2011年湖南省肿瘤标志物项目检测室间质量评价

Analysis of External Quality Assessment Results of Tumor Markers Detection in Hunan Province in 2011

目的讨论影响肿瘤标志物(tumor markers,TM)项目检测室间质量评价(EQA)结果准确性的影响因素。方法对2011年TM项目检测的EQA回报数据进行统计分析。结果 2011年TM项目EQA参评实验室合格率为74.3%;各项目检测试剂分组数据和方法学分组数据平均CV值均值大部分高于NACB的最新指南建议值(批间CV<10%)。经无重复双因素方差分析,不同方法分组各项目统计结果合格率及CV值的组间差异有统计学意义(P<0.05),不同试剂分组的CV值差异亦有统计学意义(P<0.05)。结论本省TM EQA参评实验室过少,EQA样本的靶值代表性待提高;实验室选择的检测系统不一致是TM项目EQA的检测结果的及格率和PT得分不理想的原因;分组测定EQA结果以电化学发光组准确度最好,试剂分组以进口试剂EQA结果精密度较好。

Objective To assess the analytical performances of the laboratories in Hunan Province by evaluating the accuracy of external quality assessment（EQA） results of tumor markers（TMs） detection and explore the influencing factors.Methods EQA data of tumor markers reported from various participant laboratories in Hunan Province in 2011 were statistically analyzed.Results In 2011,the qualified rate of TMs EQA in participant laboratories was 74.3%.The average CVs of TMs EQA results when grouped by detection reagents or by methodology were higher than the suggested values in the latest guide of NACB（inter-run CV10%）.Grouped by methodology,the qualified rates and CV values of all TMs items were significantly different（P0.05）,so were the CV values of TMs when grouped by detection reagents.Conclusions The laboratories that participated in TMs EQA in Hunan Provicne in 2011 are few.The representativeness of target values of EQA samples waits for being improved.Inconsistent detection systems in various laboratories may be the main reason for the non-ideal pass rate and proficiency testing（PT） scores.The accuracy of electrochemiluminescence method is the best.The precision of imported reagents is better than domestic ones.