Jul 3 2012
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Afternoon Update: FDA Approves First Over-the-Counter Home Use HIV Test Kit

The Food and Drug Administration (FDA) has approved the first in-home HIV Test. The test, called OraQuick, does not require a prescription and can detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Consumers use the test by swabbing the upper and lower gums inside of their mouths, then placing the fluid sample collected in a vial that comes with the kit. Results are available within 20 to 40 minutes. The FDA says a positive result does not mean that an individual is definitely infected with HIV, but that additional testing should be done in a medical setting. And a negative test result does not mean that an individual is definitely not infected with HIV, especially if exposure to the virus was within the past three months.

Clinical studies have found that one false negative result would be expected out of every 12 test results in HIV-infected individuals and one false positive would be expected out of every 5,000 test results in uninfected individuals.

OraSure Technologies, which makes the test, will have a consumer support center open 24/7 to help consumers conduct the test and to make referrals for information on prevention and treatment once the test is completed.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, MD, 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.” According to the FDA, the test will be targeted to people who would not otherwise be tested. “There’s a large group of people who are infected, and don’t know it,” says Midthun. “And even if they are engaged in behaviors that would put them at risk of getting HIV, they may be reluctant to visit their doctor or a health care facility to be tested.”

The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection. 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.

Tags: AIDS, HIV