我国七个血清酶检验项目检测质量分析

Quality assessment of seven kinds of sero-enzyme tests in China

目的评价中国丙氨酸转氨酶（ ALT）、天冬氨酸转氨酶（ AST）、γ－谷氨酰基转移酶（GGT）、乳酸脱氢酶（LDH）、肌酸激酶（CK）、α－淀粉酶（AMY）、碱性磷酸酶（ALP）等7项血清酶各检测系统的质量情况。方法现况调查。卫生部临检中心2013年生化EQA共15个批号样本及酶学正确度验证共3个批号样本的ALT、AST、GGT、LDH、CK、AMY、ALP回报数据，筛选出信息填报完整的1450家及165家参评实验室作为调查对象。将实验室检测系统分为进口配套系统（ AI）、国产配套系统（ AH）、进口试剂及相应配套校准品系统（ BI）、国产试剂及相应配套校准品系统（ BH）、除A、B类外采用进口校准品的非配套系统（ CI）与采用国产校准品的非配套系统（ CH）。计算7项血清酶的常规室间质评及正确度验证总误差、偏移、室内变异等参数，以生物学变异导出的最佳及适当指标作为评价标准，计算各检测系统内符合不同评价标准的实验室比例，以符合率＞85％为判定标准。结果6类常规检测系统中AI与CI类比例总和超过70％，CH类约为15％，其余系统不足10％。7项酶的正确度验证总误差均值范围6．2％～27．8％，常规室间质评总误差均值范围4．0％～7．0％，常规检测偏移绝对值均值范围4．2％～25．1％，室内变异均值范围3．6％～4．6％。分别以正确度验证总误差符合率、偏移符合率、室内变异符合率及常规室间质评总误差符合率评价各检测系统的准确度及其偏移与实验室室内不精密度，了解各检测系统间的可比性，结果为除ALP外其余6项酶的各检测系统具有可比性、除AMY、ALP 及系统AI 的GGT、LDH外其余各酶相应检测系统的准确度、除LDH、AMY、ALP及系统AI、CH的AST外其余各酶的室内不精密度均达适当标准，所有系统7项血清酶检测结果偏移未达适当标准。结论我国7项血清酶常规检测分析质量可基本满足临床需求。（中华检验医学杂志，2015，38：313－317）

Objective To evaluate the analytical quality of different analytical systems in measuring seven kinds of sero-enzymes consisting of Alanine Aminotransferase（ALT）, Aspartate Aminotransferase （AST）,γ-Glutamyltransferase（GGT）, Lactate Dehydrogenase（LDH）, Creatine Kinase（CK）, α-Amylase （AMY） and Alkaline Phosphatase（ALP）.Methods Data from 2013 routine chemistry external quality assessment （EQA） and Enzymes Trueness Verification（ETV） were collected.1 450 and 165 participating laboratories were selected respectively for investigation.Analytical systems of participating laboratories were classified into 6 kinds,i.e.imported matching system（AI）, domestic matching system（AH）, systems consisting of imported reagents and corresponding calibrators（BI）, systems consisting of domestic reagents and corresponding calibrators （ BH ） , unmatched systems using imported calibrators （ CI ） and unmatched systems using domestic calibrators （ CH ） .Total error, bias and coefficient of variation within laboratories （ CVI） were calculated from the data of 2013EQA and ETV The proportion of laboratories meeting the desirable and the optimal criteria derived from biology variation were analyzedby EXCEL2010 with coincidence rate （CR） above 85% as evaluation criterion.Results The AI and CI occupied more than 70%among six systems, CH occupied approximate 15% and the other systems were less than 10%.The 〈br〉 range of the average of ETV′s total errors , EQA′s total errors, absolute value of bias and CVI of seven kinds of sero-enzymes were 6.2%-27.8%, 4.0%-7.0%, 4.2%-25.1% and 3.6%-4.6% respectively. Accuracy, bias and within-laboratory imprecision were judged by CR of ETV′s total errors, ETV′s bias, CVI and EQA′s total errors respectively and comparability between different systems was evaluated.It turned out that the results of analytical systems of enzymes except ALP were comparable, the accuracy of systems of enzymes except AMY, ALP and GGT, LDH of AI, the within-laboratory imprecision of enzymes except LDH, AMY, ALP and AST of AI, CH could meet the desirable criteria.The bias of all systems of seven kinds of sero-enzymes were undesirable.Conclusions The analytical quality of routine testing of seven kinds of sero-enzymes could fulfill the clinical requirement generally in China.