The US Food and Drug Administration (FDA) announced on Tuesday that is has approved the first over the counter HIV test kit that allows Americans to test, in the privacy of their own homes, whether they are infected with the virus that causes AIDS.

The OraQuick In-Home HIV Test detects the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).

It is the first rapid diagnostic test for any infectious disease that the FDA has approved for sale over the counter.

The kit, from OraSure Technologies of Bethlehem, Pennsylvania, is an over the counter version of a test used by trained technicians in clinical settings that the FDA approved in 2004.

The user takes an oral swab, and places it in a specially prepared vial that comes with the kit. The result is ready in 20 to 40 minutes.

The kit is not as reliable as getting tested by a trained clinician.

A positive result does not necessarily mean that the user is definitely infected with HIV, but that they should then go and get themselves tested in a medical setting to confirm the result.

Similarly, a negative result does not necessarily mean the user is definitely not infected: particularly if they may have picked up the virus in the previous three months.

Based on clinical studies, the kit is expected to show one false positive out of every 50,000 results and one false negative out of every 12 results.

The idea is not for the home test kit to replace medical testing, but to provide another route for people to find out their HIV status.

Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, told the press:

“Knowing your status is an important factor in the effort to prevent the spread of HIV.”

“The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate,” she added.

The federal agency says the test has the potential to identify large numbers of undiagnosed HIV infections, especially if those who use it are people unlikely to have used any standard screening.

According to the US Centers for Disease Control and Prevention (CDC), there are around 50,000 new HIV infections in the US every year, many of which are caused by people who do not realize they carry the virus.

An estimated 1.2 million Americans are living with HIV, says the CDC, of which around 1 in 5 are not aware of it.

OraSure Technologies are setting up a toll-free telephone-based consumer support center that will be open 24 hours a day, seven days a week from Monday 9 July. The number to contact will be included in the kit.

Users contacting the center can find out about HIV/AIDS, how to use the test, and what to do when they have the result: they can also get a direct referral to care, if needed.

The company says that from October, when they start selling the kit through more than 30,000 retail outlets throughout the country and online, there will also be a website providing access to further resources and referral to follow-up counselling and medical care.

Douglas A Michels, President and CEO of OraSure Technologies described the FDA approval as a “major breakthrough in HIV testing“:

“This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting.”

Written by Catharine Paddock PhD