抗-HCV ELISA试剂评估结果分析

Result Analysis and Evaluation of Anti-HCV ELISA Reagents

目的用酶联免疫吸附试验(ELISA)的双抗原夹心法和间接法检测抗-HCV,并对不同检测方法的试剂进行评估。方法用1种双抗原夹心法和4种间接法检测抗-HCV血清盘和不同浓度的室内质控品,严格按试剂说明书在Xantus全自动加样仪和FAME全自动酶免分析仪中进行检测。结果经用不同的ELISA法检测抗-HCV后,血清盘中阴性参考品符合率均为20/20,阳性参考品符合率均为20/20。双抗原夹心法灵敏度高,0.05NCU/mL的室内质控品能完全检测出来,间接法最低检出为0.5NCU/mL,间接法的10个单试剂阳性标本用双抗原夹心法和RIBA确认法检测全部为阴性。结论双抗原夹心法的抗-HCV ELISA试剂灵敏度和特异性均优于间接法。

Objective To detect anti-HCV by using the double antigen sandwich method and the indirect method, and to evaluate the reagents in different assay methods. Methods Use 1 double antigen sandwich method and 4 indirect methods to detect anti-HCV blood serum-plate and internal quality controls with different concentrations. The detection is conducted in Xantus Automatic sampling instrument and FAME Fully Automated Enzyme Immunoassay Analyzer according to the reagent instruction strictly. Results After using different ELISA methods to detect anti-HCV, the coincidence rate to negative reference panel （-/-） in all blood serum plates was 20/ 20 and the coincidence rate to positive reference panel （＋/＋） was 20/20. The double antigen sandwich method had a high sensitivity, and it can detect 0.05 NCU/mL of internal quality control completely. The indirect method can detect 0.5 NCU/mL at minimum. All 10 single reagent specimens that showed positive result in the indirect method were confirmed to be negative in the double antigen sandwich method and the confirmatory test RIBA. Conclusion The anti-HCV ELISA reagent in double antigen sandwich method has a higher sensitivity and specificity than those of the indirect methods.