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Journal of Clinical Microbiology, April 2002, p. 1420-1426, Vol. 40, No. 4
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.4.1420-1426.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Evaluation of a New Combined Antigen and Antibody Human Immunodeficiency Virus Screening Assay, VIDAS HIV DUO Ultra

Bernard Weber,1,2* Annemarie Berger,2 Holger Rabenau,2 and Hans Wilhelm Doerr2

Laboratoires Réunis Kutter-Lieners-Hastert, Junglinster, Luxembourg,1 Institut für Medizinische Virologie, Universitätskliniken Frankfurt, Frankfurt, Germany2

Received 10 August 2001/ Returned for modification 25 September 2001/ Accepted 22 January 2002

Combined antigen and antibody screening (fourth-generation) assays reduce the diagnostic window period between the time of human immunodeficiency virus (HIV) infection and laboratory diagnosis by 4 days, on average, in comparison to antibody-only (third generation) enzyme immunoassays (EIAs). The aim of the present study was to assess whether the new VIDAS HIV DUO Ultra (Biomérieux, Marcy-l'Etoile, France) showed an improved sensitivity and specificity in comparison to licensed fourth-generation assays. A total of 16 seroconversion panels, 15 cell culture supernatants infected with different HIV type 1 (HIV-1) subtypes, and 257 potentially cross-reactive serum samples were tested with VIDAS DUO HIV Ultra, Genscreen Plus HIV Ag-Ab, Enzygnost HIV Integral, Enzymun-Test HIV Combi, Genscreen HIV 1/2, version 2 (third-generation EIA), and Genetic Systems HIV-1 Ag EIA (p24 antigen assay). VIDAS HIV DUO Ultra showed a comparable sensitivity to the single p24 antigen assay in seroconversion panels and a dilution series of virus lysates. The diagnostic window was reduced with VIDAS HIV DUO Ultra by 3.82 days, on average, in comparison with the fourth-generation assay with the lowest sensitivity of the antigen detection module. HIV-1 infection was detected 5.88 days earlier than with third-generation EIA. The mean time delay between reverse transcription-PCR and VIDAS HIV DUO Ultra was only 2.31 days. The specificity of fourth-generation assays after retesting ranged between 98.1 and 100%. In conclusion, VIDAS HIV DUO Ultra can replace single-antigen screening for laboratory diagnosis and screening of HIV infection in blood donors. There was no evidence for a second diagnostic window due to impaired sensitivity of the antibody detection module of all the fourth-generation EIAs evaluated in the present study. The specificity after initial and/or repeated testing of VIDAS HIV DUO Ultra was equivalent to that of a third-generation assay.

* Corresponding author. Mailing address: Laboratoires Réunis Kutter-Lieners-Hastert, Centre Langwies, L-6131 Junglinster, Luxembourg. Phone: (352) 78 02 90 309. Fax: (352) 78 88 94. E-mail: web{at}labo.lu.

Journal of Clinical Microbiology, April 2002, p. 1420-1426, Vol. 40, No. 4
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.4.1420-1426.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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