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武汉地区糖化血红蛋白一致性计划的建立和评价

Establishment and evaluation of Wuhan Glycohemoglobin Harmonization Program

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【作者】 岳道远陈薇廖庆余微婷李辉军

【Author】 YUE Daoyuan;CHEN Wei;LIAO Qing;YU Weiting;LI Huijun;Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology;Department of Clinical Laboratory,Zhongnan Hospital,Wuhan University;

【通讯作者】 李辉军;

【机构】 华中科技大学同济医学院附属同济医院检验科武汉大学中南医院检验科

【摘要】 目的建立武汉地区糖化血红蛋白检测一致性计划(WHGHP),提高武汉地区各实验室间糖化血红蛋白(HbA1c)检测结果的一致性。方法通过调查问卷方式征集武汉地区自愿参加WHGHP的实验室。由3家有着良好检测质量保证的实验室组成HbA1c定值实验室,对比对样本进行定值后,向其他参加WHGHP的实验室发放。统计各实验室的上报数据,计算2018年和2019年WHGHP的通过率和室间变异系数(CV)。选取2019年4个季度HbA1c靶值为5.5%~6.0%的比对样本,统计各方法组内均值与偏移情况。结果参加WHGHP的实验室由2018年的23家增加到2019年的43家,参加实验室的通过率由2018年的81.8%~82.6%提升到2019年的83.7%~90.7%,WHGHP室间最大CV由7.9%降至3.6%,逐步接近美国病理学家协会(CAP)、美国国家糖化血红蛋白标准化计划(NGSP)、国家卫生健康委临床检验中心(NCCL)的HbA1c室间CV。2019年4个季度中,第2季度各方法组内的偏移较大,最大CV达10.2%;第4季度的最大CV降至3.1%。结论 WHGHP的建立和实施提高了参加实验室的HbA1c检测质量,推动了武汉地区HbA1c检测的一致性和标准化进程。

【Abstract】 Objective To improve the harmonization of glycated hemoglobin A1c(HbA1c)measurements among the clinical laboratories in Wuhan of China by establishing Wuhan Glycohemoglobin Harmonization Program(WHGHP). Methods Laboratories were voluntarily enrolled in WHGHP through questionnaires.Three laboratories with good quality assurance constituted a core reference network to determine the target values of comparison samples. These samples were then assigned to the participating laboratories for HbA1c determination.The results reported by each participating laboratory were obtained and analyzed. The passing rates and the interlaboratory coefficients of variation(CV) in 2018 and 2019 were estimated. The mean values and deviations of each method group were calculated based on the measurements of samples with HbA1c target values from 5.5% to 6.0% in 2019. Results The number of laboratories participating in WHGHP increased from 23 in 2018 to 43 in 2019. The passing rates of all the participating laboratories increased from 81.8%-82.6% in 2018 to 83.7%-90.7% in 2019,and the maximum imprecisions(CV) were decreased from 7.9% to 3.6%,which were getting close to the results from the College of American Pathologists(CAP),the National Glycohemoglobin Standardization Program(NGSP) and the National Center for Clinical Laboratories(NCCL). Among the 4 quarters of 2019,the biggest deviation within each method group was found in the second quarter,and the maximum CV was 10.2%. Among the 4 quarters of 2019,the maximum CV fell to 3.1%. Conclusions Based on the establishment and implementation of WHGHP,the quality of HbA1c determination has been enhanced,which would further promote the harmonization and standardization process of HbA1c determination in Wuhan.

  • 【文献出处】 检验医学 ,Laboratory Medicine , 编辑部邮箱 ,2022年01期
  • 【分类号】R587.1
  • 【下载频次】58
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