title: [Initial experiences with HCV detection and confirmation tests of the 3rd generation].
abstract: We compared the reactivity of a new 3rd-generation anti-HCV enzyme immunoassay (EIA) using an additional, nonstructural antigen from the NS5 region, with a currently used 2nd-generation anti-HCV EIA, by investigating 419 serum specimens from healthy blood donors with normal liver function and 256 samples from patients at risk for hepatitis C infection; 2 of 419 blood donors and 1 of 256 patients were reactive to the NS5 region antigens only (later confirmed by Western blot and RP-2 RIBA), whereas 1 patient was reactive with the 2nd-generation EIA only (antibodies against c33c). We further evaluated the recently developed anti-HCV RP-2 RIBA by testing samples, that were indeterminate by the 2nd-generation RIBA. Nine of 15 patients were identified as reactive by RP-2 RIBA, 6 remained indeterminate. Of the 6 blood donor samples tested, 2 were found reactive, 1 remained indeterminate, and 3 were negative. These test results suggest a higher sensitivity and specificity of the RP-2 RIBA, whereas the relevance of an isolated NS5 EIA reactivity remains to be established.
authors.affiliation: Abteilung für Transfusionsmedizin und Transplantationsimmunologie, Universitäts-Krankenhaus Eppendorf, Hamburg.
authors.forename: B
authors.initials: B
authors.lastname: Knödler
authors.forename: P
authors.initials: P
authors.lastname: Kühnl
mesh_terms: D000956:Antigens, Viral / Q000097:blood*; D001782:Blood Donors; D001803:Blood Transfusion; D006526:Hepatitis C / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D018936:Hepatitis C Antigens; D006801:Humans; D007124:Immunoenzyme Techniques; D008403:Mass Screening; D006435:Renal Dialysis; D012307:Risk Factors
chemical_list: D000956:Antigens, Viral; D018936:Hepatitis C Antigens