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FDA Approves At-Home HIV Test

HIV Rapid Test Kit -- Orasure

This week, the U.S. Food and Drug Administration finally approved a rapid, over-the-counter, and at-home test for HIV. The test, called OraQuick and made by OraSure, allows people to check their serostatus in the convenience and privacy of their own homes and illustrates the change in perception around HIV ever since it became an epidemic over thirty years ago. Although people could take an at-home test that requires a blood sample to be mailed to a testing center, the OraQuick test takes 20-40 minutes, needs only a mouth swab, and costs about $35 online.

As The New York Times reports, it has been a long and rocky road for the approval of an at-home HIV test in the United States. The first application for approval for an at-home test came (and was denied) in 1987, and the FDA has been deliberating on OraQuick for six years. As HIV has become a more manageable, chronic condition and stigma around HIV has lessened (though certainly not abated), and the climate has become more appropriate for quick, reliable testing.

There is still much caution in the HIV prevention and treatment field around testing–for example, a rigorous pre-test counseling process at a health clinic in South Africa, the test, and a follow-up counseling session. As the Times recounts, in the past (and today, in certain settings), many feared a surge of suicides following a positive result from at-home tests where patients could not receive the necessary counseling and support. Similarly, an unreliable test could encourage people who receive negative results but are HIV-positive to continue risky behaviors, passing on the virus. There’s also often a latent period between the time of infection and its ability to be seen on a test, which is usually no longer than three months. During this time, a person can still infect someone else.

As per Reuters, the OraQuick is 92 percent effective in determining positive results–meaning that one in 12 people with HIV will get a false negative. It is 99 percent accurate in determining a negative result. Although the accuracy is not perfect and any positive result should be followed up with testing and guidance in a medical facility (as one would with a positive pregnancy test, for example), it’s a step forward in decreasing the number of new infections in the U.S., where there are about 50,000 new cases a year and 1.2 million people living with HIV. Of those people, around one in five do not know their status (AVERT). Dr. Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, told NPR that 50 to 70 percent of new infections in the United States are caused by people who do not know they have HIV.

In brief, the FDA approval is good news. An at-home rapid test is not the panacea that will end the HIV epidemic. Short of a vaccine or a cure, we’re a ways off from that. However, we must make the steps that we can to prevent transmission and allow people to know their status and get further treatment. These small victories will roll back the epidemic–in fact, they already have.

Header photo by Wheeler Cowperthwaite, via Flickr, CC BY 2.0.




Julia Robinson

Julia Robinson has worked in South Africa at an NGO that helps to prevent mother-to-child transmission of HIV and in Sierra Leone for an organization that provides surgeries, medical care, and support to women suffering from obstetric fistula. She is interested in human rights, global health, social justice, and innovative, unconventional solutions to global issues. Julia lives in San Francisco, where she works for a sustainability and corporate social responsibility non-profit. She has a BA in African History from Columbia University.