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Clinics Using OraQuick Oral HIV Test Reporting Rates of False-Positive Results Within Limits on Label, OraSure Announces

December 22, 2005

OraSure Technologies on Tuesday in a statement said most sites the company has contacted regarding issues with its oral OraQuick Advance Rapid HIV 1/2 Antibody Test have reported rates of false-positive results within the expected limits that are printed on the product's label, the AP/Business Week reports (AP/Business Week, 12/20). The oral test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the HIV result is negative, and two appear if the result is positive. The San Francisco Department of Public Health earlier this month announced that of 9,400 tests conducted at 14 public health clinics in the city in 2005, 49 HIV-positive results from OraQuick oral tests later were determined to be false positives. In addition, New York City Assistant Health Commissioner Susan Blank said the city recorded 30 false-positive results in November after recording an average of about five false-positive results in previous months. At least six testing sites in San Francisco, New York City and Los Angeles earlier this month discontinued use of the test, and CDC and FDA are investigating reports of false-positive results. The testing sites now use the OraQuick blood test. The rapid blood test, which uses blood collected from a "finger stick," has not had comparable issues with false positives (Kaiser Daily HIV/AIDS Report, 12/20). OraSure said it has met with clinics that have had abnormal numbers of false-positive results from the oral test in order to "expeditiously resolve the issues" (Dow Jones, 12/20). The company on Tuesday also announced it is cooperating with investigations by government agencies, conducting a scientific review of the test and analyzing factors within clinics that might be contributing to false-positive results (Reuters, 12/21).

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