Wesolowski, L., Burstein, G., Mackellar, D., Branson, B.
Diagnostic Applications, Division of HIV and AIDS Prevention,
NCHSTP, Centers for Disease Control and Prevention
Background: In January 2003, OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc.) became the first HIV antibody test to receive a Clinical Laboratories Improvement Amendment (CLIA) waiver. In order to increase the use of rapid HIV tests, CDC purchased and distributed rapid test kits to over 100 state and local health departments, community based organizations, and other testing entities. Post-marketing surveillance (PMS) was conducted to monitor Oraquick rapid HIV test accuracy and utilization, evaluate discordant confirmatory test results, and characterize quality assurance methods and outcomes.
Methods: From July 2003 to December 2003, 14 project areas participated in PMS-1 (phase 1 of PMS). Phase 2 of PMS (PMS-2) will be conducted from August 2004 to June 2005 in 18 project areas. HIV testing surveillance data was submitted to CDC for analysis during PMS-1. Additional follow-up was conducted on discordant test results which had a reactive Oraquick and either non-reactive EIA or negative or indeterminate Western blot or IFA. Historical 2002 data was requested from project areas for the same time period that PMS-1 was conducted in 2003.
Conclusions: Rapid HIV testing was widely used in the surveillance area during PMS-1. The incidence of discordant cases was relatively rare (1/1000). A greater proportion of persons received their rapid HIV test results in 2003 than conventional test results in 2002.

Last Update: April 8, 2005