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FDA News
Approval of first In-Home HIV antibody Test

<p>Richard Klein and Kimberly Struble</p>


July 3, 2012

On July 3, 2011, 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 obtain test results within 20 to 40 minutes using an oral fluid 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 large numbers of 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 provides 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 would 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.

While the newly approved test is the first home use kit that provides rapid results to the user, there is another FDA-approved home test collection kit, the The Home Access® HIV-1 Test System, approved since 1996. The Home Access HIV-1 home collection test system is sold as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System." It allows blood samples to be taken at home using a simple finger stick, that people then send to a laboratory for testing, which includes both screening and confirmation. Results are obtained by phone using an individual identifier code supplied with the product. The sensitivity determined in clinical studies reported is estimated to be 100% based on the correct identification of 150/150 positive samples compared to matched serum specimens. The specificity determined in the studies reported is estimated to be 100% based on the correct identification of (997/997) negative samples compared to matched serum specimens.

For more information:
Consumer Update
Questions and Answers

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration



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