两种酶免检测系统检测相同项目的比对研究

A Comparative Study of the Performance of Two ELISA Automatic Aalyzers

目的评价Liswell应急酶免检测系统和FAME24/20全自动酶免检测系统使用相同试剂检测同一项目所得结果的一致性,并对Liswell应急酶免检测系统进行使用前性能确认。方法 Liswell应急酶免检测系统为X系统,FAME24/20全自动酶免检测系统为Y系统;使用X、Y系统及相同的HBs Ag、抗-HCV、抗-HIV及TP四种试剂盒,每天检测四种试剂盒的内部质控品和同一外部质控品,并且连续20天重复实验,分别在同一块微板内进行同一批次检测20孔质控品和50例血液标本,计算批间CV值,进行χ2检验和Kappa一致性检验。结果 X和Y系统检测结果批间CV值均<15%,结果符合率为100%(K=1),X和Y系统经χ2检验差异无统计学意义(P>0.05)。结论这两种酶免系统的检测结果具有一致性,X系统完全可以配合Y系统同时应用于血液标本的免疫项目检测。

Objective To study the consistency of testing results between Liswell ELISA automatic analyzer and FAME24 /20 analyzer,and evaluate the performance of the new Liswell ELISA automatic analyzer. Methods Four kinds of ELISA reagents were used to test the quality of the control sera of HBs Ag,anti-HCV,anti-HIV,and TP in 50 routine blood samples,respectively.Test methods,χ2and Kappa were applied in parallel for statistical analysis of performance of the two instruments. Results The agreement of the two instruments was 100%. No significant difference was observed by the χ2test（ P 0. 05）. Conclusion The consistency of the two instruments is satisfactory and both can be applied to the immune test of blood samples.