title: Establishment of National Quality Control Reference Panels and Requirements for Hepatitis B diagnosis reagents in China.
abstract: A National Quality Control Reference Panel for Hepatitis B Diagnostic Kits has been established. Markers for these standards which were prepared include National Standards for HBsAg and anti-HBs calibrated against WHO International Standards. In addition, Reference Panels for HBeAg, anti-HBe, anti-HBc, anti-HBc IgM and HBV were established and National Requirements set. These panels have been used for the nationwide evaluation of HB kits and for licensing purposes.
authors.affiliation: National Institute for the Control of Pharmaceutical and Biological Products, Beijing, People's Republic of China.
authors.forename: S
authors.initials: S
authors.lastname: Wu
authors.forename: T
authors.initials: T
authors.lastname: Su
authors.forename: J
authors.initials: J
authors.lastname: Lin
authors.forename: Y
authors.initials: Y
authors.lastname: Chen
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: C
authors.initials: C
authors.lastname: Zhou
authors.forename: Q
authors.initials: Q
authors.lastname: Xu
authors.forename: H
authors.initials: H
authors.lastname: Li
mesh_terms: D002681:China; D006509:Hepatitis B / Q000175:diagnosis* / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D006801:Humans; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D011933:Reagent Kits, Diagnostic