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Background A major objective of the IFCC Task Force on implementation of HbA1c standardization is to develop a model to define quality targets for HbA1c. Methods Two generic models, the Biological Variation and Sigma-metrics model, are investigated. Variables in the models were selected for HbA1c and data of EQA/PT programs were used 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 2 sigma criterion. Conclusion The Biological Variation and Sigma-metrics model 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 requirements related to e.g. use for diagnosis/monitoring or requirements of (inter)national authorities. With the aim of reaching international consensus on advice regarding quality targets for HbA1c, 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 2 and 4 sigma 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.

Hanas R. and John G. 2010 Consensus Statement on the Worldwide Standardization of the Hemoglobin A1c Measurement.

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