BREAKING: FDA Approves OraQuick Rapid Home HIV-Testing Kit

The OraQuick In-Home HIV Test, the nation’s first over-the-counter and self-administered HIV test kit, has just received approval from the FDA.

OraQuick’s test, the first home kit that detects antibodies for both HIV-1 and HIV-2, enables users to get their results by swabbing their gums and placing the sample in a provided vial. The results are said to be ready in 20 to 40 minutes. While OraQuick will have a consumer-support hotline available 24/7, the company is quick to state that a positive result should be followed by additional testing in a clinic or doctor’s office.

“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.”

While OraQuick may shrink the number of HIV+ people who are unaware of their status (currently 20% of the infected population), it could also give a false sense of security to people exposed in the past three months, before the virus would register on a test. Additionally, clinical studies showed the OraQuick In-Home HIV Test has a 92% accuracy rating, meaning that on average one false negative result would be expected out of every 12 test taken by HIV+ individuals. (False positives are rarer, with one false positive expected out of every 5,000 test taken by HIV- people.)

Bottom line, OraQuick can be a helpful tool in the fight against AIDS but it shouldn’t replace safer sex and regular testing at facilities staffed by trained professionals.

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