Desirable performance standards for HbA1c analysis -- precision, accuracy and standardization Consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal College of Pathologists of Australasia (RCPA), Endocrine Society of Australia (ESA), and the Australian Diabetes Educators Association (ADEA)1)


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Abstract

BackgroundHbA1c (glycohaemoglobin) is universally used in the ongoing monitoring of all patients with diabetes. There are many % HbA1c target control rating recommendations by national, regional and international expert bodies for diabetes patients and these are variable around the world. General patient target control ratings are currently most often recommended as either <6.5% or <7.0% HbA1c, with <6.0% HbA1c stated for individual patients where clinically possible. This necessitates very precise HbA1c assays and the same patient values, irrespective of HbA1c method or area of the world.MethodsHbA1c targets recommended by major expert groups and published HbA1c assay precision (coefficient of variation, %CV) levels have been detailed. These have been compared with published biological variation levels and with calculated HbA1c error ranges at various HbA1c levels and %CV levels. In addition, these have been compared with the analytical precision necessary to differentiate between the upper limit of the normal range for HbA1c and targets recommended by expert groups for diabetes control.ResultsIntralaboratory analytical CVs of <2% are necessary and are achievable on automated HPLC analysers, and are supported on grounds of both clinical need and biological variation, as well as the need to differentiate the national, regional and international target recommendations from the upper limit of the normal range (<6.0% HbA1c level).ConclusionsRoutine methods with tight long-term imprecision with CVs of <2% are recommended. International HbA1c targets essentially require that all HbA1c methods be precise, and have minimal standardisation bias and minimal methodological interferences in individual patients.

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