两个不同检测系统血糖测定结果的偏差评估与可比性研究

Comparability research on blood glucose results among 2 kinds of detection systems

目的通过对两个检测系统（OlympusAU640和Vitros350）方法进行对比分析，评估两个系统间检测血糖（Glu）结果的偏差是否可以接受。方法参照CLSI《EP9-A2文件》的要求，以Olympus AU 640检测系统为目标检测系统（葡萄糖氧化酶法）、Vitros350检测系统为待评检测系统（干化学法）测定Glu，分别测定朗道质控物（水平2和水平3）各20次和新鲜血浆标本48份。结果新鲜血浆标本Glu测定经配对t检验检测系统间有统计学意义（P〈0．001），相关系数0.9988。两检测系统测定Glu的不精密度变异系数均小于3．3％，以检测系统1为目标检测系统，临床可接受性能评价检测系统2未超过T±5％范围。结论两个不同检测系统测定Glu结果存在偏倚，但具有可比性。

Objective To discuss the comparability of blood glucose （Glu） results with 2 detection systems. Methods Two different kinds of biochemistry detection systems were used to detect plasma Glu concenlrations at 2 levels of Randox quality controls and 48 clinical plas- ma according to EP9 - A2 file. The collected data were deal with statistics analysis. Results Paired statistics showed Glu results of patients plasma had significant difference between 2 detection systems （P 〈 0.001 ）. The correlation coefficient of 2 detection systems was 0.9988. The CV value of 2 detection systems was not excelled T ± 3.3% by precision assessment. Target system 1 was regarded as target detection system and evaluated the acceptability of detection system 2. As a result, detection system 2 was not excelled T ± 5% by clinic assessment. Conclusions The precision of Glu results in 2 kinds of detection systems accorded to clinic requirement.