AMERICANS COULD soon be testing themselves for HIV in the privacy of their own homes after a new testing system was approved by the US Food and Drug Administration.
A simple mouth swab is checked by the OraQuick test to detect the presence of HIV antibodies, and takes up to 40 minutes to generate a result. The test will be made available over the counter.
FDA officials say that a positive result does not mean that the person is definitely infected with HIV and additional testing should be carried out “in a medical setting” to confirm the result.
They also note that a negative result does not mean that the person is definitely not infected, particularly when they may have been exposed to HIV in the three months before taking the home test.
However, the FDA noted that “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 test is produced by the Pennsylvania-based OraSure Technologies. According to the FDA statement on the test:
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.Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98 percent 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.
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