On July 3, the U.S. Food and Drug Administration approved the OraQuick In-Home HIV Test. This will be the first over-the-counter, self administered test kit to be available to consumers.
The test was developed by OraSure Technologies, Inc. and it is capable of detecting the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2), which is the virus that causes acquired immune deficiency syndrome (AIDS).
With the OraQuick In-Home HIV Test, an oral fluid sample can be collected by swabbing the upper and lower gums inside the mouth, then by placing that sample into a developer vial, test results are available within 20 to 40 minutes.
OraSure Technologies reports that the test will be available for purchase in October at more than 30,000 retailers and online. The company explained that a price has not been set and will be determined closer to the launch date, but that the retail price will more than likely be slightly higher than the professional’s rate, which is $17.50.
According to the FDA, clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92 percent 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.
The FDA further cautions that a positive result from an OraQuick test does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result.