System accuracy evaluation for blood glucose measurements should be performed in accordance with ISO 15197:2003 and CLSI-approved guideline EP7-A2

摘要

Warner et al. recently reported potential risks to patient welfare with the use of bedside rather than laboratory blood glucose (bG) measurement on bG meters such as the Accu-Chek~R Performa (Roche Diagnostics, Mannheim, Germany). Warner et al. are claiming that this bG meter potentially fails to diagnose hypoglycemia and might lead to overtreatment of hyperglycemia in patients with high blood maltose concentrations and high hematocrit values. Our review of their methods identified several key discrepancies that may help to explain their conclusions.First, the manufacturer's recommended comparison method of the Accu-Chek Performa bG meter is the hexokinase method with deproteinization of capillary whole blood samples. This hexokinase method is directly calibrated to the reference measurement procedure isotope dilution gas chromatography/ mass spectrometry (ID-GC/MS), which is a reference procedure recommended by the Joint Committee for Traceability in Laboratory Medicine (JCTLM)2 (JCTLM DB identification number: C3RMMP19, isotope dilution mass spectrometry method for glucose in whole blood).