First take-home HIV test wins FDA approval

Published: Monday, July 9 2012 2:23 p.m. MDT

This undated handout photo provided by Orasure shows the OraQuick test, which detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes. The U.S. Food and Drug Administration approved the first over-the-counter HIV test Tuesday, July 3, 2012, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes.

Orasure, Chuck Zovko, Associated Press

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The first over-the-counter HIV test was approved by the Food and Drug Administration on Tuesday, enabling Americans to test themselves for the virus in the privacy of their homes.

The OraQuick test collects saliva in a mouth swab. Within 20 to 40 minutes, the test will detect the presence of HIV, USA Today reported. Of the 1.2 million HIV carriers in the U.S., an estimated 240,000 people are unaware that they are infected. There has been a steady 50,000 infections per year for two decades.

"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," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.

OraSure, the product manufacturer, has confirmed that the product would cost less than $60, though they have not said how much the test will sell for, the BBC reported. "The test is expected to be sold in as many as 30,000 pharmacies and department stores, as well as online."

Some objections have surfaced. "When used by average consumers, rather than by health care professionals, the test is accurate 99.98 percent of the time for people who are not infected, but only 92 percent of the time for people who are H.I.V.-positive," the New York Times reported. "That means about one infected person in 12 would get a false negative, but only about 1 in 5,000 uninfected people would get a false positive.

"Any positive test needs confirmation in a doctor’s office, the F.D.A. said. It approved the test not to replace medical testing but because many Americans never get tested at all. The hope is that the home test will encourage infected people to seek medical care earlier, helping save lives and slow the spread of the epidemic."

Rachel Lowry is a reporter intern for the Deseret News.

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