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OraSure says
rapid HIV test problem is localized

OraSure says
rapid HIV test problem is localized

OraSure Technologies said Tuesday that a majority of sites using its oral rapid HIV antibody test reported low rates of false positives, as the company responded to reports of a large number of incorrect diagnoses at certain clinics in California and New York City. The company said it contacted its customers throughout the country following reports of the false positives and found that most of the sites using its mouth-swab test had false-positive rates within the label claims for the product.

"This is helping progress the company's investigation into site-specific factors which may be contributing to unexpected results recently reported," the company said in a statement.

In early December, San Francisco officials said that a quarter of those the OraSure test identified as HIV-positive at city clinics did not have the disease. Last week the Los Angeles Gay and Lesbian Center said it would stop using the test after it resulted in 13 false positives. Meanwhile, clinics in New York City showed an increase in false positives, from 10 in October to 30 in November.

OraSure said it continues to investigate what caused the large number of false positives in conjunction with government regulatory agencies and said it is working to resolve issues at the sites that saw abnormal results.

The Food and Drug Administration approved the test in 2004, and the company launched it that November. (AP)

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