title: Multicenter evaluation of a new, automated enzyme-linked immunoassay for detection of human immunodeficiency virus-specific antibodies and antigen.
abstract: A collaborative multicenter study was conducted to evaluate the sensitivity, specificity, and precision of a three-step, fully automated, qualitative microparticle-based enzyme-linked immunoassay (AxSYM HIV Ag/Ab Combo; Abbott Laboratories), designed to simultaneously detect (i). antibodies against human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) and (ii). HIV p24 antigen. A significant reduction in the HIV seroconversion window was achieved by combining detection of HIV antibodies and antigen into a single assay format. For 22 selected, commercial HIV seroconversion panels, the mean time of detection with the combined-format HIV antigen-antibody assay was reduced by 6.15 days compared to that with a similar third-generation single-format HIV antibody assay. The quantitative sensitivity of the combination assay for the p24 antigen (17.5 pg/ml by use of the p24 quantitative panel VIH SFTS96') was nearly equivalent to that of single-format antigen tests. The combination assay demonstrated sensitive (100%) detection of anti-HIV immunoglobulin in specimens from individuals in CDC stages A, B, and C and from individuals infected with different HIV-1 group M subtypes, group O, or HIV-2. The apparent specificity for hospitalized patients (n = 1938) was 99.90%. In a random population of 7900 volunteer blood donors, the specificity (99.87%) was comparable to that of a third-generation single-format HIV antibody assay (99.92%) on the same donor specimens. In addition, the combination assay was robust to potential interfering specimens. The precision of the combination was high, with intra- and interrun variances of <or=9.3% for each precision panel specimen or assay control and <or=5.3% for the negative assay control.
authors.affiliation: Abbott Diagnostika GmbH & Co KG, Wiesbaden, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Sickinger
authors.forename: Myriam
authors.initials: M
authors.lastname: Stieler
authors.forename: Boris
authors.initials: B
authors.lastname: Kaufman
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Kapprell
authors.forename: Daniel
authors.initials: D
authors.lastname: West
authors.forename: Arnold
authors.initials: A
authors.lastname: Sandridge
authors.forename: Sushil
authors.initials: S
authors.lastname: Devare
authors.forename: Gerald
authors.initials: G
authors.lastname: Schochetman
authors.forename: J C
authors.initials: JC
authors.lastname: Hunt
authors.forename: David
authors.initials: D
authors.lastname: Daghfal
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24