检测丙型肝炎病毒F抗体的一种间接ELISA的初步评价

目的评价以丙型肝炎病毒（HCV）F蛋白为包被抗原的间接酶联免疫吸附试验（ELISA）的准确性和可靠性。方法以基因工程重组HCV F抗原包被酶标微孔板,检测HCV感染者血清抗-F滴度,建立阳性判断值,计算HCV感染者血清抗-F阳性率。与某市售HCV ELISA试剂同时检测HCV感染者和非感染者抗-F阳性率,计算该ELISA的敏感性和特异性等技术指标。结果该间接ELISA检测的敏感性为66.7%,特异性为96.7%,正确指数为63.3%,一致率为81.7%,Kappa值为0.63,变异系数（CV）为6.23%。结论该间接ELISA初步评价指标符合准确性和可靠性要求,具有潜在补充检测HCV感染的扩展应用价值。

Primary evaluation of an indirect ELISA for detecting Hepatitis C virus anti-F antibody

Objective To evaluate the accuracy and reliability of an indirect enzyme-linked immunosorbent assay（ELISA） for detecting antibody to Hepatitis C virus（HCV） F protein.Methods The recombinant HCV F protein was coated in a 96-well microplate as a capture antigen for detecting the anti-F in sera of patients infected with HCV.After the establishment of the cut-off value,the positive rate of anti-F in patients infected with HCV was calculated.Compared with other HCV ELISA kits,the sensitivity,specificity and other parameters of the indirect ELISA were calculated.Results The sensitivity and specificity of the indirect ELISA were 66.7% and 96.7%.The accuracy index was 63.3%,the concordance was 81.7%,and the Kappa value was 0.63.The coefficient of variation（CV） was 6.23%.Conclusions The indirect ELISA meets the requirements of accuracy and reliability.It shows a potential application for anti-F antibody detection in HCV infection as an alternative method.