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FDA approves home-based rapid HIV test for the first time
Medical expert of the article
Last reviewed: 01.07.2025
One of the most serious challenges in combating the spread of HIV/AIDS is convincing people to get tested for HIV on a regular basis.
Unfortunately, getting someone to go to a hospital is not easy or straightforward, especially in rural areas where there are few alternatives for discrete testing. To address privacy concerns, the U.S. Food and Drug Administration (FDA) has unanimously approved a rapid HIV test that will allow many people to test themselves at home and get results in as little as 20 minutes.
The company that created the test, OraSure, has been distributing the OraQuick rapid HIV test to doctors and medical facilities since 2004. The FDA says the HIV test is easy to use, like a pregnancy test. HIV tests have been available at home before, but they had to be mailed to labs and then wait several days for results.
The FDA says the OraQuick test will reach a much wider range of potential buyers and give people an immediate way to know if they are HIV-positive. Government officials estimate that nearly 240,000 people in the U.S. alone are unaware that they are infected, and the test is a huge and significant step toward curbing the spread of HIV/AIDS.
Recall that recent studies conducted by OraSure found that the rapid test was only 93% accurate, while the required 99% was. After discussions, the FDA panel decided that the benefits of the test far outweighed this drawback. The FDA panel also emphasized the importance of the rapid test packaging clearly stating that a negative result does not necessarily mean that a person does not have HIV.
OraSure did not say what the price of the OraQuick test will be once it hits drugstore shelves. The professional version of the OraQuick HIV test currently sells for $17.50.