不同检测系统测定丙氨酸氨基转移酶结果的可比性研究

目的探讨不同检测系统丙氨酸氨基转移酶(ALT)测定结果的可比性。方法分别在3个检测系统酶法测定ALT朗道质控物(水平2和水平3)各20次和新鲜血清标本45份。结果朗道质控物和新鲜血清标本ALT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)。各检测系统新鲜血清标本ALT测定可靠性系数α为0.9981,各系统间的相关系数均大于0.975。各检测系统测定ALT的精密度变异系数均小于6.7%,以可溯源的检测系统1为目标检测系统,临床接受性能评价中检测系统2未超过而检测系统3超过T±10%允许范围。结论3个检测系统测定ALT结果的精密度符合临床要求,临床接受性能评价中检测系统3无可比性,需采取纠正措施,实现可比性。

Comparable research on alanine aminotransferase results among different kinds of detection system

Objective To study the comparability of alanine aminotransferase (ALT) results among different detection systems. Methods Three different kinds of biochemistry detection system, with enzyme method, were used to detect ALT concentrations in 2 kinds of Randox quality controls (level 2 and level 3) and 45 serum specimens. The collected data were dealt with statistical analysis. Results Analysis of variance showed the ALT results from different control and patients sera had significant difference in different detection systems (P<0.001). The correlation coefficient of each detection system was above 0.975 and the reliability coefficient of them were close to 1. We regarded detection system 1 as target detection system and evaluated the acceptability of other detection systems. As a result, detection system 2 was accepted and detection system 3 was partly accepted by clinic assessment. Conclusions The precision of ALT results in the 3 kinds of detection systems accords with clinical requirement. Comparability exists in the evaluation of clinical acceptability except detection system 3.