Abstract:

Objective To improve the harmonization of glycated hemoglobin A_1c（HbA_1c）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 HbA_1c determination. The results reported by each participating laboratory were obtained and analyzed. The passing rates and the inter-laboratory 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 HbA_1c 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 HbA_1c determination has been enhanced,which would further promote the harmonization and standardization process of HbA_1c determination in Wuhan.

Key words: Glycated hemoglobin A_1c, Harmonization, Diabetes mellitus