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FDA Approves Home HIV Testing
By Staff on July 4, 2012
Does anyone recall home HIV test, Confide by Johnson and Johnson that was pulled from the store shelves in June 1997 for lack of sales? Well times, HIV/AIDS statistics, and pricing have all changed and so home based HIV testing is baaaack!
The U.S. Food and Drug Administration approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect HIV type-1 and HIV type-2. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
The OraQuick In-Home HIV Test works by having individuals collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. 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. So if you get this outcome at home, you nervously have to get it confirmed at a local clinic or hospital – where likely a blood sample will be taken.
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 (e.g. 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.
The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection. About one in five are not aware they are infected.
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. This is a key issue to keep in mind for those home testing for the first time or testing while in an emotional state. 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 consumer support center that is available via phone and will be open 24 hours a day, seven days a week. Information about the consumer support center and contact information is included in the test kit.