[Study on quality of China made NS3 antigen].
Using anti-HCV antibody screening assay to control the quality for blood is the main measure for preventing transmission of HCV in China. This study is to evaluate the quality of NS3 antigen because of their positive rate to anti NS3 antibody in HCV infected patients and to all kinds of anti-HCV antibody detecting kits, that need NS3 antigen. We collected four China genetically engineered NS3 antigens and other two NS3 antigens came from abroad. The first step is to confirm that the antibody reactivity with coated NS3 antigen is true. The second step is to compare the quality of China made NS3 antigens with NS3 antigens abroad. The results showed that coated NS3 antigen kits have high sensitivity in identifying the positivity of sera from second generation panel, among them that were RIBA-2 indeterminate or negative. Some negative or false positive results by coated Chinese NS3 antigens indicate that manufacturer should make more efforts to ensure the best condition terms for using these antigens.
Yang
Z
Z
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050.
Qi
Z
Z
Zhang
Z
Z
D000956:Antigens, Viral / Q000097:blood*; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D017361:Viral Nonstructural Proteins / Q000276:immunology*; D012697:Serine Endopeptidases; D043583:Nucleoside-Triphosphatase; D053487:DEAD-box RNA Helicases; D000085242:Viral Proteases
D000956:Antigens, Viral; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins; C084422:NS3 protein, hepatitis C virus; D012697:Serine Endopeptidases; D043583:Nucleoside-Triphosphatase; D053487:DEAD-box RNA Helicases; D000085242:Viral Proteases