New Rapid Home-Use HIV Kit Approved for Self-Testing

The FDA approved the OraQuick In-Home HIV Test, a rapid home-use HIV test kit that does not require sending a sample to a laboratory for analysis. The kit provides a test result in 20-40 minutes, and consumers can test in their own homes. The kit, which tests a sample of fluid from the consumer’s mouth, is approved for sale in stores and online to anyone age 17 and older.


The FDA wants consumers to know that positive test results using the OraQuick test must be confirmed by follow-up laboratory-based testing. Also, the test can be falsely negative for reasons that include the occurrence of HIV infection within three months before testing. People who engage in behaviors that put them at increased risk of getting HIV—including having unprotected sex with new partners, or injecting illegal drugs—should be re-tested on a regular basis. They should not interpret a negative test to indicate that engaging in high risk behavior is safe.


According to the CDC, about 1.2 million people in the U.S. are living with HIV infection, and about 20% of these people do not know that they are infected, increasing the chance that they will unknowingly spread the infection.


Paul A. Mied, Ph.D., deputy director of the FDA's Division of Emerging and Transfusion Transmitted Diseases, describes the potential impact of this test and the messages that the FDA wants to send consumers. “This test is targeted to people who would not otherwise be tested. There's a large group of people who are infected, and don't know it. And even if they are engaged in behaviors that would put them at risk of getting HIV, they may be reluctant to visit their doctor or a health care facility to be tested.”


The FDA predicts that the availability of the OraQuick In-Home HIV test will contribute measurably to public health by helping more infected individuals to become aware of their HIV status and thereby reducing HIV transmission.


Since 2002, the FDA has approved a number of rapid HIV tests (tests that require no special equipment and provide results in as little as 20 minutes) that can be used by trained individuals outside of a traditional laboratory or clinic. The OraQuick In-Home HIV Test provides another testing option for people to learn their HIV status.


Additionally, in 2013, the FDA approved the first rapid HIV test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2. Detection of the antigen permits earlier detection of the HIV-1 infection than is possible by just testing for antibodies. HIV-1 is responsible for most HIV infections. HIV-2 is found primarily in West Africa, although cases have been reported in North America and Europe.


The newly approved test works by checking for antibodies to HIV. The consumer swabs the upper and lower gums for an oral fluid sample with the test device. That device is placed in a tube with a developing solution. After 20 to 40 minutes, one line will appear if the test is negative. Two lines indicate that HIV antibodies were detected and that the consumer may be HIV positive. A positive test means that further testing is needed to confirm the consumer’s HIV status. This is a first step in HIV testing. No test is perfect—there will be false positives. Clinical studies for self-testing have shown that the OraQuick test will produce one false positive result out of about every 5,000 tests in uninfected individuals.


A negative test does not mean that the tester definitely doesn't have HIV. This is important for users of the test to understand. The test is not reliable at detecting HIV infection until at least three months after infection. In addition, even after three months, there also can be false negatives. Clinical studies by untrained consumers showed that the OraQuick test will produce about one false negative result out of every 12 tests performed in HIV infected individuals.


See the FDA Consumer Update



See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks