FDA Poised To Approve Home HIV Test

An FDA committee today gave preliminary approval to what would be the nation’s first-ever in-home HIV test. The OraQuick rapid HIV test is already in use at many health clinics. Previous over-the-counter home HIV testing kits required sending a blood sample to a laboratory. The National Minority AIDS Council responds via press release:

“Approximately 50,000 individuals in the U.S. are newly infected with HIV each year,” said National Minority AIDS Council Director of Legislative and Public Affairs Kali Lindsey. “Even more alarming is the fact that one in five people living with HIV in America do not know it. The OraQuick In-Home HIV Test would provide an important tool to supplement current HIV screening efforts by providing an accessible, relatively inexpensive device that can be used in the privacy of one’s own home. This is especially important for minority communities, where HIV stigma often prevents individuals from utilizing traditional testing services.”

Some HIV/AIDS groups have warned that at-home HIV tests could result in self-harming actions when the result is positive. Others have expressed concerns about the potential for forced testing of teenagers by anti-gay parents.

UPDATE: Poz.com has more on the story.

Only one OTC HIV testing kit has been approved by the FDA. The Home Access HIV test, approved in 1996, requires blood samples to be collected at home, followed by shipment to a laboratory for analysis—results are provided by a Home Access telephone operator. The retail price is between $30 and $40. The OraQuick In-Home HIV Test allows users to collect samples, conduct the test and interpret the results on their own. The test result is read after 20 minutes, but not longer than 40 minutes, after inserting the oral swab device into the vial of developer solution provided with the OTC kit. The retail price of the test is not yet known.