title: Evaluation of the sensitivity and specificity of six HIV combined p24 antigen and antibody assays.
abstract: In this study, we evaluated the performance of six HIV combined p24 antigen and antibody (Ag/Ab) assays versus two third-generation anti-HIV antibody assays. The assays were evaluated using p24 antigen panel of 31 HIV-1 subtypes (n = 124), 25 HIV-1 seroconversion panels (n = 176), HIV-1 antibody positive samples including group M subtypes and group O (n = 559), HIV-2 positive samples (n = 110), and unselected HIV negative samples from four French private laboratories (n = 1005). The results showed that overall HIV combined Ag/Ab assays present better performance, when compared to antibody-only assays. However, some differences were observed in the sensitivity of the six HIV combined Ag/Ab assays evaluated. The AxSYM and Murex Combo assays had the best sensitivity score in this study and reduced the window period by 2.0-2.35 days relative to antibody only assays and 1-2.17 days relative to the other combined Ag/Ab assays. Among combined HIV Ag/Ab assays, Genscreen Plus and AxSYM Combo presented the highest specificity, with 99.9% and 99.8%, respectively.
authors.affiliation: Laboratoire LCL, 78, Avenue de Verdun, 94200 Ivry sur Seine, France. t.ly@lablcl.com
authors.forename: Thoai Duong
authors.initials: TD
authors.lastname: Ly
authors.forename: Syria
authors.initials: S
authors.lastname: Laperche
authors.forename: Catherine
authors.initials: C
authors.lastname: Brennan
authors.forename: Ana
authors.initials: A
authors.lastname: Vallari
authors.forename: Anne
authors.initials: A
authors.lastname: Ebel
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hunt
authors.forename: Lynn
authors.initials: L
authors.lastname: Martin
authors.forename: David
authors.initials: D
authors.lastname: Daghfal
authors.forename: Gerald
authors.initials: G
authors.lastname: Schochetman
authors.forename: Sushil
authors.initials: S
authors.lastname: Devare
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D014766:Viremia / Q000097:blood / Q000175:diagnosis
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic