title: Seven human immunodeficiency virus (HIV) antigen-antibody combination assays: evaluation of HIV seroconversion sensitivity and subtype detection.
abstract: In this study, we evaluated the performance of two prototype human immunodeficiency virus (HIV) antigen-antibody (Ag-Ab) combination assays, one from Abbott Laboratories (AxSYM HIV Ag-Ab) and the other from bioMerieux (VIDAS HIV Duo Ultra), versus five combination assays commercially available in Europe. The assays were Enzygnost HIV Integral, Genscreen Plus HIV Ag-Ab, Murex HIV Ag-Ab Combination, VIDAS HIV Duo, and Vironostika HIV Uniform II Ag-Ab. All assays were evaluated for the ability to detect p24 antigen from HIV-1 groups M and O, antibody-positive plasma samples from HIV-1 groups M and O, HIV-2, and 19 HIV seroconversion panels. Results indicate that although all combination assays can detect antibodies to HIV-1, group M, subtypes A to G, circulating recombinant form (CRF) A/E, and HIV-1 group O, their sensitivity varied considerably when tested using diluted HIV-1 group O and HIV-2 antibody-positive samples. Among combination assays, the AxSYM, Murex, and VIDAS HIV Duo Ultra assays exhibited the best antigen sensitivity (at approximately 25 pg of HIV Ag/ml) for detection of HIV-1 group M, subtypes A to G and CRF A/E, and HIV-1 group O isolates. However, the VIDAS HIV Duo Ultra assay had a lower sensitivity for HIV-1 group M and subtype C, and was unable to detect subtype C antigen even at 125 pg of HIV Ag/ml. The HIV antigen sensitivity of the VIDAS HIV Duo and Genscreen Plus combination assays was approximately 125 pg of HIV Ag/ml for detection of all HIV-1 group M isolates except HIV-1 group O while the sensitivity of Vironostika HIV Uniform II Ag-Ab and Enzygnost HIV Integral Ag-Ab assays for all the group M subtypes was >125 pg of HIV Ag/ml. Among the combination assays, the AxSYM assay had the best performance for detection of early seroconversion samples, followed by the Murex and VIDAS HIV Duo Ultra assays.
authors.affiliation: Laboratoire Claude Levy, Ivry sur Seine, France.
authors.forename: T D
authors.initials: TD
authors.lastname: Ly
authors.forename: L
authors.initials: L
authors.lastname: Martin
authors.forename: D
authors.initials: D
authors.lastname: Daghfal
authors.forename: A
authors.initials: A
authors.lastname: Sandridge
authors.forename: D
authors.initials: D
authors.lastname: West
authors.forename: R
authors.initials: R
authors.lastname: Bristow
authors.forename: L
authors.initials: L
authors.lastname: Chalouas
authors.forename: X
authors.initials: X
authors.lastname: Qiu
authors.forename: S C
authors.initials: SC
authors.lastname: Lou
authors.forename: J C
authors.initials: JC
authors.lastname: Hunt
authors.forename: G
authors.initials: G
authors.lastname: Schochetman
authors.forename: S G
authors.initials: SG
authors.lastname: Devare
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* / Q000821:virology; D015497:HIV-1 / Q000145:classification / Q000276:immunology / Q000302:isolation & purification; D015498:HIV-2 / Q000145:classification / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; 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