Originally published January 9 2006
San Francisco officials claim new HIV test may be flawed
by Mike Adams, the Health Ranger, NaturalNews Editor
San Francisco Department of Public Health officials report that the OraQuick Advance HIV test, which analyzes fluid swabbed from the mouth to provide fast results, has produced 47 false positives at city health clinics, creating serious concerns about the reliability of the test.
A promising new oral HIV test being considered for home use has produced at least 47 false positives at San Francisco public health clinics, throwing a scare into those who received the results and raising questions about the test's suitability for widespread use in the United States and abroad.
The OraQuick Advance HIV test approved for professional use by the Food and Drug Administration in March 2004 detects in just 20 minutes antibodies to the virus that causes AIDS, using fluid swabbed from the mouth.
Its speed and ease of use make the test a particularly suitable candidate for HIV prevention and treatment efforts that stress frequent testing and speedy access to care for those who test positive.
Dr. Jeffrey Klausner, the city's director of sexually transmitted disease prevention and control services, said about 1 out of 4 of the roughly 200 positives detected by the new oral test turned out to be wrong.
He said there have been no known instances in which the oral test has missed an HIV infection that otherwise would have been detected by traditional blood screening.
As a result of the spate of false positives, Klausner no longer uses the oral test at City Clinic, the health department's primary locale for testing for syphilis, gonorrhea and HIV.
The San Francisco findings have been forwarded to the state Office of AIDS, the Centers for Disease Control and Prevention in Atlanta, and to the test maker.
In a telephone interview, Orasure Technologies chief executive Douglas Michels said no similar problems with the test have been reported outside of San Francisco.
"This doesn't mean that a site may report unusual results, but that is normal in the course of business with any kind of laboratory test,'' Michels said.
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