丙型肝炎病毒抗体检测试剂盒的诊断性能评价

目的：通过与国产科华丙型肝炎病毒（HCV）抗体检测试剂盒比较,分析评价意大利Dia.Pro Diagnostic Bioprobes S.r.l公司生产的HCV抗体检测试剂的诊断性能。方法：应用意大利产Dia.Pro丙肝抗体第3代酶免试剂盒（考核试剂）和国产科华丙肝抗体第3代酶免试剂盒（参比试剂）对7948份样本进行检测,检测结果不一致时,应用美国ORTHO DiaGNOSTIC公司第3代重组免疫印迹法3.0试剂盒进行确证,以对结果进行综合分析。结果：考核试剂和参比试剂灵敏度都为100%;考核试剂特异度99.76%,稍稍低于参比试剂的99.99%。考核试剂对HBV感染的病毒性肝炎、类风湿抗核抗体阳性样本检测,特异度为100%。考核试剂的总符合率为99.79%,阳性预测值为98.13%,阴性预测值为100%。用SPSS13.0分析,考核试剂的阳性样本和阴性样本的频数分布图直观效果比较理想;KAPPA值为0.989（P〈0.01）;ROC曲线下面积为0.998。结论：Dia.Pro试剂灵敏度100%,特异度99.76%,对阴阳性有较好的预知能力,与参比试剂KH试剂有很好的一致性,以及较优越的检测性能,是一种优秀的抗-HCV酶免试剂盒,适用于血液筛查和丙型肝炎诊断。

Performance characteristics of Dia.Pro hepatitis C virus antibody kit assay

Objective：To compare the performance of Dia.Pro HCV kit versus the current KH HCV assay in various clinical settings,such as blood banks and hepatology centers.Method：The two ELISA kits were evaluated simultaneously using a total of 7948 specimens.All the results concordant positive for both assays were classified as true positive（TP） or concordant negative for both assays were classified as true negative（TN）.The discordant specimens were further confirmed using RIBA 3.0 for comprehensive analysis.Result：Evaluation kits and reference reagents were all 100% sensitivity.Whereas,the specificity of the former was 99.76% which was slightly lower than that of the latter 99.99%.The specificity of Evaluation kits to detect both Hepatitis B-positive specimens and rheumatoid antinuclear antibodies positive specimens was 100%.The total coincidence rate,positive predictive value and negative predictive value of Dia.Pro was 99.79%,98.13% and100%,respectively.Data were analyzed with SPSS13.0.The results showed that Evaluation kits frequency distribution of positive samples and negative samples had ideal visual effects.KAPPA value was 0.989（P 0.01）;and ROC curve area was 0.998.Conclusion：The sensitivity and specificity of Dia Pro anti-HCV ELISA kit was 99.76% and 100%,respectively.With good prophecy,good agreement with KH anti-HCV ELISA kit and Superior detection performance,Dia.pro was an excellent anti-HCV ELISA kit for blood screening and hepatitis C diagnosis.