IMAGINE if testing for HIV was as simple as a pregnancy stick test. A quick swab of your gums, and 20 minutes later a thin red line on the device could be the difference between a healthy life and coping with a deadly disease.
The test, called OraQuick Advance and made by OraSure Technology of Bethlehem, Pennsylvania, is already being used in clinics in the US. Last week the US Food and Drug Administration (FDA) started debating whether the kit should be available for people to test for HIV in their own homes, potentially drawing out the estimated 300,000 or more Americans who live with the infection but don’t know about it. These people are the cause of 65 per cent of all new HIV infections in the US each year. People who know they are infected are 50 per cent less likely to transmit HIV than those who do not.
At the heart of the debate is the question of what happens when someone tests positive at home. Without the counselling they could get in clinics, would people be more likely to get depressed or even attempt suicide? Studies have shown that people with HIV are 36 times more likely to commit suicide than people in the general population.
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“What happens when someone tests positive at home? Without counselling they might be more likely to attempt suicide”
Opinions at the FDA debate were divided. For instance, a representative from the American Society for Microbiology insisted that exposing patients to such risks is “entirely irresponsible”. But Freya Spielberg of the University of Washington Center for AIDS Research in Seattle argued in favour of the home test and pointed out that women are not discouraged from doing home breast exams just because finding a lump might make them nervous.
The FDA also discussed whether people can accurately use OraQuick by themselves. The device detects antibodies produced in response to HIV. The person has to swab their upper and lower gum lines with a collector device that resembles a pregnancy test stick and then insert the absorbent end into a special solution for 20 minutes. When used in clinics, the device accurately detects antibodies 99.3 per cent of the time. Initial trials carried out by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, suggest that members of the public can use OraQuick successfully, though further trials will be required for FDA approval.
If approved, the test could encourage the development of similar at-home tests for diseases such as syphilis, hepatitis C and influenza. Douglas Michels, OraSure’s chief executive officer, says the company is already working on a rapid home test for hepatitis C.
But Bernard Branson of the CDC cautions that tests for other diseases will take time, and notes that the FDA has already rejected proposals for over-the-counter tests for syphilis and influenza. “I think you wouldn’t see these until years from now, because the tests aren’t yet up to the same standards [of accuracy] as we have with HIV,” he says. “But I think resolving a lot of the social and practical issues that are so poignant with the [HIV] test would definitely draw some attention.”
