
U.S. health regulators approved OraSure Technologies Inc’s in-home test for HIV. The Test uses an oral swab and gives results in 20 to 40 minutes.’OraQuick HIV test’ is expected to be on shelves at more than 30,000 retail outlets, including Walgreens, CVS and Walmart, in early October.
CNN reports:
The first ever over-the-counter rapid HIV test has been approved by the Food and Drug Administration.
Users of the OraQuick In-Home HIV Test swab their upper and lower gums with the included test pad device and place it into a vial of solution. Much like a pregnancy test, one line shows 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 human immunodeficiency virus, but that additional testing should be scheduled with a health professional. However, the FDA also cautions 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.”
The FDA approved another in-home test in 1996, however those samples needed to sent away to a lab for results.
According to the Centers for Disease Control and Prevention about 1.2 million people in the United States are currently living with HIV, but about one in five don’t know they’re infected.
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