title: Evaluation of a new combined antigen and antibody human immunodeficiency virus screening assay, VIDAS HIV DUO Ultra.
abstract: 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.
authors.affiliation: Laboratoires Réunis Kutter-Lieners-Hastert, Junglinster, Luxembourg, Germany. web@labo.lu
authors.forename: Bernard
authors.initials: B
authors.lastname: Weber
authors.forename: Annemarie
authors.initials: A
authors.lastname: Berger
authors.forename: Holger
authors.initials: H
authors.lastname: Rabenau
authors.forename: Hans Wilhelm
authors.initials: HW
authors.lastname: Doerr
mesh_terms: D015492:AIDS Serodiagnosis; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood; D006679:HIV Seropositivity / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification; D015498:HIV-2 / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D007124:Immunoenzyme Techniques; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic