Investigation of 2 models to set and evaluate quality targets for Hb A1c: Biological variation and sigma-metrics

Weykamp, Cas, John, Garry, Gillery, Philippe, English, Emma ORCID: https://orcid.org/0000-0002-0480-6744, Ji, Linong, Lenters-Westra, Erna, Little, Randie R., Roglic, Gojka, Sacks, David B. and Takei, Izumi and IFCC Task Force on Implementation of HbA1c Standardization (2015) Investigation of 2 models to set and evaluate quality targets for Hb A1c: Biological variation and sigma-metrics. Clinical Chemistry, 61 (5). pp. 752-759. ISSN 0009-9147

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Abstract

BACKGROUND: A major objective of the IFCC Task Force on Implementation of HbA1c Standardization is to develop a model to define quality targets for glycated hemoglobin (Hb A1c). METHODS: Two generic models, biological variation and sigma-metrics, are investigated. We selected variables in the models for Hb A1c and used data of external quality assurance/proficiency testing programs to evaluate the suitability of the models to set and evaluate quality targets within and between laboratories. RESULTS: In the biological variation model, 48% of individual laboratories and none of the 26 instrument groups met the minimum performance criterion. In the sigma-metrics model, with a total allowable error (TAE) set at 5 mmol/mol (0.46% NGSP), 77% of the individual laboratories and 12 of 26 instrument groups met the 2σ criterion. CONCLUSIONS: The biological variation and sigma-metrics models were demonstrated to be suitable for setting and evaluating quality targets within and between laboratories. The sigma-metrics model is more flexible, as both the TAE and the risk of failure can be adjusted to the situation—for example, requirements related to diagnosis/monitoring or international authorities. With the aim of reaching (inter)national consensus on advice regarding quality targets for Hb A1c, the Task Force suggests the sigma-metrics model as the model of choice, with default values of 5 mmol/mol (0.46%) for TAE and risk levels of 2σ and 4σ for routine laboratories and laboratories performing clinical trials, respectively. These goals should serve as a starting point for discussion with international stakeholders in the field of diabetes.

Item Type:	Article
Uncontrolled Keywords:	sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School:	Faculty of Medicine and Health Sciences > School of Health Sciences
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Depositing User:	Pure Connector
Date Deposited:	05 Feb 2016 16:00
Last Modified:	24 Sep 2024 11:31
URI:	https://ueaeprints.uea.ac.uk/id/eprint/56979
DOI:	10.1373/clinchem.2014.235333

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