Inter-laboratory comparison of HbA1c can effectively improve test consistency of primary medical institutions

BackgroundGlycated hemoglobin (HbA1c) represents a diagnostic index and an important long-term measure for monitoring Diabetes mellitus (DM). In this study, we investigated the quality of HBA1c test in primary medical institutions, and conducted a comparison project of HBA1c test for two years, analyzed and evaluated the test consistency of HBA1c. MethodsA cohort study was conducted by Wuhan Center for Clinical Laboratory, involving 51 primary medical institutions and 29 tier-three hospitals. Fresh frozen blood samples were prepared by a clinical laboratory certificated by the National Glycohemoglobin Standardization Program (NGSP), and distributed to 80 participating institutions every three months. Microsoft Excel 2021 software was employed to analyze the mean, standard deviation and coefficient of variation of the test results. ResultsResults showed that 60.8% HBA1c test results cannot reach the quality requirements of HbA1c measurement (CV<3.5%) in primary medical institutions. After executing the project, the laboratory pass rate of HBA1c test increased from 39.2% to 64.6%, and the maximum coefficient of variation (CV) within the immunological assays of HBA1c test dropped from 18.0% to 11.4%. ConclusionsInter-laboratory comparison of HbA1c can effectively improve test consistency of primary medical institutions. The finding has implications for diabetes management strategies, emphasizing the importance of continuous comparison of HBA1c test in primary medical institutions, providing a practical example to accelerate the mutual recognition of medical test results in a wider range.