Are Oral HIV Tests (OraQuick) Accurate? McGill University Study





Produced by Pennsylvania-based OraSure Technologies Inc., OraQuick is the only saliva test approved for use in a health-care setting by the United States Food and Drug Administration.

Right now, it isn’t available for home use in the U.S., but Dr. Pant Pai says she expects the FDA will do so this year, since the use of OraQuick in hospitals and clinics across the U.S. “has exploded” since the FDA approved it in 2004.

Making the test available to communities where stigma and discrimination prevent people from getting tested at clinics may significantly curb the rise of infections in these communities, health authorities point out.

“Getting people to show up for HIV testing at public clinics has been difficult because of visibility, stigma, lack of privacy, and discrimination,” Dr. Pant Pai says in a Jan. 24 statement to news agencies.

“A confidential testing option such as self-testing could bring an end to the stigmatization associated with HIV testing,” she adds, noting that, “Testing is the cornerstone of prevention, treatment, and care strategies.”

The oral HIV test is also less-invasive and more convenient than blood tests, she observes. “With blood tests, it’s not so easy and some people have a phobia of collecting their own blood. The swab is easy to implement and use. People called it a candy stick,” Dr. Pant Pai says.

Still, self-testing must be followed up by professional care, stresses study co-author Dr. Rosanna Peeling.

“Oral fluid-based Oraquick offers the attraction of being more convenient and non-invasive,” say Dr. Chi Chiu Leung and Dr. Shui Shan Lee from the Chinese University of Hong Kong in a commentary accompanying the published findings.


Because the test is more acceptable, it may promote more access to HIV screening. But while it may do so, “this seems to be at the cost of a substantial false-positive rate — even though the estimated specificity of 99.74 percent might have dwarfed that of most other diagnostic tests in use,” the Hong Kong doctors note.

“This factor must be considered for test interpretation, especially when the availability of such a rapid test allows penetration of screening program into lower-risk groups,” they conclude.

What two percent means
Two percent may seem miniscule, but when dealing with testing on a global scale, even a small percentage drop in accuracy results in large numbers of false-negative or false-positive results, notes writer Elizabeth Armstrong Moore in a blog piece syndicated by CNet.com.

“Still, if considerable numbers of people refuse to go to clinics to be tested, saliva-based self-testing could, at the very least, result in more testing and—one would hope—more precautions among those with a positive result,” Moore surmises.

Not in Canada
One reason it’s taken time for the U.S. FDA to approve the HIV oral self tests for home use is because public health officials are concerned that the tests won’t put those who test positive in touch with support networks they need. This is also why the oral self-sampling test is still not available in Canada.

“We need to be able to connect people to health care if needed,” said Duncan MacLachlan, the AIDS Committee of Toronto’s manager of community health programs. Conducted on-site tests makes it easier for healthcare providers to extend psychological or emotional support if tests show up positive.


Right now there are two types of tests available in Ontario, and they both must be conducted by a healthcare provider in a health clinic setting: the standard HIV test and the rapid point-of-care blood test (it’s a pinprick to draw blood). If a rapid test shows positive, standard tests are given as follow up to confirm the findings.

But MacLachlan says he supports the oral self-sampling tests as another option for HIV detection—if counseling services are somehow included.

Commenting on official reluctance to allow take home tests: “It’s sad because it’s so easy to use,” says Dr. Pant Pai, said. “At the end of the day, it’s about people. If they want it, why are stakeholders getting in the way?”

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