3个不同检测系统血糖测定结果的偏倚评估

Comparability Research on Blood Glucose Results among 3 kinds of Detection Systems

目的通过对3个检测系统进行方法对比分析,探讨各系统之间检测血糖(Glu)结果偏倚是否可以接受。方法参照NCCLS《EP9-A2文件》的要求,以可溯源的检测系统为目标检测系统,采用己糖激酶法或葡萄糖氧化酶法测定Glu,对本院3个不同检测系统进行朗道质控物(水平2和水平3)各测定20次和测定新鲜血浆标本48份。结果朗道质控物和新鲜血浆标本Glu测定经随机区组设计资料的方差分析,各检测系统间的总体差异均有显著性(P<0.001)。各检测系统新鲜血浆标本Glu测定可靠性系数α为0.9993,各系统间的相关系数均大于0.975。各检测系统测定Glu的精密度变异系数均小于3.3%,以可溯源的检测系统1为目标检测系统,临床可接受性能评价各系统均未超过T±5%范围。结论3个不同检测系统测定Glu结果存在偏倚,但具有可比性。

Objective Discuss the comparability of blood glucose（Glu） results with 3 detection systems, Methods Third different kinds of biochemistry detection systems were used to detect plasma Glu concentrations at 2 levels of Randox quality controls and 48 clinical plasma according to EP9-A2 file. The collected data were deal with statistics analysis. Results Analysis of variance showed Glu results from different control and patients plasma have significant difference in various detection system （P〈0.001）. The correlation coefficient of each detection system was above 0.975 and the reliability coefficient of them was 0. 9993. The CV value of All detection systems was not excelled T±3.3% by precision assessment. Target system 1 was regarded as standard detection system and evaluated the acceptability of other detection system. As a result, All detection systems were not excelled T±5% by clinic assessment. Conclusions The precision of Glu results in the 3 kinds of detection systems accorded to clinic requirement.