3种丙型肝炎病毒抗体确证试剂检测结果的比较

Comparison of determination results by three confirmatory kits for hepatitis C virus antibody

目的比较不同丙型肝炎病毒(HCV)抗体确证试剂的质量差异。方法应用3种HCV抗体确证试剂(分别命名为确证试剂1、2、3,包括两种进口试剂和一种国产试剂),检测经HCV抗体酶联免疫试剂检测为HCV抗体阳性的45份人血浆样本。结果 45份样本中,确证试剂1、2和3检测阳性的样本分别为31、28和33份,3种确证试剂共同阳性样本28份,共同阴性样本9份,检测结果不一致样本8份;不同确证试剂由于包被的片段不同,检测HCV不同片段的能力不同,确证试剂1对NS3片段的阳性检出率最高,为33份;确证试剂2对NS5片段的阳性检出率最高,为19份;确证试剂3对NS4片段和Core片段的阳性检出率最高,分别为31和34份。结论选择HCV确证试剂,既要考虑不同试剂总体检出情况的灵敏度和特异性,又要考虑每种试剂对每个HCV片段的侧重性,这样才可以兼顾灵敏度和特异性之间的矛盾,使确证试剂真正发挥其在HCV感染诊断的确证作用。

Objective To compare the qualities of various confirmatory kits of hepatitis C virus （HCV） antibody. Meth- ods A total of 45 human plasma samples proved as anti-HCV positive by ELISA were confirmed by three kits, two im- ported and one domestic. Results Of the 45 samples, 31, 28 and 33 were confirmed as positive by kits 1, 2 and 3 re- spectively, while 28 as positive and 9 as negative by all the three kits. However, the confirmation results of 8 samples by various kits were inconsistent. Because of different fragments coated, the abilities of various kits in determination of vari- ous HCV fragments were different. Kit 1 was more effective in determination of NS3 fragment （33 positive）, while kit 2 in NS5 fragment （19 positive）, and kit 3 in NS4 （31 positive） and core （34 positive） fragments. Conclusion The overall sensitivity and specificity as well as the sensitivity and specificity of various kits to various fragments should be considered in selection of confirmatory kit for HCV to give full play to the kits in diagnosis of HCV infection.