title: Diagnostic evaluation of a new combined HIV p24 antigen and anti-HIV1/2/O screening assay.
abstract: To evaluate a new fourth generation assay for simultaneous detection of antibodies to the human immunodeficiency virus (HIV) 1 and 2 and HIV p24 antigen in daily routine we tested 675 sera obtained from 673 patients and compared the results to conventional antibody tests. In 546 uninfected patients the rate of unspecific reactivities was slightly higher in the new screening assay as compared to conventional antibody assays (1.1% vs. 0.4%). All 121 sera derived from patients with known HIV infection were detected correctly. In six patients from whom sera were obtained during early seroconversion the fourth generation ELISA was positive in three cases, while conventional third generation tests still were negative. In patients negative for HIV antibodies and low amounts of p24 antigen less than 100 pg/ml also the fourth generation ELISA remained negative. Thus, this new assay permits earlier detection of HIV infection and reduces the diagnostic window. It is a reliable tool for routine diagnosis of HIV, especially in blood donors and patients with high risk behavior.
authors.affiliation: Institut für Medizinische Mikrobiologie und Immunologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. polywka@uke.uni-hamburg.de
authors.forename: S
authors.initials: S
authors.lastname: Polywka
authors.forename: J
authors.initials: J
authors.lastname: Feldner
authors.forename: H
authors.initials: H
authors.lastname: Duttmann
authors.forename: R
authors.initials: R
authors.lastname: Laufs
mesh_terms: D000465:Algorithms; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D006679:HIV Seropositivity / Q000175:diagnosis; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods / Q000592:standards
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic