上海市徐汇区HbA_(1c)检测一致性计划的建立和初步评价

Establishment and preliminary evaluation of HbA_(1c) determination harmonization plan of Xuhui District of Shanghai

目的建立上海市徐汇区糖化血红蛋白(HbA_(1c))检测一致性计划,提高徐汇区社区卫生服务中心HbA_(1c)检测结果的一致性。方法由徐汇区HbA_(1c)检测一致性计划的牵头单位上海市第八人民医院定期制备新鲜混合全血样本,由获得美国国家糖化血红蛋白标准化计划(NGSP)二级参考实验室资格认证的复旦大学附属中山医院检验科确定靶值,分发到参加徐汇区HbA_(1c)检测一致性计划的9家社区卫生服务中心临床实验室,由各临床实验室采用高效液相色谱法(HPLC)检测HbA_(1c)。对包括牵头单位在内的10家临床实验室的检测结果进行比对,分析HbA_(1c)检测结果的通过率、偏移、室间变异系数(CV)。结果共发放5次比对样本。10家临床实验室5次比对的通过率分别为100%、10%、100%、100%、50%,偏移范围分别为-4.44%~5.53%、-10.39%~3.39%、-5.00%~7.41%、-4.44%~4.65%、-5.13%~10.91%,CV分别为1.26%~2.71%、1.20%~4.07%、0.89%~3.36%、0.63%~1.90%、2.14%~3.62%。结论通过参加徐汇区HbA_(1c)检测一致性计划,各社区卫生服务中心临床实验室HbA_(1c)检测结果的一致性明显提高。

Objective To establish the harmonization plan of glycated hemoglobin A_(1c)(HbA_(1c))determination in Xuhui District of Shanghai,and to improve the consistency of HbA_(1c) determination results in Xuhui community healthcare centers.Methods Shanghai Eighth People's Hospital,the leading unit of the HbA_(1c) determination harmonization plan in Xuhui District,regularly prepared fresh mixed whole blood samples.The target values were determined by the laboratory of Zhongshan Hospital affiliated to Fudan University,which was certified as the second level reference laboratory of the National Glycohemoglobin Standardization Program(NGSP).The samples were distributed to the 9 laboratories of community healthcare centers participating in the HbA_(1c) determination harmonization plan in Xuhui District.HbA_(1c) was determined by high-performance liquid chromatography(HPLC)in each laboratory.The results of 10 laboratories,including the leading unit,were compared,and the pass rate,deviation and coefficient of variation(CV)of HbA_(1c) determination results were analyzed.Results A total of 5 batches of comparison samples were distributed.The pass rates of 5 comparisons in 10 laboratories were 100%,10%,100%,100%and 50%,respectively.The bias ranges were-4.44%-5.53%,-10.39%-3.39%,-5.00%-7.41%,-4.44%-4.65%and-5.13%-10.91%,and the CV were 1.26%-2.71%,1.20%-4.07%,0.89%-3.36%,0.63%-1.90%and 2.14%-3.62%,respectively.Conclusions By participating in the HbA_(1c) determination harmonization plan of Xuhui District,the consistency of HbA_(1c) determination results in the laboratories of community healthcare centers has been improved.