丙型肝炎病毒抗体胶体金免疫层析法的建立

Development of Hepatitis C Virus Antibody Colloidal Gold Immunization Assay

目的建立一种快速定性检测人血清丙型肝炎病毒(HCV)抗体的方法。方法根据双抗原夹心法的实验原理,建立胶体金免疫层析法检测人血清中丙型肝炎病毒抗体。结果检测中国食品药品检定研究院快速法丙型肝炎病毒抗体国家参考品,20份阴性参考品、20份阳性参考品符合率均为100%;最低检出限参考品L1(1∶8,1∶16)和L2(1∶64,1∶128)均能检出阳性;平行测定10条重复性参考品,全部阳性且显色强度一致。检测1050份血清,与酶联免疫法的符合率达到96.9%。经RIBA复核确认,本方法灵敏度为97.9%,特异性为99.0%。结论本分析方法提供了一种更方便、快速的检测人血清中的HCV抗体的方法,具有很大的临床价值。

Objective To establish a rapid colloid gold method to determine hepatitis C virus antibody in patients＇ serum. Methods The anti-HCV antibodies in sera of human were detected by using a double-antigen sandwich gold immunochromatographic assay（GICA）. Results Testing the national reference panel for anti-HCV and the true positive rate was 100% and the true negative rate was 100%. The sensitivity was 1：16 (L1) and 1 ： 128 (L2). Parallel determination of 10 trips of precision reference and the results were all positive and the color level was the same. For the evaluation of 1050 serum samples, the sensitivity of the strip rapid test method was 96.9% agreeable with enzyme-linked immunoassay. Conclusion By the RIBA, the diagnostic specificity and accuracy of anti-HCV were 97.9 % and 99.0%. Conclusion：We developed a GICA system for detecting anti-HCV antibodies, which can be widely used in clinical testing.