不同检测系统总胆固醇测定结果的偏倚分析

Bias analysis on TCHOL results among different kinds of detection system

目的:通过对不同检测系统进行方法对比分析,探讨各系统之间检测总胆固醇(TCHOL)结果是否具有可比性。方法:参照NCCLS《EP9-A文件》的要求,以可溯源的检测系统为目标检测系统,均采用酶法测定TCHOL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21次和测定新鲜血清标本40份。结果:朗道质控物和新鲜血清标本TCHOL测定经随机区组设计资料的方差分析,各检测系统间的差异均具有显著性(P<0.001)。各检测系统测定新鲜血清标本TCHOL可靠性系数α分别为0.9977、0.9990,各系统间的相关系数均大于0.975。各检测系统测定TCHOL的精密度CV均小于5%,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TCHOL均超出临床接受范围。结论:3个不同检测系统测定TCHOL结果不具有可比性,当同一实验室同一检验项目存在两个或两个以上检测系统时,应进行结果的对比和偏倚评估。

Objective Discuss the comparability of total cholesterol（TCHOL） results among different detection system. Methods 3 different kinds of biochemistry detection systems were used to detect TCHOL concentration in 2 levels of Randox quality controls and 40 clinical sera according to EP9-A file. The collected data were dealt with statistics analysis. Results Analysis of variance showed TCHOL results from different control and patients scra have significant difference in different detection system （P 〈 0. 001 ）. The correlation coefficient of each detection system were all above 0. 975 and the reliability coefficient of them was 0. 9977 and 0. 9990. Target system 1 was regarded as standard detection system and evaluated the acceptability of other detection system.. As a result, they were not accepted for TCHOL by clinic assessment. Conclusion The comparability of TCHOL results in 3 kinds of detection system did not accord to evaluation of clinical acceptability. If there are more than two systems for the same test, it is necessary to do method comparison and bias estimation in order to insure the comparability.