全国肿瘤标志物不同检测系统质量水平分析

目的分析我国肿瘤标志物检测的实验室内精密度和实验室间变异,了解不同检测系统的质量水平。方法提取卫生部临床检验中心近3年的室间质量评价(EQA)数据,按检测系统对各实验室的测定结果进行分组,剔除"均值±3s"以外的数据,计算各组的变异系数(CV)。通过基于Web方式的EQA软件系统收集参加全国肿瘤标志物EQA实验室2012年5月份在控的室内质控数据及其CV,并分别以美国临床实验室改进修正法案(CLIA'88)1/3允许总误差(TEa)、1/4 TEa以及按照生物学变异推导的最低、适当和最佳允许不精密度评价标准作为判断标准,计算不同系统的通过率。结果按分析系统分组后,其中有4个进口系统各项平均CV10%;而放射免疫分析(RIA)组和酶联免疫吸附试验(ELISA)组各项目显示较大的CV。多数系统70%以上的实验室室内精密度满足1/3 TEa要求,多数检测系统85%以上的实验室能够满足基于生物学变异度的适当规范要求。结论在实验室使用的分析系统中,进口系统2室间精密度最好,进口系统5室内精密度最好。生产厂家和学术机构应关注肿瘤标志物检测的溯源性问题,临床实验室应加强质量控制,以保证测定结果的可靠性。

Analysis on the quality levels of national tumor markers among different measuring systems

Objective To analyze intralaboratory precisions and interlaboratory variations of the measuring system for national tumor marker detection,and to investigate the quality levels among different measuring systems.Methods External quality assessment（EQA）data were collected from the National Center for Clinical Laboratory in the past 3 years.The measuring results were classified into different groups according to the measuring systems,after excluding the data of＂mean ±3s＂.The coefficients of variation （CV）were calculated respectively.Internal quality control data and corresponding CV from nationwide participanting laboratories in May 2012 were collected by Web-based EQA software system.Acceptable rates were calculated according to Clinical Laboratory Improvement Amendments（CLIA）′88 1/3 total allowable error （TEa ）,1/4 TEa and the specifications based on biological variation including the minimal, appropriate and optimal imprecisions.Results After classification based on analysis systems,the average CVs of 4 inlet systems were 〈10%.However,from the groups of radioimmunoassay （RIA）and enzyme-linked immunosorbent assay （ELISA）showed large CV.More than 70% of laboratories from most systems met 1/3 TEa requirement.More than 85% of laboratories from most systems met appropriate specification based on biological variation.Conclusions The inlet system 2 shows best interlaboratory precision,and inlet system 5 shows best intralaboratory precision.To ensure the reliability of the measuring results,manufacturers and academic institutions should pay more attention to the traceability of tumor markers,meanwhile clinical laboratories should strengthen their quality controls.