title: Performance evaluation of the ADVIA Centaur(®) HIV Ag/Ab Combo assay.
abstract: Early diagnosis of HIV infection and appropriate care reduces morbidity and mortality. As a result, recent guidelines recommend that HIV screening be routinely included in patient care. Routine screening will likely result in more patients being tested prior to seroconversion; fourth-generation assays can facilitate diagnosis in these patients. This study evaluated the performance of the automated fourth-generation ADVIA Centaur(®) HIV Ag/Ab Combo assay. Samples from three sites were tested using the HIV Ag/Ab Combo assay and a CE-marked predicate assay. The HIV Ag/Ab Combo assay's relative sensitivity was 98.36% (599/609; 95% confidence interval: 97.00-99.21%), and the relative specificity was 99.74% (7743/7763; 95% confidence interval: 99.60-99.84%). The HIV Ag/Ab Combo assay detected seroconversion at the same bleed or at least one bleed earlier in 34/37 panels compared to the CE-marked predicate assay. Compared to the final result, the HIV Ag/Ab Combo assay's sensitivity was 100% (598/598; 95% confidence interval: 99.39-100.00%), and the specificity was 99.74% (7753/7773; 95% confidence interval: 99.60-99.84%). Sensitivity was 100% for the HIV genotypes tested. The HIV Ag/Ab Combo assay is a sensitive and specific assay that can assist clinicians in the early diagnosis of HIV infection.
authors: University of Barcelona\Fundacion Clinic, Barcelona, Spain.
authors: Tomàs
authors: T
authors: Pumarola
authors: James
authors: J
authors: Freeman
authors: Emeline
authors: E
authors: Saxton
authors: Paul
authors: P
authors: Dillon
authors: Tricia
authors: T
authors: Bal
authors: Josef
authors: J
authors: van Helden
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D042241:Early Diagnosis; D015483:HIV Antibodies / Q000097:blood* / Q000276:immunology; D016655:HIV Core Protein p24 / Q000276:immunology*; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology; D006679:HIV Seropositivity / Q000175:diagnosis / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008403:Mass Screening; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic