OraQuick Oral HIV Test Accurate Despite Reports of False-Positive Results, OraSure CEO SaysOraSure Technologies' oral OraQuick Advance Rapid HIV 1/2 Antibody Test has been proven accurate, despite recent reports of false-positive results, OraSure CEO Douglas Michels said on Tuesday at a Needham & Company investor conference in New York City, Knight Ridder/Allentown Morning Call reports (Kennedy, Knight Ridder/Allentown Morning Call, 1/11). 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 in December 2005 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 2005, after recording an average of five false-positive results in previous months. At least six testing sites in San Francisco, New York City and Los Angeles in December 2005 discontinued use of the test, and CDC and FDA are investigating reports of false-positive results. OraSure said it has met with clinics that have had abnormal numbers of false-positive results from the oral test in order to resolve the issues. The company last month 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 (Kaiser Daily HIV/AIDS Report, 12/22/05).
The OraQuick oral test has a 99.8% accuracy rate -- a figure based on results from tests used in eight states last year, including those that reported increases in false-positive results -- Michels said. He added that the accuracy rate is in line with what is printed on the product's label. In addition, reports of higher-than-expected false positives are limited to a few sites and likely are unrelated to particular test lots, according to Michels. Other factors specific to testing sites, such as human error or the testing population, might be playing a role in the false-positive results, Michels said. He added that studies are being conducted to determine if factors -- including lot variation, product shelf life, blood collection techniques and site conditions -- are affecting oral OraQuick test accuracy. The studies likely will take several weeks to complete, according to Michels (Knight Ridder/Allentown Morning Call, 1/11).