title: [Establishment of the evaluation reference system for domestic anti-hepatitis C virus diagnostic enzyme immunoassay kits].
abstract: OBJECTIVE
  To establish the evaluation reference for domestic anti-hepatitis C virus (HCV) enzyme immunoassay (EIA) diagnostic kits.
  
  
  METHODS
  4833 serum samples which were collected from different provinces of China were screened with 5 domestic anti-HCV EIA kits and redetected with 2 foreign anti-HCV EIA kits. Then the selected samples were confirmed with Chiron RIBA HCV 3.0 SIA and real-time quantitative PCR reagents. The confirmed positive samples were examined for HCV genotypes. The positive samples (classified as low, medium and high titers), negative samples, mixed-titer positive dilution samples and special samples were selected for preparing the evaluation reference for anti-HCV diagnostic reagent kits.
  
  
  RESULTS
  The established evaluation reference consisted of 30 positive serum samples including high, medium and low titers, and 10 single band samples confirmed by RIBA, and 6 dilution samples to evaluate the sensitivity, and 30 confirmed negative samples including some high negative value samples and interferential samples.
  
  
  CONCLUSIONS
  The evaluation reference samples could offer dependable detection results, and covered abundant antibody repertoire, thus providing important reference for the improvement of the qualities of domestic anti-HCV EIA kits.
authors.affiliation: Department of Clinical Laboratory, Henan Hospital of Traditional Chinese Medicine, Zhengzhou 450002, China.
authors.forename: Xiaobin
authors.initials: X
authors.lastname: Niu
authors.forename: Xinming
authors.initials: X
authors.lastname: Wang
authors.forename: Gongcheng
authors.initials: G
authors.lastname: Liu
authors.forename: Yongwei
authors.initials: Y
authors.lastname: Li
mesh_terms: D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic