title: A new second-generation anti-HIV-1 enzyme immunoassay using recombinant envelope and core proteins.
abstract: In a multicenter collaborative study a new second-generation HIV-1 antibody enzyme immunoassay (Abbott recombinant HIV-1 EIA) using Escherichia coli-expressed recombinant p24 and p41 proteins as solid-phase antigens was compared with the first-generation H9 cell-line-based Abbott HIV-1 EIA. The results of the confirmatory assays (Western blot, immunofluorescence), combined with clinical information, were used as the reference standard for the detection of HIV-1 antibodies in 10,676 random blood donor serum specimens, in a panel of 840 specimens from symptomatic and asymptomatic patients and a total of 63 serial blood specimens from 23 people at risk. With fresh blood donor sera, the specificity of the first-generation assay ranged between 99.54 and 99.76% (95% confidence limits, CL) compared with 99.81-99.95% (95% CL) for the second-generation EIA. With panel specimens the recombinant HIV-1 EIA achieved an overall sensitivity of 100% and a specificity range of 98.3-99.7% (95% CL); the corresponding sensitivity and specificity ranges observed for the first-generation EIA were 98.0-99.5% (95% CL) and 94.3-96.8% (95% CL), respectively. The improved sensitivity for the second-generation assay was confirmed by testing serial samples from seroconverting patients. The use of recombinant proteins eliminated non-specific reactions due to class II human leukocyte antigen (HLA)-directed antibodies.
authors.affiliation: Red Cross Blood Donor Service, Bavarian Red Cross, Munich, FRG.
authors.forename: U
authors.initials: U
authors.lastname: Bäcker
authors.forename: A
authors.initials: A
authors.lastname: Gathof
authors.forename: J
authors.initials: J
authors.lastname: Howe
authors.forename: E
authors.initials: E
authors.lastname: Strobel
authors.forename: F
authors.initials: F
authors.lastname: Deinhardt
authors.forename: L
authors.initials: L
authors.lastname: Gürtler
authors.forename: P
authors.initials: P
authors.lastname: Grob
authors.forename: H
authors.initials: H
authors.lastname: Joller-Jemelka
authors.forename: P
authors.initials: P
authors.lastname: Kühnl
authors.forename: S
authors.initials: S
authors.lastname: Seidl
mesh_terms: D001782:Blood Donors; D003951:Diagnostic Errors; D015483:HIV Antibodies / Q000032:analysis*; D015488:HIV Antigens / Q000276:immunology; D016655:HIV Core Protein p24; D015700:HIV Envelope Protein gp41; D006679:HIV Seropositivity / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D008403:Mass Screening; D015337:Multicenter Studies as Topic; D011994:Recombinant Proteins / Q000276:immunology; D012191:Retroviridae Proteins / Q000276:immunology; D014759:Viral Envelope Proteins / Q000276:immunology
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens; D016655:HIV Core Protein p24; D015700:HIV Envelope Protein gp41; D011994:Recombinant Proteins; D012191:Retroviridae Proteins; D014759:Viral Envelope Proteins