The FDA just published a press release announcing they have approved the first over-the-counter in-home private use HIV testing kit, the OraQuick In-Home HIV Test. This is a big deal, as many, many people are too afraid to go to their doctor and ask for an HIV test.
“The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection,” the FDA notes. “About one in five are not aware they are infected. There are about 50,000 new HIV infections every year. Many of these new infections are transmitted from people who are unaware of their HIV status.”
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”
They also note that the “OraQuick In-Home HIV Test is designed to allow individuals to 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.”
The FDA calls the result “a preliminary (or screening) result,” on their consumer website, which also cautions the test is “not reliable at detecting HIV infection until at least three months after infection,” and that a negative result does not definitely mean the user is HIV-negative, noting, “even after three months, there can also be false negatives. Clinical studies by untrained consumers showed that the OraQuick test will produce about one false negative result out of every 12 tests performed in HIV infected individuals.”
Still, it’s a good start.
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