Fourth-generation enzyme-linked immunosorbent assay for the simultaneous detection of human immunodeficiency virus antigen and antibody

The VIDAS HIV DUO Ultra, a fourth-generation immunoassay under development for the simultaneous detection of human immunodeficiency virus type 1 (HIV- 1) p24 antigen and antibodies to HIV-1 and HIV-2, was evaluated. The enzyme -linked fluorescence immunoassay, performed on the automated VIDAS instrume nt, is claimed to detect early and established HIV infection. The assay was challenged with a total of 2,847 samples that included 74 members of 10 se roconversion panels, 9 p24 antigen-only-reactive members of a panel of grou p M clades, 503 consecutively collected samples from individuals seeking ca re in the University of Maryland Medical System, 1,010 samples from U,S, bl ood donors, 1,141 samples from patients in a high-incidence population in T rinidad, 83 samples from a clinic for sexually transmitted diseases in the Bahamas, 10 confirmed HIV-1 group O samples, and 16 confirmed HIV-2 samples from the Cote d'Ivoire, Reference tests were U.S. Food and Drug Administra tion-licensed HIV antibody screening, p24 antigen tests, HIV confirmatory a ssays, and the Roche Diagnostics Amplicor HIV-1 Monitor. The VIDAS HIV DUO Ultra demonstrated 100% sensitivity and 99.5% specificity overall, with a 9 9.7% specificity in low-risk individuals. The analytical sensitivity, as as sessed by seroconversion panels and p24 antigen in samples, was equivalent to the sensitivity of the reference assays used to characterize these panel s. The VIDAS HIV DUO Ultra is accurate, offers potential advantages over co nventional HIV testing for time and cost savings, has walk-away capability, and correctly identifies both early and established HIV infections.