北京市肿瘤标志物检测室间质量评价三年回顾分析

A Retrospective Analysis of Tumor Markers’External Quality AssessmentResults in Beijing During the Past Three Years

目的通过回顾2018年至2020年北京市肿瘤标志物室间质量评价(EQA)的结果,分析北京市范围内医学实验室肿瘤标志物的检测现况。方法每年通过统一配送的方式将10个批号的肿瘤标志物质评物质一次性发放到各参加实验室,每次测定5个批号,然后实验室将其检测结果回报给北京市临床检验中心。对2018年至2020年3年的EQA结果进行统计,分析参加实验室情况,按检测系统进行分组,剔除离群值,以ISO13528方法计算的稳健平均值为靶值,分别计算各组变异系数(CV)等指标,并对由生物学变异推导出的允许不精密度质量规范的应用进行探讨。结果2018年至2020年的北京市参加肿瘤标志物项目EQA的实验室数目分别为252家、287家和305家,合格实验室数目分别为86.90%、91.67%和92.47%,多数检测项目的合格率和优秀率逐年升高。进口和国产检测系统的组内平均CV均在10%以内。根据生物学变异度导出的允许不精密度质量规范,除CA15-3外,其余所有项目检测系统的组内CV都达到最低的质量规范。CA15-3在三级医院的检测系统的组内CV可达到最低质量规范,而二级和一级医院则未达到。结论北京市肿瘤标志物项目EQA活动有力提升了北京市范围内该项目整体检测水平。

Objective To obtain the status of tumor markers determination in medical laboratories in Beijing by analyzing external quality assessment(EQA)results from 2018 to 2020.Methods Ten batches of quality control samples of tumor makers were sent to laboratories at one time from subjects who participated the EQA program each year,and five samples were determined each time by the routine methods in laboratory.Then laboratories returned their results to Beijing Center for Clinical Laboratories(BCCL).The data were grouped by the detection system and analyzed by BCCL from 2018 to 2020.After outliers were removed,the coefficient of variation(CV)in each group was calculated by ISO13528 robust statistical method with the robust mean as the target value.The application of allowable imprecision derived from biological variation in EQA of each tumor marker was evaluated.Results There were 252,287 and 305 laboratories who participated EQA of tumor markers from 2018 to 2020,respectively,and the number of qualified laboratories accounted for 86.90%,91.67%and 92.47%,respectively.Passing rate and excellent rate of most markers were increased by years.Within-group CVs were lower than 10%both in imported and in domestic detection systems.According to allowable imprecision derived from biological variation,all CVs within group could achieve the minimum allowable imprecision except CAl5-3.However,CVs within group of CA15-3 could achieve the minimum allowable imprecision in tertiary hospitals,and still not able to achieve it in primary and secondary hospitals.Conclusion EQA of tumor markers by BCCL is useful and can improve the quality of tumor markers measurement.