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Oral OraQuick Accuracy Questioned

       Burlington – Despite reports in the Advocate that OraQuick oral swab tests have been showing a high percentage of false positives, the director of Vermont's only agency to use the test remains confident that the test is accurate if used correctly.
       Vermont CARES Director Peter Jacobsen said he is "not concerned," about reports that the swab test that returns results in 20 minutes is showing 25 percent of positive results are false. "We think the finding is site-based – it's in two cities and two specific programs," he explained, echoing OraSure's defense of its testing technology. The company's CEO, Douglas Michels, insisted to an investors' conference that the test has a 99.8 percent accuracy rate for identifying HIV-negative subjects. His numbers are based on results from 112,000 tests performed in 2005 in eight different states, Advocate.com reports.
       "We continue to maintain tight quality control and keep careful records," Jacobsen added.
       Media reports dating from mid-December suggest that the problem may be larger than Jacobsen suggests, with programs in Los Angeles, San Francisco, and New York City all reporting high numbers of false positives. Before it recessed in December, Congress had stripped $12 million in funding for the test from a Health and Human Services budget bill.

       Vermont CARES began offering the OraQuick swab tests in December.
       Kelly Brigham, the agency's Director of Prevention and Service, said Vermont CARES had administered 70 OraQuick oral swab tests from December 1 through mid-January and had no false positives so far.
       "What we'’re hearing from OraSure is that the batch of tests those sites were using might have been expired, or they weren't using them correctly," Brigham added.
      Six sites had dropped the OraSure company's OraQuick oral swab test as of the end of last year, the Advocate reports, quoting the Los Angeles Times. However, the OraQuick rapid-result test that uses blood (from a finger stick or other blood sample) is not showing higher than expected false positives. Some sites confirm oral-swab positive results with a finger-stick test.
       Brigham said that Vermont CARES does not offer the finger-stick OraQuick test because the agency does not meet health and training standards for handling blood products safely. "Handling blood is a biohazard issue, and it takes a certain level of training. We'd already been offering an oral test for three years, so we went with the oral version," Brigham explained.
        As of late December, other well-known HIV test clinics, including the Whitman-Walker Clinic in Washington, DC, Gay Men's Health Crisis in New York, and the AIDS Healthcare Foundation in Los Angeles, were continuing to use the test and have not found a problem with high percentages of false positive results.



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