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Journal of Clinical Microbiology, July 2001, p. 2518-2524, Vol. 39, No. 7
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.7.2518-2524.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Fourth-Generation Enzyme-Linked Immunosorbent Assay for the Simultaneous Detection of Human Immunodeficiency Virus Antigen and Antibody

Rebecca D. Saville,1,* Niel T. Constantine,1 Farley R. Cleghorn,2 Noreen Jack,3 Courtenay Bartholomew,3 Jeffrey Edwards,3 Perry Gomez,4 and William A. Blattner2

Department of Pathology, School of Medicine,1 and Institute of Human Virology,2 University of Maryland, Baltimore, Maryland; Medical Research Foundation of Trinidad and Tobago, Port of Spain, Trinidad,3 and Princess Margaret Hospital, Nassau, Bahamas4

Received 27 November 2000/Returned for modification 28 March 2001/Accepted 2 May 2001

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 instrument, 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 seroconversion panels, 9 p24 antigen-only-reactive members of a panel of group M clades, 503 consecutively collected samples from individuals seeking care in the University of Maryland Medical System, 1,010 samples from U.S. blood donors, 1,141 samples from patients in a high-incidence population in Trinidad, 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 Administration-licensed HIV antibody screening, p24 antigen tests, HIV confirmatory assays, and the Roche Diagnostics Amplicor HIV-1 Monitor. The VIDAS HIV DUO Ultra demonstrated 100% sensitivity and 99.5% specificity overall, with a 99.7% specificity in low-risk individuals. The analytical sensitivity, as assessed by seroconversion panels and p24 antigen in samples, was equivalent to the sensitivity of the reference assays used to characterize these panels. The VIDAS HIV DUO Ultra is accurate, offers potential advantages over conventional HIV testing for time and cost savings, has walk-away capability, and correctly identifies both early and established HIV infections.

* Corresponding author. Mailing address: University of Maryland, 725 W. Lombard St. #515, Baltimore, MD 21201. Phone: (410) 750-1721. Fax: (410) 706-2789. E-mail: saviller{at}umbi.umd.edu.

Journal of Clinical Microbiology, July 2001, p. 2518-2524, Vol. 39, No. 7
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.7.2518-2524.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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