应用国产胆碱酯酶试剂盒自建检测系统及其评价

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

目的:比较分析吉林惠强胆碱酯酶试剂盒在Roche Modular及OLYMPUS AU640全自动生化分析仪上建立的检测系统与Roche Modular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Roche Modular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Roche Modular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γ>0.99;而2个自建检测系统间血清CHE检测结果可比性还要优于与参考系统间的比较,且精密度CV%<5%。结论:2个自建检测系统血清CHE检测结果与Roche Modular可溯源的参考检测系统相比可被临床接受。

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 Elx） - A of tile Committee for Clinical Laboratory Standards （ NC- CLS）, CHE concentration in patients fresh serum through 2 self - detection systems and Roche Modular reference detection system were tested. Linear regression and correlation analysis were done, and U - test to determine whether the data from two detection systems had a significant difference. Results As results of testing CHE in serum had better comparability between 2 self- detection systems and Roche Modular reference detection system. The correlation coefficient （＇,/） 〉 0.99, there were no significant differences （ P 〉 0.05 ）. In addi- tion, comparability in testing results between 2 self- detection systems was superior to Roche Modular reference detection system. Conclusion As results of testing CHE in serum between 2 self - detection systems and Rocbe Modular reference detection system is accepted.