The U.S. Food and Drug Administration (FDA) may soon approve the first over-the-counter at home HIV test that delivers results within 20 minutes. On Tuesday, May 16 2012, an FDA advisory committee voted unanimously to endorse the test, stating that the benefits greatly outweigh any possible risks. 

OraSure Technologies, Inc. developed the rapid OraQuick test back in 2004 for health care professionals. If the test is expanded to consumers, the FDA estimates that an additional 45,000 HIV-positive individuals will be identified every year.

Although OraSure has not released the price of the rapid test, it will likely cost more than the $17.50 professional version, yet substantially less than $60, according to Stephen R. Lee, OraSure’s executive vice president and chief science officer. The test includes a detailed instructional booklet, and OraSure will establish a call center staffed with trained counselors, available 24 hours a day, seven days a week, for anyone needing guidance after receiving his/her test results.

How does it work?

Patients collect a sample of their oral fluid by swabbing between the teeth and upper and lower gums. The swab is then inserted into a vial of test fluid. The test detects anti-HIV antibodies, which are produced by the body to fight HIV infection. However, these antibodies usually only develop two to three months after infection, and therefore the test might not identify any infections acquired during that time period. Regardless, any results, both positive and negative, are considered preliminary and should be confirmed by a blood test.


Out of 5,558 individuals who participated in a clinical trial of the OraQuick test, 106 previously undiagnosed patients tested positive for HIV and 96% of them said they were highly likely to follow up with a physician for treatment options. Furthermore, nearly 100 percent of HIV-negative and 93 percent of HIV-positive individuals were accurately diagnosed.

In an FDA review it is estimated that the test will reach 2.8 million users every year. Parallel to the statistics revealed by the clinical trial, the review estimates that per year, the test will deliver approximately 1,100 false positive results, and more importantly 3,800 false negative results. This means that 3,800 HIV-positive individuals will receive a negative test result and may not seek follow-up consultation with a physician or counselor. Nevertheless, Susan Buchbinder, an FDA panel member, notes that a positive test result will reduce people’s HIV risk behavior. The vast increase in the number of people who will learn their HIV status will avert more than 4,000 transmissions per year.

Considering that currently about 1.2 million Americans are infected with HIV, yet 240,000 are unaware of their status, this over-the-counter test could have a significant effect on the overall HIV burden in the United States. Routine testing is one of the most effective means to reduce the incidence of new infections, which stands at approximately 50,000 per year in the U.S. 

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