国际酶学参考实验室室间比对四种酶学项目结果分析

摘要

Objective To reflect the capability of the Chinese reference laboratories through the assessment and analysis of the uniformity and uncertainty for GGT , LDH, ALT and AST among RELA from 2006 to 2011.Methods To collect the measurement results and the combined measurement uncertainties of all laboratories that had participated in RELA during 2006 and 2011.The testing results and uncertainties of the four enzymes among RELA were grouping analyzed.They were divided into four groups:the whole group ( all laboratories , 12-27 labs annual ) , the foreign group ( laboratories except for the Chinese laboratories , 4-10 labs annual ) , the Chinese group ( all Chinese laboratories , 6-18 labs annual ) and the reference group ( LAB 3 ).Calculate the CVs of inner-group measurement results , the bias of the Chinese group and the reference group measurement results to the foreign group and the elative standard measurement uncertainties , and evaluate the uniformity of measurement results and the ur variation trends.Results There were annual downtrend for coefficient of variation except LDH.Except ALT in 2006, CVs of the foreign group , the Chinese group and the whole group were all below 5%.The Chinese group had 87.5%(42/48) smaller CV than the foreign group in the last 6 years.The biases of the Chinese group to the foreign group were from-2%to 2%except GGT and ALT in 2006 and ALT in 2008.The Chinese group had 66.7% results less than the foreign group during 2006 and 2011.There was significant differences between the Chinese group measurement results ( 3.525 μkat/L ) and the foreign group ( 3.647 μkat/L ) of ALT high batch in 2008 (T=2.635,P<0.05).The relative standard measurement uncertainties of the four groups had the same uptrend and the low batch was 10% higher than the high batch.The reference group had a stable ur of 1.2%.The Chinese group had a lower ur than the foreign group during 2007 and 2009, but had similar levels after 2010.The Chinese group had constant relative standard uncertainties of 1.0% in 2009, 2010 and 2011.Conclusions There was no significant differences between the Chinese group and the foreign group, and they had good uniformity .The results of the relative standard measurement uncertainty were objective and stable.%目的：评估和分析中国酶学参考实验室参加国际临床化学委员会（ IFCC ）组织的参考实验室室间比对（ RELA）中γ-谷氨酰转移酶（ GGT）、乳酸脱氢酶（ LDH）、丙氨酸氨基转移酶（ ALT）及天冬氨酸氨基转移酶（ AST）的测定一致性及不确定度，反映中国参考实验室检测能力。方法收集2006年至2011年RELA结果发布网站上的所有参与GGT、LDH、ALT及AST比对实验室的测定值及合成不确定度，分为全体组（所有实验室，12～27家/年）、国外组（除中国实验室外的实验室，4～10家/年）、中国组（中国实验室，6～18家/年）和参考组（ Lab3， Gerhard Schumann ）四组，分年度及样品值高低水平统计分析，计算组内测定值的变异系数（ CV）、中国组及参考组测定值对国外组的偏倚及各组相对标准不确定度（ur），评价国内外实验室四种酶学项目RELA结果一致性以及ur 的变化趋势。结果各实验组四种酶高低两个水平样品CV值变化趋势一致，除LDH外，各组各项目高低两个水平样品CV值总体呈随年度递减趋势；全体组、国外组及中国组三组各项目测定值组内CV值除2006年ALT结果外，均在5％之内；六年的组内CV值数据中，中国组有87.5％（42/48）的情况低于国外组。除2006年GGT、ALT结果及2008年ALT结果外，中国组对国外组偏倚均在-2％～2％之间；2006年至2011年，中国组实验室测定值有75.0％（36/48）的结果低于国外组。2008年ALT高水平测定值均值中国组3.525μkat/L 低于国外组3.647μkat/L，差异有统计学意义（ T ＝2.635， P ＜0.05）。各实验组四种酶高低两个水平批次的ur 均呈上升趋势，各年度各实验组低水平均较高水平值高约10％。参考组ur稳定在1.2％，中国组在2007年至2009年ur低于国外组；中国组实验室在2009、2010、2011三年ur稳定在1.0％。结论中国参考实验室酶学项目测定值与国外实验室无统计学差异，参考实验室间一致性较好，相对标准不确定度结果客观且稳定。