BACKGROUND: Standardization of hemoglobin (Hb)A 1c measurements is a process of considerable interest for quality assurance in diabetes management. To contribute to continuous quality improvement and fulfillment of the requirements for reference measurement procedures according to the standards of the International Organization for Standardization, we developed a calibration system of highest metrological order using isotope dilution-mass spectrometry with a reference material.
Background: Monitoring of hemoglobin A1c (HbA1c) is important in the management of diabetes. The IFCC reference measurement procedure for HbA1c is based on the ratio of glycated to nonglycated N-terminal hexapeptides of the β-chains of hemoglobin after digestion with Glu-C endoproteinase. We developed a modification of the original reference measurement procedure with HPLC-electrospray ionization/mass spectrometry (ESI/MS).
Method: We performed chromatographic separation of the hexapeptides using a C12 reversed-phase column and a binary gradient system consisting of a mixture of H2O/acetonitrile/formic acid.
Results: Using this method, we obtained higher signal intensities and improved system stability compared with the reference measurement procedure. In the range of 3% to 14% HbA1c, intralaboratory CVs were 0.71% to 1.86%. Deviations from IFCC target values were −0.87 to 1.00 relative %. These values fulfill acceptability criteria for HbA1c determination set by the IFCC Working Group on HbA1c Standardization.
Conclusions: This procedure for the determination of HbA1c improves the existing reference measurement procedure.
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