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. Last Updated: 07/27/2016

Home Test For HIV Approved

WASHINGTON -- Americans worried that they may have HIV, the virus that causes AIDS, will soon be able to test themselves and find out the answer confidentially, from the privacy of their own homes.


The Food and Drug Administration on Tuesday approved the first testing kit for HIV that allows users to collect their blood samples at home. The Confide HIV Testing Service was developed by a Johnson and Johnson subsidiary, Direct Access Diagnostics, and includes a telephone counseling and referral service.


"Too many Americans do not know their HIV status," said Donna Shalala, secretary of Health and Human Services, in a statement announcing the approval. "Knowledge is power, and power leads to prevention."


The idea of home testing for AIDS has long been controversial, but over time many of the groups that originally opposed it have come around to supporting the product in order to give more people access to health information. But clinics that provide AIDS counseling services say the telephone counseling service is inadequate for learning such dire news.


Proponents of the test kit point out that only 14 percent of people voluntarily tested for HIV received any counseling afterward, according to figures collected by the Centers for Disease Control and Prevention. The CDC estimates that more than 60 percent of Americans at risk for HIV have not been tested.


The company will initially sell the $40 kits in pharmacies, college health centers and public health clinics in Texas, or via toll-free numbers in Texas and Florida. The kit should be available nationally by 1997, said Direct Access vice president Gary Noble, but the company decided to limit its marketing at first to ensure that the service worked as expected.