不同检测系统淀粉酶测定结果的偏倚分析

Bias Estimation on Amylase Results Among Different Kinds of Analysis Systems

目的探讨3个不同检测系统间淀粉酶(AMY)测定结果是否具有可比性。方法参照NCCLS《EP9-A文件》的要求,分别在3个不同的干化学检测系统(JohnsonVitros250,JohnsonDT-60和JohnsonVitros250仪器及其配套的校准物、质控物和试剂等,分别命名为检测系统1～3)测定RANDOX质控物(水平2和水平3)各20次和40例不同浓度患者新鲜血清AMY浓度,并对结果进行统计分析。结果不同检测系统质控物和新鲜血清标本AMY测定以秩和检验或方差分析,各检测系统间的总体差异均有显著性(P<0.01)。各检测系统测定新鲜血清标本AMY可靠性系数α为0.9821,各系统间的相关系数均大于0.975。各检测系统测定AMY的精密度变异系数值均小于10%,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检测系统2和3检测结果均超过T±15范围。结论3个不同检测系统测定AMY结果不具可比性,应对其实施整改措施,使结果具有可比性。

Objective Discuss the comparability of amylase（AMY） results among different analysis. Methods 3 different kinds of dry chemistry analysis systems were used to analyse AMY concentration in 2 levels of Randox quality controls and 40clinical sera accolrding to EP9-A file. The clollected data were deal with statistics analysis. Results Analysis of wariance showed AMY results from different control and patients sera have significant difference in different analysis system（P〈0. 01）.The correlation coefficient of each analysis system was above 0.975 and the reliability coefficient of them was 0.9821. Analysis system 1 was regarded as target analysis system and evaluated the acceptability of other analysis systems. As a result, analysis system 2 and analysis system 3 were not accepted by clinic assessment. Conclusions The precision of AMY results in the 3kinds of analysis systems accorded to clinic requirement. However, comparability did not exist according to the clinical acceptability evaluation.