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Diabetes mellitus is a serious health problem in the United States, and much of the morbidity and mortality associated with diabetes mellitus can be ameliorated by proper blood glucose control (1). Consequently, serious effort has been put forth to increase the accurate and timely monitoring of blood glucose concentrations. Hemoglobin A1c (HbA1c) is a biomarker that provides a snapshot of long-term glucose control in diabetes. The Core Laboratory for Clinical Studies at Washington University School of Medicine is a Secondary Reference Laboratory (SRL no. 4) of the National Glycohemoglobin Standardization Program (NGSP) (2). We routinely measure HbA1c percentages from whole blood samples by the HbA1c Tina-quant® II method (Roche Diagnostics Corporation) on a Roche Hitachi 917 Analyzer. The Tina-quant II HbA1c assay is an NGSP-certified method (3) that quantifies the total hemoglobin mass (g/dL) spectrophotometrically and the …

Correction of Positive Bias of the Roche Tina-quant II Hemoglobin A1c (HbA1c) Assay at Low HbA1c Percentages