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)