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NYC health clinics stop use of oral HIV tests due to false positives

An increase in false positives has prompted New York City public health clinics to stop using OraSure Technologies’ OraQuick Advance Rapid HIV 1/2 Antibody Test. City health officials report that over the past eight months, the number of inaccurate tests rose as high as 1.1% -- a rate that is roughly five times higher than the kit’s label claims.

Though the oral test, which uses a swab to collect tissue from the inside of a person’s mouth in order to detect antibodies against HIV, continues to meet U.S. standards and is currently still available on the market, NYC clinics have discontinued using it and have switched to alternative methods of testing which require finger-prick blood screening instead.

According to Susan Blank, city commissioner for STI prevention and control, health officials began noticing problems with the test in October 2007, which continued through April 2008. “So far, the false positives have not been linked to handling, storage conditions, lot numbers, clinic sites, and test operators,” she added. It should also be noted that health clinics in NYC and in other cities have had problems with false positives in the past as a result of the OraQuick test.

OraSure spokesperson Ron Ticho contends that the tests have performed better in other cities, with a false positive rate of 0.2% in more than 250,000 tests used over the past 17 months at 200 sites across the country. “What’s happening in New York City appears to be a slight aberration,” said Ticho. “Performance results may fall slightly outside the expected range for a short period of time. That’s expected.”

According to Ticho, Orasure is following standard company protocol for investigating product performance, and is cooperating with the U.S. Centers for Disease Control and Prevention (CDC) and NYC health officials to try to get an understanding of what went wrong. The CDC is also investigating whether health officials in other cities are experiencing similar problems with the test.

Issues regarding the accuracy of rapid testing underscore the importance of confirming all reactive HIV tests. To read the CDC article published in the Mortality and Morbidity Weekly Report (MMWR), visit CDC.gov.