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Jul 25, 2000

How accurate are the Orasure tests? My AIDS clinic uses them only, yet I hear they're not as accurate as the blood, others say they are, what's the scoop? Thanks!

Response from Mr. Kull

The OraSure HIV-1 Antibody Testing System is an FDA approved alternative to blood testing for HIV antibodies. It is a highly accurate HIV antibody test. Both ELISA and Western Blot tests are available to confirm HIV status on oral specimens. The same window period rules apply for the oral test.

Here's how it works. A cotton fiber pad is placed in between the gum and lower cheek for about two minutes. The collection pad collects oral mucosal transudate (OMT) -- not saliva -- because saliva does not contain enough antibodies for accurate testing. OMT is higher in HIV antibody concentration (if antibodies are present) and contains less contaminants than saliva. The pad is then placed in a preservative solution until it is tested.

The Journal of the American Medical Association (JAMA) issued a statement in 1997 that the OraSure test was 99.9% accurate in both detecting and ruling out HIV antibody presence. The manufacturer of OraSure states in their product information, "The accuracy of the OraSure HIV-1 oral specimen test is lower than that of blood. It has been demonstrated to range from 97.7% in high risk subjects to 99.6% in low risk populations." An investigator stated that the test would give one false positive reading for every 100,000 people tested. I’m sure more information about accuracy will become available as the test is more widely used.

There are several advantages to oral testing. People who are reluctant to have blood drawn may be more likely to use the less invasive oral test. Samples are easier to collect and it’s safer for health care workers. There’s also talk about home testing kits. You can only get the OraSure antibody tests from medical professionals and clinics.

You can call 1-800-ORASURE (672-7873) in the United States to find an office providing oral testing near you.


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