The U.S. Food and Drug Administration on Tuesday approved the latest over-the-counter HIV test, allowing Americans to get preliminary results on their status in as little as 20 minutes without drawing blood.
Dubbed OraQuick, the at-home test checks for the presence of the AIDS-causing virus in saliva collected by a mouth swab.
The Centers for Disease Control estimate that nearly 20 percent of the over 1 million HIV-infected people in the United States are unaware that they are carrying the virus. FDA officials say OraQuick is aimed at those who may not otherwise get tested.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, told Reuters. “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 stresses that the test is not 100 percent accurate — one clinical trial estimated 92 percent accuracy — and that a positive reading does not necessarily mean that a person has HIV, but that additional testing in a medical setting should be undergone to confirm the result.
The FDA also cautioned against false negatives, which could potentially lead HIV-positive persons to unknowingly spread the virus. Based on clinical trials, one in every 12 results could be a false negative.
The FDA has previously approved take-home HIV test kits, most of which required a blood sample, but the kits had to be developed at a lab and didn’t provide rapid results.
The OraQuick test kit, developed by OraSure Technologies, has been marketed to health care practitioners since 2002. The take-home version will be available both online and at more than 30,000 retailers starting in October, and is expected to retail at a price point higher than the $17.50 charged for professional use. A specific price has not been released, but the company says it will be less than $60.
USA Today reports that the extra cost will help pay for a call center to provide counseling and medical referrals to test users.
“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,” said Douglas Michels, OraSure’s CEO. “So they are highly trained professionals and they’ll be there to support the consumer.”
As of 2010, there were more than 30 million adults living with HIV/AIDS worldwide. OraSure would like to eventually make their take-home test kit available in other countries.