Health & WellnessNews

FDA Approves First Over-The-Counter Home Use HIV Test Kit

by Megan Smith

The latest in HIV testing has arrived. OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit, received U.S. Food and Drug Administration approval July 3.

With a simple swab of the upper and lower gums, individuals can place their sample into a developer vial, and receive results in 20 to 40 minutes. The test is designed to detect the presence of antibodies to human immunodeficiency virus type 1 and type 2.

If positive results do occur, the test is not a guarantee that the individual is definitely infected, but rather that further testing should be done in a medical setting. Although the test has a high level of accuracy, about one in twelve tests can display a false negative, especially if exposure to the virus occurred in the last three months. One out of 5,000 tests display a false positive.

An estimated 1.2 million people in the U.S. are currently living with the HIV infection, according to the Centers for Disease Control and Prevention. With one out of five individuals unaware of their positive status, there are about 50,000 additional cases diagnosed each year. The OraQuick In-Home HIV test provides a more comfortable alternative to traditional HIV testing, presenting the opportunity to identify large numbers of previously undiagnosed HIV infections.

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

A customer support center for OraSure Technologies, the manufacturer of the in-home HIV test, will be available by phone 24 hours a day, seven days a week to answer any questions about the product, provide information on HIV and AIDS, and give guidance on test results.


Megan Smith

Megan Smith is the Assistant Editor for OutSmart Magazine.

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