those with a positive test result are referred for counseling and postmarketing studies are put in place to assess the public health impact.

This decision has once again fired up discussion of the value of home test kits for detecting HIV. Faced with the virtual certainty that the FDA will approve HIV test kits, the group Gays and Lesbians for Individual Liberty held a forum in Washington,

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