The establishment of HCV IgG antibody chemiluminescence detection method and preliminary application / 中华检验医学杂志

ABSTRACT

Objective To establish a chemiluminecentdetection method ( CLIA ) of HCV IgG antibody for the detection of HCV infection and therefore lay a foundation for the research and development of testing kit.Methods Based upon the indirect ELISA method, the microwell plate was coated with HCV-NS3 and HCV-Core antigen expressed through gene engineering, and the anti-human IgG antibody was labeled with horse radish peroxidase.In this way, the chemiluminesent detection method of HCV IgG antibody was established.Meanwhile, the serum specimen of randomly selected 198 patients infected with HCV from No.302 Hospital of PLA and 222 blood donors, and the results were compared.Results The HCV-IgG antibody, a positive consistent rate of 99.0%( 196/198 ) , a negative consistent rate of 98.2%(218/222), and a total consistent rate of 98.6%(414/420) were found through testing 420 serum specimen with self-made agent and contrast agent.One HCV positive serum was repetitively tested with the self-made agent for 10 times, and a coefficient of variation ( CV) of less than 10% was found.Conclusion The chemiluminescent detection method of HCV IgG antibody is initially established, and the method, with an outstanding specificity and sensitivity, is applicable for screening blood donors, clinically detecting HCV infection as well as epidemiological survey.