OraSure: "Test Is Performing Well"
January 12, 2006
At an investor conference Tuesday, OraSure Technology CEO Douglas Michels said the company's OraQuick oral rapid-result HIV test appears to be performing well despite recent reports of false positives. At least six testing centers -- including some in New York, Los Angeles, and San Francisco -- stopped using the test after saying it found a higher than normal number of false positives.
At the meeting in New York City, Michels said the test has been 99.8 percent accurate in identifying people who do not have HIV. That figure matches the company's claims for the test and is based on the outcome of 112,000 tests performed last year in eight states, including those where the problem has been reported.
The false positives have been limited to a few sites, Michels said, and there is no correlation between the bad results and particular lots of the test. "These findings suggest that a site-specific factor could be playing a role," Michels said, such as the people administering the test or the population being tested. Field studies now underway are focusing on several variables that could affect the test's performance, such as lot variation, shelf life, specimen collection, and site-specific factors.
At present, the OraQuick test is only approved for use by medical professionals, but the company is seeking government approval to sell it directly to the public.
Morning Call (Allentown, Pa.)
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This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.