title: Lack of correlation between sensitivity characteristics of the tests for hepatitis C virus antibodies estimated with serially diluted and natural low-reactive control specimens.
abstract: Sensitivity characteristics of seven commercial ELISA test systems for the detection of antibodies to hepatitis C virus were assessed using control panels consisting of: (i) serial dilutions of pooled sera highly reactive for anti-HCV; (ii) serial dilutions of RIBA 3.0 HCV SIA positive control; and (iii) natural (non-diluted, non-spiked) sera low-reactive for anti-HCV. "Dilutional sensitivity" values estimated with these two kinds of highly reactive samples did not coincide and were not found to correlate with the proportion of natural low-reactive specimens detected by each test. Thus, laboratories assessing sensitivity of anti-HCV ELISAs should take into consideration the nature and properties of the control material used. Natural low-reactive control specimens are preferable because they adequately reflect the real serological picture of early stage of HCV infection.
authors.affiliation: Department for Quality Assessment and Proficiency Testing, Russian Research Institute for Metrology, St. Petersburg.
authors.forename: I G
authors.initials: IG
authors.lastname: Bondarenko
authors.forename: P E
authors.initials: PE
authors.lastname: Garrett
authors.forename: I N
authors.initials: IN
authors.lastname: Savinova
authors.forename: Y A
authors.initials: YA
authors.lastname: Sedunova
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000821:virology; D018937:Hepatitis C Antibodies / Q000097:blood*; D018936:Hepatitis C Antigens / Q000097:blood; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D011933:Reagent Kits, Diagnostic