This first-ever, in-home HIV screening test will give individuals results in 20 minutes at home
In May 2012, an advisory panel for the Food & Drug Administration (FDA) recommended 17 to 0 to approve the OraQuick In-Home HIV Test. The test is a repackaging of the same antibody test used by health care professionals. It can detect both HIV-1 and HIV-2.
To use it, individuals will swab their upper and lower gums to collect oral fluid and then place the swab in a solution. After 20 minutes, one of two marks appears: one visible line means the test is negative while two lines mean it is positive. All positive results need to be confirmed by a blood test done by a medical professional.
As for the test’s sensitivity, or ability to find every person who is truly HIV-positive, clinical study results were 93 percent accurate. The FDA’s lowest limit for this type of test is 95 percent, but the panel recommended the test despite this 2 percent lower rate of accuracy. In contrast, when the test is done by medical professionals, its sensitivity is more than 99 percent.
As for its specificity, or its ability to exclude every person who is truly HIV-negative, the test is more than 99% accurate when done by people in their homes. This rate of accuracy is similar to medical professionals.
One panelist also noted that there are similar false-result rates seen with home pregnancy tests.
Although most panelists remarked that the home test provides a significant new way to expand testing and detect more infections in the US, others also expressed concerns. First was concerning the false-result rate, which could cause some people to be unaware of their true HIV status. Second was a concern that some people who test positive at home may be unable to overcome the shock of their result, causing them not to access services they need both to confirm the result or begin a discussion about long-term medical care and treatment. And third, a negative test result is only as good as the window period before it, or those two to three months that it can take for HIV to create enough antibodies to cause a positive result. For those who were infected just two weeks before taking the test, the negative result is inaccurate. This may enable some to engage in riskier behavior when in fact they should be taking more precautions.
The FDA believes this home test could identify up to 45,000 new diagnoses and could prevent nearly 4,000 new infections each year. Currently, more than 50,000 new infections occur in the US every year, and about 240,000 Americans do not know they have HIV. While acknowledging the concerns above, Project Inform agrees that the benefits of the rapid home test –  especially the likelihood that a significant percentage of undiagnosed people with HIV will feel more comfortable testing at home than visiting a provider – outweigh the risks.
OraSure, the company that makes OraQuick, says it will provide ample instructions on how to accurately use the test, interpret the results and access support services, along with a 24-hour support line. The over-the-counter cost of OraQuick is unknown at this time but is likely to cost less than $60. It will be available in drugstores and probably online.
The FDA will officially decide on whether to approve the home HIV test later in the year.