FDA Approves First At-Home Quick HIV Test

The over-the-counter OraQuick test may appeal to those who want convenience and privacy.

The OraQuick In-Home HIV Test allows users to test for the HIV virus in the privacy of their own homes. (Photo: Courtesy of OraSure Technologies)

Jul 3, 2012
Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal and got in a boxing ring.

The Food and Drug Administration approved the first over-the-counter HIV test kit designed for home use today, making the testing process easier and more private.

The OraQuick In-Home HIV Test gives results in 20 to 40 minutes after swabbing the mouth and placing the sample into a developer vial. The FDA notes that a positive or negative result warrant further tests. Those who test positive should see their doctors, and those who test negative may not be out of the woods, especially if they were exposed within the past three months.

In clinical studies the kit proved fairly precise. It was about 92 percent accurate in correctly recognizing those who were HIV positive, which translates into one false negative result out every 12 tests.The test was about 99 percent accurate in correctly identifying those who were HIV negative, meaning one false positive would be anticipated in 5,000 test results.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”

About 1.2 million people in the U.S. have the HIV infection, the Centers for Disease Control and Prevention says, and about one in five don’t know they’re infected.

OraSure Technologies, the Pennsylvania-based company making the tests, says it will have a consumer support center available 24 hours a day, seven days a week, to answer questions about the test and to offer guidance on how to use it. The tests are due to be released in October.

CBS News reports that the FDA has already approved several at-home HIV tests, but they require a blood sample and must be sent to a lab for results.

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