fda green lights first over the counter hiv test kit
Being able to test yourself for HIV with a over the counter kit will most likely be a big success.This I am sure will put many minds at ease with being able to test your self.
The U.S. Food and Drug Administration has approved the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to HIV type 1 and type 2. The OraQuick In-Home HIV Test has the potential to identify large numbers of previously undiagnosed HIV infections, says the FDA, especially in those who are unlikely to use standard screening methods.
Individuals wanting to take the home test simply swab their upper and lower gums and place the sample into a developer vial. Results are given within 20 to 40 minutes. A positive result does not guarantee that the person is infected with HIV, but means they should undergo additional testing in a medical setting to confirm the result. In the same way, a negative result does not guarantee that the person is not infected with HIV, particularly when exposure to the virus may have been within the previous three months.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “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.”
The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV, the virus that causes AIDS. Approximately one in five of these are not aware of their HIV status. Of the 50,000 new HIV infections every year, many are transmitted by people who do not know that they are infected.
A version of the OraQuick In-Home HIV Test for use by trained technicians in clinical settings was approved by the FDA in 2004. Results from these clinical studies have shown that the test has a 92 percent chance of giving a positive test result when HIV is present, meaning that they project one false negative result out of every 12 tests of people infected with HIV. Clinical studies have also projected that the test has a 99.98 percent of showing a negative test result when HIV is not present, meaning that one false positive is expected out of every 5,000 tests of people not infected with HIV.
OraSure Technologies is the manufacturer of the in-home test and will have a consumer support center that individuals can reach over the phone 24 hours a day, seven days a week. The center will offer users educational information about HIV/AIDS, the proper method for administering the test and advice on what to do once they have received results from the test.Read more:
Read more: http://www.capitolcolumn.com/news/fda-green-lights-first-over-the-counter-hiv-test-kit/
One question to ask will this make people more care free with unprotected sex? As it will be more easy to get results and become more desensitized from the the heath risks. We shall see as the years float by.