To perform an oral test, the tester takes the device that has an absorbent pad at one end, places the pad above a person’s teeth along the outer gum, and swabs once around both the upper and lower gums. The tester then inserts the device into a vial containing the developing solution.
In 20 minutes, the device indicates whether HIV-1 or HIV-2 antibodies are present. If one line appears on the strip, it means that the person is not infected with HIV (with 99.8% accuracy). If two lines appear, the person is likely infected (99.3% accuracy). If the result is positive, it has to be confirmed with an additional, more specific test.
Typical HIV tests require an entire vial of blood and take up to 2 weeks to get results. Two years ago, the FDA approved a rapid HIV test that uses only a drop of blood and gives results within 20 minutes.
Hospitals use these rapid HIV screening tests mostly to tell if health workers have been exposed to HIV-infected blood and to test women in labor who had not been previously checked. This way, workers and newborns can get anti-HIV drugs immediately, to possibly prevent infection. In 2003, the CDC emphasized the use of these rapid HIV screening tests at shelters, drug treatment centers, and other nonmedical facilities. The new rapid oral tests are the same kind of HIV test as the one used to rapidly test blood specimens. The difference is that the tests now include a way to collect the oral fluid from the gums.
When the rapid oral HIV test started being used, the maker of the test was not able to sell it outside of hospitals, large health clinics, and certified laboratories. A law restricted the performance of certain medical tests to certified laboratories, and a waiver was needed before the oral test could be sold to outreach clinics and other noncertified medical settings. However, in June 2004, the waiver for the test was received, and now both tests are allowed to be sold outside of certified medical settings.
The cost for the new tests is about $8 per test for public health officials and $8-$20 for other organizations. This is comparable to the price of the rapid blood test.
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