HIV test kit that will cut infection rate on course for US market

American consumers may soon be able to test themselves for the virus that causes Aids in the privacy of their own homes, after a panel of experts recommended approval of the first rapid, over-the-counter HIV test.

The 17 members of the federal Food and Drug Administration (FDA) advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panellists said it could provide an important way to expand HIV testing.

The FDA will make its final decision on whether to approve the product later this year.

Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the US are not aware they are infected. Testing is one of the chief means of slowing new infections.

Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 per cent of the time.

But a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 per cent of the time. The FDA estimated the home test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000.

The test could prevent 4,000 new transmissions of the virus annually, though the figure could vary depending on how many people purchase the test.

Panellists stressed that the test’s labelling should state that a negative reading does not automatically mean the person does not have HIV and said an emergency helpline telephone number should be attached to the test.

“Over-the-counter testing has the potential to reach a far greater number of people who want to know their HIV status on their own terms,” said Tom Donohue, founder of the HIV awareness group Who’s Positive.

“We are always looking for game changers, and we believe this is one of them,” said Carl Schmid, deputy director of the AIDS Institute. “Not only will it help reduce the number of infections but it will bring more people into care and treatment.”

The FDA has already approved other HIV test kits designed to be used at home, although those kits require a blood sample which must be sent to a laboratory for development.

FDA officials said the test would be most effective in the hands of people at high risk of acquiring the virus.

A recent survey of gay and bisexual men in the US found that 84 per cent would test themselves more frequently if they could buy an over-the-counter HIV test.