A rapid oral test that collects mouth fluids to diagnose HIV is nearly as accurate as traditional blood tests and could help to curb the global HIV/AIDS epidemic, a new study has found.
In a study published Tuesday in The Lancet Infectious Diseases, a group of researchers, led by the Research Institute of the McGill University Health Centre, compared field research studies from five global databases of two rapid test methods — blood tests and an oral fluid test, OraQuick HIV ½.
Researchers found that the oral test was just as effective as the blood test in detecting the virus among high-risk adult populations (injection drug users, men who have sex with men and people having unprotected sex) — and about 97 per cent effective for low-risk populations.
“If you’re really talking about bringing the virus to its knees . . . the oral test is one more way for people to find out their status,” said Dr. Nitika Pant Pai, a McGill medical scientist and the study’s lead author.
OraQuick, a self-sampling test produced by Pennsylvania-based OraSure Technologies Inc., is the only oral fluid test approved for use in a health-care setting by the Food and Drug Administration in the United States. The test is not yet available for home use.
For Pant Pai, the test — which she expects will become FDA-approved for home use in the coming year — offers enormous potential in communities where stigma and discrimination prevent people from getting tested at clinics. It’s also less-invasive and more convenient than its blood-drawing counterpart, she said.
“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,” Pant Pai said.
Often called a “saliva” test, the oral test absorbs fluid called oral mucosal transudate in the mouth’s blood vessels. Users swab the cotton-tipped stick around their entire outer gums and place the stick into the bottom of the vial filled with enzyme solution.
A reddish-purple line appears at the top of the stick if HIV antibodies are found. The line does not mean a positive result, but that a reaction took place. The user would then consult a health-care provider for a test to confirm the result.
The whole process takes about 20 minutes, compared to the standard blood test which takes about two weeks for results.
Though it’s become one of the most popular HIV testing methods worldwide, the HIV oral self-sampling test is not available in Canada. Health Canada licensed a rapid HIV test (a pinprick to draw blood) in 2005 — but that test must be conducted by a health-care provider in a health clinic setting.
One of the concerns surrounding HIV self-testing involves the support networks available to people who may test positive, said Duncan MacLachlan, the AIDS Committee of Toronto’s manager of community health programs.
“We need to be able to connect people to health care if needed,” said MacLachlan, adding that health-care providers can extend psychological or emotional support if tests are conducted on-site.
Two types of HIV tests are available in Ontario — the standard HIV test and the rapid point-of-care blood test. Positive results from a rapid test are usually followed up with a standard test to confirm findings.
MacLachlan said he supported oral self-sampling tests as another option of HIV detection if counselling services were involved in the process.
Dr. Rita Shahin, Toronto Public Health’s associate medical officer of health, said self-sampling tests could help abate the virus’ spread in high-risk regions, such as sub-Saharan Africa.
“It has got a lot of potential, increasing access for people to get tested, especially those who feel more comfortable at home,” she said.
But the standard blood test remains the most reliable option in detecting HIV antibodies, she added.
Pant Pai said OraQuick use “has exploded” in the U.S. since it was FDA-approved in 2004. Meanwhile, the Kenyan government has announced controversial plans for HIV self-testing initiatives, including the possible approval of oral tests.
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