December 27, 2012 | by Lou Chibbaro Jr.
Year in review: Home HIV tests become available
OraSure, OraQuick, HIV, HIV test, gay news, Washington Blade

(Photo courtesy OraSure Technologies Inc)

The U.S. Food and Drug Administration approved for the first time on July 3 an in-home, self-administered HIV test to be sold over the counter.

Known as the OraQuick In-Home HIV test, the test was developed by OraSure Technologies, Inc.

“The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods,” the FDA said in a new release.

“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. “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 FDA says clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with the kit, one negative result could be expected.

“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 result,” the FDA said. “Similarly, 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.”

FDA officials noted that the OraSure in-home test is the first HIV test that allows users to learn their results at home immediately without interacting with a lab or medical professionals.

The officials said the new test’s potential for identifying large numbers of people who don’t know they are infected outweighs concern by some that people who test positive should have immediate access to counseling and medical advice.

Experts estimate that one-fifth of the people infected with HIV are unaware of their status and often contribute to the infection of others.

Lou Chibbaro Jr. has reported on the LGBT civil rights movement and the LGBT community for more than 30 years, beginning as a freelance writer and later as a staff reporter and currently as Senior News Reporter for the Washington Blade. He has chronicled LGBT-related developments as they have touched on a wide range of social, religious, and governmental institutions, including the White House, Congress, the U.S. Supreme Court, the military, local and national law enforcement agencies and the Catholic Church. Chibbaro has reported on LGBT issues and LGBT participation in local and national elections since 1976. He has covered the AIDS epidemic since it first surfaced in the early 1980s. Follow Lou

1 Comment
  • I’m sure it was an inadvertent (not an ignorant) omission, but omitting the word FALSE in the following sentence was a major editing error:

    The FDA says clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with the kit, one (FALSE) negative result could be expected.

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