In January 2004, the clinics introduced on-site, rapid HIV testing of finger-stick, whole-blood specimens using the OraQuick test. However it was replaced by the finger-stick test with an oral fluid test, the OraQuick Advance Rapid HIV-1/2 Antibody Test in the same year in March.
Following a large number of false-positive results, the use of oral fluid tests was suspended for three weeks in December 2005 and replaced with the finger-stick test. The oral fluid test was re-introduced in late December 2005. However, any positive result from an oral fluid test had to be followed up with a finger-stick test.
In late 2007, there was yet another large surge in the incidence of false-positive oral fluid tests, which has led the city health department to suspend the use of the oral fluid test. Only the finger-stick test is being used. Orasure said it is working with the NYC Department of Health and the Centers for Disease Control and Prevention to better understand the performance at the STD clinic sites.
Acknowledging that there always is a small possibility of false positive results, Orasure Technologies maintains that the test is 99.8 percent accurate. With the ongoing investigation, the CDC is considering publishing an alert for health officials in its weekly report.
