Establishment of National Quality Control Reference Panels and Requirements for Hepatitis B diagnosis reagents in China.
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.
Wu
S
S
National Institute for the Control of Pharmaceutical and Biological Products, Beijing, People's Republic of China.
Su
T
T
Lin
J
J
Chen
Y
Y
Wang
Y
Y
Zhou
C
C
Xu
Q
Q
Li
H
H
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
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D011933:Reagent Kits, Diagnostic