Error Grid Analysis (EGA) of Glycated Hemoglobin A1c: A Proposed Method

• Activity Number: 693
• Type: Contributed
• Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Jesse Canchola* and Shivani Aggarwal
• Companies: Roche Molecular Systems, Inc. and University of Southern California
• Keywords: Error Grid Analysis ; method comparison ; hemoglobin a1c

Abstract

Error Grid Analysis (EGA) uses graphical error grids for performance evaluations of medical devices or for comparing candidate and comparative measurement methodologies. Though not as widely used as we would like, EGA is an instructive and visually appealing performance evaluation methodology that shows the measurement of a new or improved test on the y-axis with a paired measurement of the reference test on the x-axis overlaid on a colorful grid of clinical regions (as established by experienced clinicians by consensus). Although error grids for glucose (mg/dL and mmol/l), hematocrit (%) and hemoglobin (g/dL) have been proposed, there is no known EGA for glycated hemoglobin A1c (HbA1c or, simply, A1c) in percent units at this time. We propose an EGA methodology for glycated hemoglobin A1c (%) using both the classical and modern methods.