OraQuick home HIV test is expected to go on sale in the US within months, after winning regulator approval.
The OraQuick test checks saliva from a mouth swab for HIV and can produce results in 20 to 40 minutes.
Government estimates suggest 1.2 million people in the US are HIV-positive, but 20% do not know they are.
The Food and Drug Administration (FDA) has said it hopes the over-the-counter test will reach people who might not otherwise get tested.
OraQuick home HIV test is expected to go on sale in the US within months, after winning regulator approval
The test is expected to be sold in as many as 30,000 pharmacies and homeware shops, as well as online.
The manufacturer, OraSure, has not said how much the test will sell for but confirmed it would cost less than $60.
“We expect all the major retail outlets to carry this product,” chief executive Douglas Michels said.
The company is planning a “pretty massive effort” to market the test, Douglas Michels added.
Approval of the test has been praised by HIV/AIDS awareness groups.
“This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to,” Tom Donohue, founding director of Who’s Positive, told the Associated Press.
But the FDA has highlighted in its announcement that the test may not be 100% accurate, and has stressed the need for additional testing by medical professionals to confirm the result.
OraSure said that in trials the test was able to correctly detect HIV among people carrying the virus only 92% of the time.
It was 99% accurate for negative results – or identifying that someone does not carrying the virus.
Meanwhile, Dr Jonathan Mermin, director of the HIV unit at the Centers for Disease Control and Prevention, said people who receive negative results should take the test again after three months, because it can take weeks before antibodies to HIV appear.
Healthcare professionals have been using a version of the OraQuick test since 2002.
For the last two decades there have been about 50,000 new cases of HIV in the US each year.
A US panel of experts has backed the over-the-counter HIV tests that would allow people to check in the privacy of their homes if they have the virus.
Experts said the OraQuick In-Home HIV Test was safe and effective and its potential to prevent infections outweighed the risk of false results.
The Food and Drug Administration (FDA) will decide this year whether to approve it.
The 20-minute test is 93% accurate for positive results and 99.8% for negative, the manufacturer said.
HIV affects nearly 1.2 million people in the US, with 50,000 new cases each year.
Experts said the OraQuick In-Home HIV Test was safe and effective and its potential to prevent infections outweighed the risk of false results
Experts on the Blood Products Advisory Committee voted 17-0 to back the test, saying it would help people who are HIV-positive get access to healthcare and social services.
They urged Pennsylvania-based OraSure, the company that manufactures the product, to include highly visible warnings about false negative results.
The panel also advised that the packaging should carry a toll-free phone number offering counseling to those testing positive.
Carl Schmid, deputy director of the AIDS Institute, welcomed the panel’s approval on Tuesday of the home test.
“We are always looking for game changers, and we believe this is one of them,” Carl Schmid told the Associated Press.
“Not only will it help reduce the number of infections but it will bring more people into care and treatment.”
FDA does not have to follow the recommendations of the advisory panel, though it usually does.
In 2004, the FDA approved a 99%-effective version of the test for use by healthcare professionals.
OraSure said the home test could retail for less than $60 if approved.
To take the test, the user swabs the outer gum area so the oral fluid, which is not the same as saliva, can be checked for the HIV virus.
The test provides results within about 20 minutes, but experts say the results should be confirmed with a blood test, which is more accurate.
Last week, a separate FDA panel approved a drug called Truvada, which could become the first drug in tablet form to protect healthy people from the HIV virus.
