New York Health Department Stops Using OraQuick Rapid HIV Test Following Hundreds of False Positives

The OraQuick Advance Rapid HIV-1/2 Antibody Test has been discontinued in New York City as a means of HIV testing there.  The <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">faulty test has been delivering unusually high false positive results and the US Centers for Disease Control and Prevention (CDC) have now become involved.  In January 2004, New York clinics introduced and began offering on-site, rapid HIV testing of finger-stick, whole-blood specimens using the OraQuick test.  The following March, the clinics replaced the finger-stick test with an oral fluid test, the OraQuick Advance Rapid HIV-1/2 Antibody Test.

The New York City Department of Health and Mental Hygiene, which operates 10 sexually transmitted disease walk-in clinics, stopped the popular OraQuick Advance Rapid HIV-1/2 Antibody Test over problems with false-positive results.  Beginning in late 2005, the City’s clinics began noticing an unexpected increase in false-positive oral HIV test results.  According to an online June 18 article in Morbidity and Mortality Weekly Report, published by the CDC, the increase subsided after several months.   Use of the OraQuick Advance Rapid HIV-1/2 Antibody Test was suspended for three weeks in December 2005 and replaced with the finger-stick test while New York City health officials investigated the increase in false-positive test results.  The finger-stick tests did not produce any false-positive results.  And, while the OraQuick Advance Rapid HIV-1/2 Antibody Test was re-introduced in late December 2005, all positive test results were followed up with a finger-stick test.

Another false-positive spike in OraQuick Advance Rapid HIV-1/2 Antibody Test results occurred late last year; however, its cause has not been determined and the City health department has stopped the use of the oral fluid test.  Only the finger-stick test is being used.  “These findings underscore the importance of confirming all reactive HIV tests, both from oral fluid and whole-blood specimens,” the report authors wrote.  “In addition, the results suggest that the NYC DOHMH strategy of following up reactive oral fluid test results with an immediate finger-stick whole-blood test reduced the number of apparent false-positive oral fluid test results and might be a useful strategy in other settings and locations,” they added.

In October 2004, OraSure Technologies, Inc. launched its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test as “the first and only U.S. Food and Drug Administration (FDA) approved and CLIA (Clinical Laboratory Improvements Amendments Act of 1988)-waived rapid point-of-care test that provides accurate results for both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.”  A CLIA waiver allows such testing to be used by more than 180,000 sites in the US, including outreach clinics, community-based organizations, and physicians’ offices.

OraSure develops, manufactures, and markets oral fluid specimen collection devices using proprietary oral fluid technologies; diagnostic products, including immunoassays and other in vitro diagnostic tests; and other medical devices. OraSure products are sold in the US and internationally to clinical laboratories, hospitals; clinics; community-based organizations; and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.

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