First home-use HIV test to be released in the US

The first over-the-counter HIV test has been approved by the US Food and Drug Administration. Expected to go on sale within the next few months, the test will allow Americans to test themselves for the aids-causing virus in the privacy of their homes.

Confirmed to retail for less that $60 (£38), the OraQuick test detects the presence of HIV in saliva from a mouth swab, and returns a result within 20 to 40 minutes.

With the marketing focusing on those at greater risk of being infected, FDA officials are trying to reach out to people who might not get tested otherwise. The US government estimates that about one fifth of the 1.2 million HIV carriers in the United States do not know that they are infected, and with the rate of new infections remaining steady at 50,000 a year for the past two decades, home testing could be a vital tool in slowing the virus. HIV eventually develops into AIDS unless it is treated with antiviral drugs, and although there is no cure for AIDS, the antivirals aim to prevent or delay the onset from HIV. AIDS causes the body’s immune system to break down, meaning infections become fatal.

Tom Donohue, founding director of Who’s Positive, a leading HIV awareness group, said: “This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to.”

The FDA has stressed that the test is not 100% accurate however, with trials conducted by Orasure, the manufacturer, concluding that the test could miss one person for every 12 people infected. The test was more accurate in ruling out potential carriers as not having the virus, with a positive result of 99% accuracy. Dr Jonathan Mermin, director of the Centres for Disease Control and Prevention’s HIV unit, emphasised the need to get re-tested if users receive a negative reading, as it can take several weeks for detectable antibodies to appear.

Emily Eastman