HbA1c method performance: The great success story of global standardization

English, Emma and Lenters-Westra, Erna (2018) HbA1c method performance: The great success story of global standardization. Critical Reviews in Clinical Laboratory Sciences, 55 (6). pp. 408-419. ISSN 1040-8363

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Abstract

Diagnosing and monitoring the treatment of people with diabetes is a global issue and uses considerable resources in laboratories and clinics worldwide. Hemoglobin A1c (HbA1c) has been the mainstay of monitoring glycemic control in people with diabetes for many years and more recently it has been advocated as a diagnostic tool for type 2 diabetes mellitus (T2DM). Good analytical performance is key to the successful use of any laboratory test, but is critical when using the test to diagnose disease, especially when the potential number of diagnoses could exceed 500 million people. Very small variations in bias or increased imprecision could lead to either a missed diagnosis or overdiagnosis of the disease and given the scale of the global disease burden, this could mean erroneous categorization of potentially millions of people. Fundamental to good performance of diagnostic testing is standardization, with defined reference materials and measurement procedures. In this review, we discuss the historical steps to first harmonize HbA1c testing, followed by the global standardization efforts and provide an update on the current situation and future goals for HbA1c testing.

Item Type: Article
Uncontrolled Keywords: hba1c,standardization,diabetes
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Depositing User: LivePure Connector
Date Deposited: 31 Jul 2018 16:30
Last Modified: 04 Nov 2020 00:55
URI: https://ueaeprints.uea.ac.uk/id/eprint/67904
DOI: 10.1080/10408363.2018.1480591

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