FDA Approves First OTC Home Use HIV Test

The FDA today approved OraQuick In-Home HIV Test, the first over-the-counter HIV test that gives users results without having to send samples off to a lab.

The FDA today approved OraQuick In-Home HIV Test, the first over-the-counter HIV test that gives users results without having to send samples off to a lab.

Now Americans can test themselves for HIV in the privacy of their own homes, thanks to the OraQuick In-Home HIV Test, which was approved today by the FDA.

The kit tests for the presence of antibodies to HIV-1 and HIV-2. Individuals collect a sample by swabbing the inside of their upper and lower gums and placing the swab into a developer vial for results within 20 to 40 minutes.

Although the at-home test has the potential to identify a large number of previously undiagnosed HIV infections, the test is not 100% accurate. Clinical studies have shown that the test “has an expected performance of 92% for test sensitivity”—in other words, one false negative result would be expected out of every 12 test results in HIV-infected individuals.

In individuals who are HIV-free, the test has an expected performance of nearly 100%, or 99.98%. This means that the test would incorrectly identify one patient as having HIV for every 5000 HIV-negative individuals tested.

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

This is the first at-home test of its kind; previously approved OTC HIV tests involved blood samples and had to be sent out to a lab for results.