三种酶免试剂盒和电化学发光试剂盒检测HCV抗体的比较

目的比较三种酶免试剂盒和电化学发光试剂盒检测HCV抗体的灵敏度、特异性以及相关性。方法采用酶联免疫吸附试验和电化学发光法检测35例临床确诊丙型肝炎患者和45例健康体检者血清,统计学分析采用卡方检验和Kappa检验。结果中山生物、罗氏公司、上海科华、英科新创试剂盒的灵敏度分别为94.3%、100%、94.3%、100%,特异性分别为93.3%、93.3%、97.8%、93.3%。四家公司试剂盒之间检测阳性率差异没有统计学意义(P0.05)。四家公司试剂间均有良好的一致性(Kappa值均大于等于0.8,P均小于0.01)。结论四家公司HCV抗体筛查试剂盒检测结果无显著差异。筛查阳性标本应做进一步确诊试验。

Comparison of HCV antibody detected by three kinds of ELISA kits and electrochemiluminescence kit

Objective To compare the sensitivity and specificity of HCV antibody detected by three kinds of ELISA kits and electrochemiluminescence kit and to analyze their correlation.Methods The serum samples of 35 patients suffering from viral hepatitis C and 45 health persons were detected by enzyme linked immnosorbent assay(ELISA) and electrochemiluminescence assay.The statistical analysis methods were Chi-square test and Kappa test.Results The sensitivities of Zhongshan,Roche,Kehua and Xinchuang were 94.3%,100%,94.3% and 100% respectively and their specificities were 93.3%,93.3%,97.8% and 93.3% respectively.The positive rates of four kits had no significant differences(P>0.05) and there was good consistency among four kits(K≥0.8 and P<0.01).Conclusion The results of four HCV antibody kits had no significant difference and the positive samples in screening tests should make a confirmatory test.