Approval of first In-Home rapid HIV antibody test kit

On July 3, 2012, FDA approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2.

The OraQuick In-Home HIV Test is designed to allow individuals to obtain test results within 20 to 40 minutes using an oralfluid sample collected by swabbing the upper and lower gums inside the mouth, then placing that sample into a developer vial provided as part of the kit.

A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result.

Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.

Not all individuals develop antibodies to HIV at the same rate, and so it make take longer for some to develop levels of antibodies detectable using an antibody test.  This time to detectable antibody levels is called "the window period."

The test has the potential to identify previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.

Because knowing your status is an important factor in the effort to prevent the spread of HIV, the availability of a home-use HIV test kit is useful as another option for individuals to get tested so that they can seek medical care.

Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92% for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result could be expected out of every 12 test results in HIV-infected individuals.

Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98% for test specificity, the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals.

OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test will have a telephone consumer support center available 24 hours a day, seven days a week once the product is available for sale to the public. The center will provide education about HIV/AIDS, the proper method for administering the test, and guidance on what to do once results have been obtained. Information about the consumer support center and contact information is included in the test kit.

OraSure Technologies, Inc. is headquartered in Bethlehem, Pa. A version of this test for use by trained technicians in clinical settings was approved in 2004.

For more information:

• FDA Consumer Update: First Rapid Home-Use HIV Kit Approved for Self-Testing 
• OraQuick Rapid HIV-1 Antibody Test Questions and Answers
• At-Home Rapid HIV Testing: An Interview With FDA , An Expert Interview With FDA's Elliot Cowan

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration