应用西格玛度量和稳健算法评价不同检测系统糖化血红蛋白检测结果的可比性  

Comparability of glycated hemoglobin determination results with different determination systems using sigma metrics and robust algorithm

作　　者：康凤凤[1] 单志明[1] 宋超[1] 夏晓华[1] 陈倩 郦卫星[1] KANG Fengfeng;SHAN Zhiming;SONG Chao;XIA Xiaohua;CHEN Qian;LI Weixing(Zhejiang Center for Clinical Laboratory,Zhejiang Provincial People's Hospital,the People's Hospital of Hangzhou Medical College,Hangzhou 310014,Zhejiang,China)

机构地区：[1]浙江省临床检验中心浙江省人民医院杭州医学院附属人民医院

出　　处：《检验医学》2020年第2期168-172,共5页Laboratory Medicine

基　　金：浙江省医药卫生科技计划项目(2018KY009)

摘　　要：目的分析和评价浙江省糖化血红蛋白(HbA1c)项目的检测质量及不同系统检测结果的可比性。方法收集2018年浙江省HbA1c室间质量评价(EQA)数据,按照检测系统分组。以采用稳健算法计算的5个标本均值为靶值,并计算各组的稳健均值和实验室间的稳健变异系数(CV)。计算每个标本各分组的西格玛水平及加权西格玛水平。结果将268家实验室中纳入统计分析的实验室按检测系统分为4个组:A组(44家)、B组(87家)、C组(50家)、D组(26家)。5个标本的总体稳健CV依次为2.58%、1.85%、5.05%、2.70%和4.77%。A、B、C、D组的实验室间稳健CV分别为1.80%~3.16%、1.72%~2.64%、1.32%~1.81%、1.67%~3.38%,各组对应的西格玛平均值分别为1.19(-0.35~2.39)、2.42(1.66~3.25)、2.95(2.2~3.44)、0.26(-2.76~2.92)。仅C组有3个标本和B组有1个标本的西格玛水平>3。5个标本的加权西格玛水平分别为2.48、3.00、0.87、2.41和1.30,平均值为2。结论西格玛度量和稳健统计方法可更深入和客观地分析EQA结果中反馈的HBA1c检测质量水平。浙江省HbA1c检测质量水平尚不理想,需进一步采取质量管理措施,以实现检验结果互认的目标,满足临床诊断糖尿病的需求。Objective To evaluate the quality of glycated hemoglobin A1c(HbA1c) determination and the comparability between different determination systems. Methods The data of external quality assessment(EQA) of HbA1c in 2018 were collected. The participators were classified according to determination systems. The average of each specimen was calculated using robust algorithm as target value. The mean and inter-laboratory coefficient of variation(CV) of each group were calculated. The sigma metric of each group was calculated. The weighted sigma value was calculated for the specimens as well. Results Totally,268 laboratories took part in the program and reported results. A total of 4 groups were included for further analysis:group A(44 laboratories),group B(87 laboratories),group C(50 laboratories) and group D(26 laboratories). The overall robust CV of the 5 specimens were 2.58%,1.85%,5.05%,2.70% and 4.77%,respectively. The robust CV of group A-group D were 1.80%-3.16%,1.72%-2.64%,1.32%-1.81% and 1.67%-3.38%,respectively. The averages of sigma metric of group A-group D were 1.19(-0.35-2.39),2.42(1.66-3.25),2.95(2.20-3.44) and 0.26(-2.76-2.92). Three specimens in group C and one specimen in group B had a sigma metric >3. The weighted sigma metrics of the 5 specimens were 2.48,3.00,0.87,2.41 and 1.30,respectively. The average of the sigma level was 2. Conclusions The sigma metrics and robust algorithm can be used to evaluate the quality of HbA1c determination in EQA deeply and objectively. The quality of HbA1c determination in Zhejiang is not so satisfactory. Further step of quality management should be taken to achieve the goal of mutual recognition of determination results and meet the requirements for clinical diagnosis of diabetes mellitus.

关 键 词：糖化血红蛋白 糖尿病 六西格玛 室间质量评价 质量控制 

分 类 号：R446.1[医药卫生—诊断学]