53 Rolling Out Rapid HIV Tests in the United States Bernard M Branson CDC, Atlanta, GA, USA

Background: Four new rapid HIV antibody tests have been approved by the U.S. Food and Drug Administration since November 2002. The OraQuick Advance and Uni-Gold Recombigen, performed on whole blood or oral fluid, are waived under the Clinical Laboratory Improvement Amendments (CLIA) and allow point-of service testing. Rapid tests represent the first major change for HIV screening in the U.S. since the enzyme immunoassay (EIA) was introduced nearly two decades ago.

Methods:  Sensitivity and specificity of rapid tests were compared to those of EIA and Western blot on specimens from high-risk persons seeking HIV testing, pregnant women in labor, and from persons offered routine screening in an urban emergency department (ED) and outreach settings.  Training and quality assurance guidelines were developed for the use of CLIA-waived rapid tests by non-laboratory personnel; OraQuick tests were provided to health departments and community-based organizations (CBOs); and projects were initiated to demonstrate the utility of point-of-service rapid testing in medical settings, non-clinical venues, jails, and as part of partner counseling and social network referrals. Surveillance monitored utilization and confirmatory testing in prevention programs in 11 states, and aggregate data on utilization were collected from 36 states and 30 demonstration projects.

Results:  Rapid test sensitivity and specificity ranged from 99.4% - 100%.  Among 4849 pregnant women with 0.7% HIV prevalence, OraQuick sensitivity was 100%; specificity (99.9%) and positive predictive value (90%) exceeded that of conventional EIA (99.8% and 76% respectively). Among other persons tested with OraQuick, HIV prevalence averaged 1% (medical settings), 2% (non-clinical venues), 2% (jails); 5.3% (social networks), and 9% (partner counseling and referral). More than 500,000 tests were distributed to 137 health departments and CBOs. Through June 2004, 116,304 persons were tested and 1,774 (1.5%) were HIV-positive; 12,000 devices were used for training, and nearly 20,000 were used to run external controls.

Conclusion:  Rapid HIV testing is feasible, delivers timely and accurate results, and offers unique opportunities to diagnose HIV infection among the estimated 180,000 to 280,000 persons in the U.S. who are currently unaware they are infected.