丙型肝炎病毒抗体免疫酶快速检测试剂的评价

Rapid Immuno-Enzyme Assay Kit for Antibodies to Hepatitis C

对丙型肝炎病毒抗体免疫酶快速检测试剂(IEA)检测丙型肝炎病毒抗体(HCV-Ab)的性能、结果等技术参数进行评价,为实验室的选用提供参考.采用IEA法、ELISA法和胶体金法对中国生物制品检定所“第三代ELISAHCV-Ab诊断试剂国家参考品”和3297份血清或血浆标本同时测定,对IEA的敏感性、特异性、重复性和检测时间等结果进行评价.结果表明:IEA可通过中国生物制品检定所“第三代ELISAHCV-Ab诊断试剂国家参考品”检验;与ELISA法比较,IEA的检出率为99.06%,灵敏度与ELISA相当,胶体金的检出率为86.01%,灵敏度比ELISA低;IEA检测所需时间15～25min.IEA既有ELISA的敏感性、特异性,又有胶体金简便、快速的特点.适用于献血员及高危人群中HCV抗体的筛查和临床诊断HCV感染,以及门诊、急诊和基层医疗单位的现场检测.

To evaluate the quality and performance of rapid immuno-enzyme assay kit for antibodies to Hepatitis C （IEA） and to provide references for various laboratories during the selection of HCV-Ab assay methods. The third-ELISA HCV-Ab diagnostic reagent for the nation reference and 3297 unknown sera were tested with IEA. ELISA and gold immunochromatography assay （GICA） simultanously. The sensitivity, specificity, repeatability and test time of the IEA were assessed. IEA has passed the check of the third-ELISA HCV-Ab diagnostic reagent provided by NICPBP which used for the nation reference,with detection rates of IEA 99.06% ,It is not less sensitive than ELISA, detection rates of GICA 86.01%,It is less sensitive than ELISA,as compared with ELISA. IEA needed 15 to 25 min to finish the whole course. Conclusions IEA is not only as sensitive and specific as ELISA,but also as convenient and fast as GICA. It is fit for screening HCV-Ab of blood subscribers and highrisk groups,clinically diagnosing HCV infection and for spot detecting of out-patient clinic, emergency and primary level medical units.