科研之友
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摘要
Background: The level of glycated hemoglobin (HbA(1c)) has been recognized as an important indicator of long-term glycemic control. However, the HbA(1c) measurement is not currently included as a diagnostic determinant in China. Current study aims to assess a candidate modified International Federation of Clinical Chemistry reference method for the forthcoming standardization of HbA(1c) measurements in China. Methods: The HbA(1c) concentration was measured using a modified high-performance liquid chromatographyelectrospray ionization-mass spectrometry (HPLC-ESI-MS) method. The modified method replaces the propylcyanide column with a C18 reversed-phase column, which has a lower cost and is more commonly used in China, and uses 0.1% (26.5 mmol/l) formic acid instead of trifluoroacetic acid. Moreover, in order to minimize matrix interference and reduce the running time, a solid-phase extraction was employed. The discrepancies between HbA(1c) measurements using conventional methods and the HPLC-ESI-MS method were clarified in clinical samples from healthy people and diabetic patients. Corresponding samples were distributed to 89 hospitals in Beijing for external quality assessment. Results: The linearity, reliability, and accuracy of themodified HPLC-ESI-MSmethod with a shortened running time of 6 min were successfully validated. Out of 89 hospitals evaluated, the relative biases of HbA(1c) concentrations were < 8% for 74 hospitals and < 5% for 60 hospitals. Compared with other conventional methods, HbA(1c) concentrations determined by HPLC methods were similar to the values obtained from the current HPLC-ESI-MS method. Conclusion: The HPLC-ESI-MS method represents an improvement over existing methods and provides a simple, stable, and rapid HbA(1c) measurement with strong signal intensities and reduced ion suppression.
- 出版日期2016-9
- 单位首都医科大学; 中医学科学院; 中国中医科学院眼科医院
