Understanding the Use of Sigma Metrics in Hemoglobin A1c Analysis

Erna Lenters-Westra; Emma English

doi:10.1016/j.cll.2016.09.006

Understanding the Use of Sigma Metrics in Hemoglobin A1c Analysis

Clin Lab Med. 2017 Mar;37(1):57-71. doi: 10.1016/j.cll.2016.09.006. Epub 2016 Dec 14.

Authors

Erna Lenters-Westra¹, Emma English²

Affiliations

¹ 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.
² Faculty of Medicine and Health, School of Health Science, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, UK.

PMID: 28153370
DOI: 10.1016/j.cll.2016.09.006

Abstract

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.

Keywords: Analytical performance criteria; Diabetes; HbA1c; Sigma metrics.

Publication types

Review

MeSH terms

Diabetes Mellitus / diagnosis
Glycated Hemoglobin / analysis*
Hematologic Tests / methods
Hematologic Tests / standards
Humans
Point-of-Care Systems / standards
Quality Improvement
Reference Standards
Total Quality Management*

Substances

Glycated Hemoglobin A