利用室间质评数据进行两种常见血细胞分析检测系统间检测结果互认的可行性分析  

A Feasibility Analysis of Mutual Recognition of Test Results BetweenTwo Common Blood Cell Analysis Detection Systems UsingInter-laboratory Quality Assessment Datasets

作　　者：彭红新 梅燕萍 王一杉 PENG Hongxin;MEI Yanping;WANG Yishan(Nanjing First Hospital,Nanjing Medical University,Nanjing Center for Clinical Laboratory,Nanjing 210006,China)

机构地区：[1]南京市第一医院,南京医科大学附属南京医院,南京市临床检验中心,江苏南京210006

出　　处：《标记免疫分析与临床》2024年第11期2066-2072,共7页Labeled Immunoassays and Clinical Medicine

基　　金：南京市重点学科建设单位(编号:JSDW202239)。

摘　　要：目的探讨南京市血细胞分析检测在两种主要检测系统间结果互认的可行性。方法对南京市2023年两次室间质量评价数据进行分析,应用SPSS 25.0对数据进行处理及统计学分析。结果2021~2023年南京地区血细胞分析室间质评参加单位逐年递增(2021年259家、2022年265家、2023年267家),不同等级医疗机构的血细胞分析室间质评合格率无统计学差异。迈瑞仪器组和Sysmex仪器组各批次样本WBC计数、RBC计数、Hgb和PLT计数项目中位数无明显差异,变异系数均在允许范围内,在Hct、MCV和MCH项目上,两仪器中位数也无明显差异,但变异系数未能全部达到行业标准要求,Sysmex仪器组明显优于迈瑞仪器组。对于MCHC项目,两仪器组除在中位数上存在差异外,变异系数未达标准。其他仪器组虽在中位数方面与迈瑞仪器组及Sysmex仪器组无显著差异,但其组内变异系数不符合行业标准。结论通过监测室间质评数据可作为血细胞分析检验结果互认监管的依据之一,南京市各医疗机构临床实验室检验结果互认WBC计数、RBC计数、Hgb和PLT计数4个项目在迈瑞仪器和Sysmex仪器上总体上具有较好的一致性,满足结果互认的要求,可暂不考虑迈瑞仪器和Sysmex仪器检测系统的差异。Objective To explore the feasibility of mutual recognition of blood cell analysis test results between two main detection systems using inter-laboratory quality assessment datasets from Nanjing city.Methods The inter-laboratory quality assessment datasets from two sessions in 2023 in Nanjing city were analyzed.SPSS 25.0 was applied for data processing and statistical analysis.Results The number of participants in the inter-laboratory quality assessment for blood cell analysis increased yearly:259 in 2021,265 in 2022,and 267 in 2023,with no statistically significant difference in the pass rate of inter-laboratory quality assessment among medical institutions of different grades.There was no significant difference in the median values of WBC count,RBC count,Hgb,and PLT count projects among the batches of samples from the Mindray group and the Sysmex group,and the coefficients of the variation were all within the allowable ranges.For Hct,MCV,and MCH projects,the median values of the two instruments also showed no significant difference,but the coefficients of the variation did not all meet the industry standard requirements,with the Sysmex instrument group outperforming the Mindray instrument group.For MCHC project,in addition to the difference for median values,the coefficients of the variation did not meet the standards.Although other instrument groups did not show significant differences in median values compared to the Mindray and Sysmex groups,their intra-group coefficients of the variation did not comply with industry standards.Conclusion Monitoring inter-laboratory quality assessment data can serve as one of the reference bases for the supervision of mutual recognition of blood cell analysis test results.The clinical laboratory test results of various medical institutions in Nanjing city are generally consistent for the four items of WBC count,RBC count,Hgb,and PLT count on both Mindray and Sysmex instruments,meeting the requirements for mutual recognition of results,while observed differences between the Min

关 键 词：室间质评 血细胞分析系统 可比性 一致性 检验结果互认 

分 类 号：R-331[医药卫生]