两个糖化血红蛋白分析系统测量不确定度的评定和比较  

An Evaluation and Comparison of Measurement Uncertainty Between Two Analytic Systems of Glycated Hemoglobin

作　　者：何春容[1] 陈欣 范超 杨清[1] HE Chunrong;CHEN Xin;FAN Chao;YANG Qing(Department of Clinical Laboratory,Chengdu Third People’s Hospital,Chengdu 610031,China;Department of Medical Laboratory Science,Southwest Medical University,Luzhou 646000,China)

机构地区：[1]成都市第三人民医院检验科,四川成都610031 [2]西南医科大学医学检验系,四川泸州646000

出　　处：《标记免疫分析与临床》2022年第11期1952-1956,共5页Labeled Immunoassays and Clinical Medicine

基　　金：四川省中医药管理局课题(编号:2020CP0003)。

摘　　要：目的探讨测量不确定度评定在糖化血红蛋白检测中的应用。方法收集2021年1月至2021年12月成都市第三人民医院两个糖化血红蛋白检测系统日本东曹HLC-723G8和深圳普门H9测定糖化血红蛋白(HbA1c)的室内质控数据,同时收集这两个系统参加国家卫生健康委2021年至2022年两次室间质评的回报结果,依据Nordtest准则评定HbA1c的标准不确定度和扩展不确定度,进而与行业标准《YY/T1246-2014糖化血红蛋白分析仪》中提到的分析目标进行比较。结果日本东曹HLC-723G8检测系统在质控水平1的扩展不确定度(k=2)为6.78%,在质控水平2的扩展不确定度(k=2)为6.25%;深圳普门H9检测系统在质控水平1的扩展不确定度(k=2)为7.39%,在质控水平2的扩展不确定度(k=2)为7.00%。结论日本东曹HLC-723G8和深圳普门H9两个检测系统两个水平的扩展不确定度(k=2)均达标(<8%)。在构成不确定度的分量中偏倚引入的不确定度在两个系统中均占比较大,还需要进一步改进。Objective To explore the application of measurement uncertainty assessment in the detection of glycosylated hemoglobin.Methods The internal quality control data of two HbA1c detection systems:Dongcao HLC-723G8(Japan)and Pumen H9(Shenzhen),in The Third People’s Hospital of Chengdu from January,2021 to December,2021 were collected,and the returned results of the two systems participating in the external quality assessment conducted by the National Health Commission from 2021 to 2022 were also collected.Standard uncertainty and extended uncertainty of HbA1c were evaluated according to Nordtest Criteria,and then compared with the analytic objectives mentioned in the standard《YY/T1246-2014 HbA1c Analyzer》.Results The extended uncertainty(k=2)of HLC-723G8 testing system from Japan was 6.78%at the quality control level 1 and 6.25%at the quality control level 2.The extended uncertainty(k=2)of Shenzhen Pumen H9 detection system at quality control level 1 was 7.39%,and the extended uncertainty(k=2)at quality control level 2 was 7.00%.Conclusion The extended uncertainty(k=2)of the two detection systems,Dongcao HLC-723G8 and Shenzhen Pumen H9,can reach the expected standard(<8%).For the components of uncertainty,the uncertainty introduced by bias accounts for a large proportion in both systems,which needs further improvement.

关 键 词：测量不确定度 糖化血红蛋白 Nordtest准则 室内质控 室间质评 

分 类 号：R-331[医药卫生]