HIV Test: Over-the-Counter Version Approved by the FDA

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An HIV test approved for home use by the FDA is scheduled to become available to the American population this October, according to CBS News. OraQuick, which will be available at Walgreens, CVS, Walmart, and various online pharmacies, should run consumers no more than $60, though health professionals will be able to secure a test for roughly $17.50.

"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," explained Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. Officials also stated the kits were being marketed to those who may not pursue testing through more traditional means.

The OraQuick system detects HIV by collecting saliva on a mouth swab. Once the sample has been taken, users can expect results within 30 to 40 minutes. According to the FDA, the test is not 100% accurate; in trials, the system detected the virus in 92% of those who used it, meaning that it could miss one person for every 12 individuals who use the kit. On the flip side, OraQuick was able to rule out the virus in 99% of tests.

In addition to the test, users will also have access to a call center should they require counseling and medical referrals upon receiving the results. "Each of the call-center operators is bilingual in English and Spanish, they've gone through 160 hours of training on HIV counseling and testing," explained Oracare CEO Doug Michels. "So they are highly trained professionals and they'll be there to support the consumer."

Presently, there are thought to be 1.2 million HIV carriers in the United States alone, one fifth of whom are not aware that they have contracted the virus.

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