Modified HPLC–ESI–MS Method for Glycated Hemoglobin Quantification Based on the IFCC Reference Measurement Procedure and Its Application for Quantitative Analyses in Clinical Laboratories of China

摘要

BackgroundThe level of glycated hemoglobin (HbAsub1c/sub) has been recognized as an important indicator of long-term glycemic control. However, the HbAsub1c/sub 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 HbAsub1c/sub measurements in China. MethodsThe HbAsub1c/sub concentration was measured using a modified high-performance liquid chromatography–electrospray 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 HbAsub1c/sub 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. ResultsThe linearity, reliability, and accuracy of the modified HPLC–ESI–MS method with a shortened running time of 6 min were successfully validated. Out of 89 hospitals evaluated, the relative biases of HbAsub1c/sub concentrations were 1c/sub concentrations determined by HPLC methods were similar to the values obtained from the current HPLC–ESI–MS method. ConclusionThe HPLC–ESI–MS method represents an improvement over existing methods and provides a simple, stable, and rapid HbAsub1c/sub measurement with strong signal intensities and reduced ion suppression.