Understanding the Use of Sigma Metrics in Hemoglobin A1c Analysis.
This study uses three unique data sets to show the state of the art of hemoglobin A1c (HbA1c) analyzers in a range of settings and compares their performance against the international guidance set by the International Federation of Clinical Chemistry and Laboratory Medicine task force for HbA1c standardization. The data are used to show the effect of tightening those criteria, and the study serves as a guide to the practical implementation of the sigma-metrics approach in a range of clinical settings.
Clinical Chemistry Department, Isala, Dr. Van Heesweg 2, Zwolle 8025 AB, The Netherlands; European Reference Laboratory for Glycohemoglobin, Isala, Dr. Van Heesweg 2, Zwolle 8025 AB, The Netherlands. Electronic address: w.b.lenters@isala.nl.
Erna
E
Lenters-Westra
Faculty of Medicine and Health, School of Health Science, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK.
Emma
E
English
D003920:Diabetes Mellitus / Q000175:diagnosis; D006442:Glycated Hemoglobin / Q000032:analysis*; D006403:Hematologic Tests / Q000379:methods / Q000592:standards; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards; D058996:Quality Improvement; D012015:Reference Standards; D017749:Total Quality Management
D006442:Glycated Hemoglobin
Analytical performance criteria; Diabetes; HbA1c; Sigma metrics