Investigation of 2 Models to Set and Evaluate Quality Targets for Hb A1c: Biological Variation and Sigma-Metrics

Author:

Weykamp Cas12,John Garry3,Gillery Philippe4,English Emma5,Ji Linong6,Lenters-Westra Erna78,Little Randie R9,Roglic Gojka10,Sacks David B11,Takei Izumi12

Affiliation:

1. Department of Clinical Chemistry and

2. European Reference Laboratory, Location Queen Beatrix Hospital, Winterswijk, the Netherlands

3. Norfolk and Norwich University Hospital, Norwich, UK

4. Laboratory of Pediatric Biology and Research, University Hospital of Reims, Reims, France

5. School of Medicine, University of Nottingham, Royal Derby Hospital Site, Derby, UK

6. Peking University People's Hospital, Beijing, China

7. Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands

8. European Reference Laboratory, Location Isala, Zwolle, the Netherlands

9. Departments of Pathology and Child Health, University of Missouri School of Medicine, Columbia, MO

10. Department of Management of Noncommunicable Diseases, World Health Organization, Geneva, Switzerland

11. Department of Laboratory Medicine, NIH, Bethesda, MD

12. Diabetes and Endocrine Department, Ichikawa General Hospital, Ichikawa, Japan

Abstract

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.

Funder

NIH

Publisher

Oxford University Press (OUP)

Subject

Biochemistry (medical),Clinical Biochemistry

Reference23 articles.

1. Task Force on Implementation of HbA1c Standardization (Integrated Project) (TF-HbA1c). www.ifcc.org/executive-board-and-council/eb-task-forces/task-force-hba1c (Accessed April 2015).

2. Criteria for judging precision and accuracy in method development and evaluation;Westgard;Clin Chem,1974

3. Proposal for setting generally applicable quality goals solely based on biology;Fraser;Ann Clin Biochem,1997

4. Defining acceptable limits for the metrological traceability of specific measurands;Bais;Clin Chem Lab Med,2013

5. Westgard JO , WestgardSA. Total analytical error: from concept to application. www.aacc.org/publications/cln/articles/2013/september/total-analytic-error (Accessed August 2014).

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