Abstract:

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.

Key words: Glycated hemoglobin, Harmonization, Diabetes mellitus