胆碱酯酶德国参考方法基础性能研究

Basic performance validation of German reference method for the detection of cholinesterase

目的研究胆碱酯酶德国参考方法性能,并对其进行确认试验和基础性能研究。方法采用混合人血清为基质,制备具有良好稳定性和互通性的不同浓度血清标本,按德国参考方法配制试剂,并在日立全自动生化分析仪7170A上进行精密度试验和线性分析试验。结果精密度试验低值血清标本变异系数(CV)为0.83%,高值血清标本CV为1.07%,两种浓度标本所有测量结果均落在各自均值±3%范围内;线性分析试验直线回归函数方程为Y=2 659 X+4 435,r2=0.998。结论胆碱酯酶德国参考方法性能良好,可用于全自动生化分析仪胆碱酯酶试剂盒的研制及作为对胆碱酯酶参考方法研究开发的基础。

Objective To validate the performance of German reference method for the detection of cholines-terase（CHE） .Methods Mixed human serum were used to prepare samples with different concentrations of CHE and with good stability and interoperability .Reagents were prepared according to the German reference method and preci-sion experiments and linear analysis experiments were performed by using Hitachi 7170A automatic biochemical ana-lyzer .Results Precision experiment indicated that the coefficient of variation of serum sample with low CHE level was 0 .83% ,and that of serum sample with high CHE level was 1 .07% .All detected results were within the range of mean ± 3% .The regression equation was Y=2 659X＋4 435 ,r^2 =0 .998 ,as indicated by linear regression analysis . Conclusion The performance of German reference method for the detection of cholinesterase might be fine ,which could be used for the development of reagents for the detection of CHE on automatic biochemical analyzer and used as foundation for the research and development of reference method .