An over-the-counter rapid HIV test has been approved by the US Food and Drug Administration.
The first of its kind test, called the OraQuick In-Home HIV Test, allows users to swab their upper and lower gums with the included test pad device and place it into a vial of solution which can detect antibodies to both HIV-1 and HIV-2.
Similar to home pregnancy tests, one line will show up if the test is negative, two lines means a positive test. Test results take about 20 minutes.
A positive reading does not mean a definite HIV infection, users are instead encouraged to seek additional testing with a health professional.
The FDA also cautioned that 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”.
Another in-home test was approved by the FDA in 1996, but it involved sending samples away for lab results.
Clinical studies for self-testing have shown that the in-home HIV test has an expected performance of 92 percent when HIV is present, which means that one false negative result would be expected out of every 12 test results in HIV-infected individuals.
Alternatively, it has a 99.98 percent test specificity when HIV is not present, meaning one false positive would be expected out of every 5,000 test results in uninfected individuals.
“Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing,”OraSure Technologies CEO and president Douglas A. Michels said in a statement.
“For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed.
“This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting.”