目的 分析2006年度至2007年度连续2年参加国际临床化学联合会(IFCC)的参考实验室丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)的室间质评(RELA)结果及卫生部临床检验标准委员会(以下简称卫生部)的酶学室间比对结果,评估其所用测定参考方法的检测质量及其完善程度.方法 根据IFCC公布的ALT、AST、LDH的测定参考方法的标准操作程序(SOP)进行测定,根据<分析测量中不确定度的量化>(QUAM 2000)计算合成标准不确定度.用日本临床检验标准协议会(JCCLS)旭化成株式会社认证酶标准物质评估参考方法的分析性能(准确度与不精密度).结果 2006年度的国际RELA与卫生部酶学室间比对结果室内变异系数(CV)均在1.5%～2.1%,2007年度的国际RELA结果与卫生部酶学室间比对结果室内CV均在1.1%以下,且本实验室与总体均值的偏倚整体低于2006年度,除2006年度卫生部酶学室间比对结果有3个值与总体均值的偏倚(7.99%,-7.02%,-13.97%)超过允许偏倚外,其余值均在允许偏倚范围内.ALT、AST、LDH标准物质室内CV均在1%以下,且均值偏倚靶值均低于1%.结论 本实验室所用测定ALT、AST、LDH的参考方法已比较成熟稳定,2007年度的实验室比对结果优于2006年度.%Objective To analyze the results of three enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH)]in the ring trials of Reference Laboratories In Medicine (RELA) organized by International Federation of Clinical Chemistry(IFCC) and the ring trials organized by National Center for Clinical Laboratory (NCCL) in 2006 and 2007, and evaluate the analytic characteristic and reliability of the reference methods of ALT,AST and LDH. Methods ALT, AST, and LDH were measured by the standard operating procedure (SOP) of reference methods published by IFCC, and the combined standard uncertainty was calculated according to Quantifying Uncertainty in Analytical Measurement (QUAM) 2000. The analytic characteristic of the reference methods was evaluated by human enzyme calibrators of Asahi Kasei Pharma corporation from Japanese Committee for Clinical Laboratory Standards (JCCLS). Results The within-laboratory coefficient of variation (CV) of the three enzymes was ranged from 1.5%-2.1% in the 2006 ring trials of RELA organized by IFCC and NCCL, while the within-laboratory CV of the three enzymes was less than 1.1% in the 2007 ring trials, and the bias (%) was less than that in 2006. The values were within the deviation acceptance range except for the values of three samples(7.99% , -7.02%, - 13.97%). The within-laboratory CV of ALT, AST and LDH of the human enzyme calibrators of Asahi Kasei Pharma corporation were less than 1%, and the mean value deviation from target values was less than 1%. Conclusions The reference methods for the measurement of catalytic activity of ALT, AST and LDH have been improved and stable in our laboratory, and the results in the 2007 ring trials excelled those in the 2006 ring trials.
展开▼
