应用国产胆碱酯酶试剂盒自建检测系统及其评价

目的：比较分析吉林惠强胆碱酯酶试剂盒在RocheModular及OLYMPUSAU640全自动生化分析仪上建立的检测系统与RocheModular可溯源的参考检测系统检测患者血清CHE结果间的可比性及临床可接受性。方法：依据美国临床实验室标准化委员会（NCCLS）EP9-A文件对2个自检系统与RocheModular参考检测系统检测患者新鲜血清CHE浓度，并进行线性回归与相关及精密度分析。结果：2个自检系统与RocheModular参考检测系统的血清CHE检测结果具有较好的可比性，其相关系数1〉0．99；而2个自建检测系统问血清CHE检测结果可比性还要优于与参考系统问的比较，且精密度CV％〈5％。结论：2个自建检测系统血清CHE检测结果与RocheModular可溯源的参考检测系统相比可被临床接受。

Establishment of self-detection system and its value of domestic-made cholinesterase kit

Objective To analyse the comparable and clinical acceptability of results of testing cholinesterase(CHE)in patients serum between detection system of Jilin Huiqiang CHE kit in the Roche Modular and Beckman-Coulter LX20 automatic biochemical analyzer and the Roche Modular of traceable reference.Method Basing on paper EP9-A of the Committee for Clinical Laboratory Standards(NCCLS),CHE concentration in patients fresh serum through 2 self-detection systems and Roche Modular reference detection system were teste...