OraSure Investigates False Positives on HIV Test
Last month, a number of clinics and healthcare centers in the New York, Los Angeles, and San Francisco regions reported a higher-than-expected incidence of false positives on the saliva-based OraQuick Advance HIV test, which is manufactured by OraSure Technologies Inc. (Bethlehem, PA). Although most of the affected centers found only mildly elevated false-positive incidence rates, one San Francisco clinic reported that 25% of the population that tested positive using OraQuick showed no evidence of infection on more-traditional, blood-based follow-up HIV tests.
FDA approved OraQuick for HIV-1 testing in November 2002 and for HIV-2 testing in March 2004. The 20-minute test uses saliva to detect the presence of HIV antibodies. Following FDA’s recent announcement that it was considering an HIV test for at-home use, OraQuick was widely believed to be a likely candidate for approval. However, many industry analysts now believe that the reports of false positives will delay expansion of FDA’s approval for any HIV test from clinically supervised settings to at-home use.
Upon learning of the situation, OraSure launched an investigation into the false-positive reports. The company contacted every center that reported a problem, as well as other facilities across the country where no increase in the rate of false positives was noted. The investigation includes ongoing consultations with various city and state health departments, as well as FDA and the Centers for Disease Control and Prevention (CDC; Atlanta). Based on the investigation to date, OraSure said that the reports of false positives appear to represent isolated incidents confined to particular geographic locations.
“ These evaluations include the collection of test data, an assessment of test procedures, specimen collection, and other clinical variables that could affect results at the sites,” said Joanne Hannabery, OraSure’s director of client services. “In addition, we are conducting a comprehensive review of the materials and processes used to manufacture the test. We intend to complete these evaluations as soon as possible.”
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| OraSure’s Michels: An aggressive investigation. |
The company said the great majority of testing centers continue to report a rate of false positives that is consistent with the information printed on the product label. Last November, CDC presented preliminary postmarket surveillance data from the use of OraQuick at 347 sites across the United States. According to the CDC data, a total of 17,220 oral fluid tests were performed with a test reliability rate of 99.8%. This is consistent the company’s FDA-approved label claims.
Some state health officials have speculated that the relatively high rate of hepatitis infection among the population typically seeking HIV testing may have adversely affected the results.
“We are certainly taking seriously the recent reports from these clinical sites, and we have moved aggressively to systematically evaluate each situation as quickly as possible and to report our findings as soon as we are able,” said Douglas A. Michels, president and CEO of OraSure Technologies. “Based on our investigation to date, we remain confident in the overall performance of the test.”
© 2006 Canon Communications LLC
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