Toward High-Quality Real-World Laboratory Data in the Era of Healthcare Big Data
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Ann Lab Med 2013; 33(6): 393-400
Published online November 1, 2013 https://doi.org/10.3343/alm.2013.33.6.393
Copyright © Korean Society for Laboratory Medicine.
Cas Weykamp, Ph.D.
MCA Laboratory, Queen Beatrix Hospital, Winterswijk, Netherlands
Correspondence to: Cas Weykamp
MCA Laboratory, Queen Beatrix Hospital, Beatrix Park 1, 7101 BN Winterswijk, Netherlands
Tel: +31-543-544774
Fax: +31-543-524265
E-mail: c.w.weykamp@skbwinterswijk.nl
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
After the relationship between glycemic control and the HbA1c concentration was demonstrated, many tests have been developed to determine the HbA1c concentration. The test results are standardized to the International Federation of Clinical Chemistry (IFCC) Reference Measurement Procedure (RMP) in harmony with the efforts of the National Glycohemoglobin Standardization Program (NGSP). The longitudinal use of the test requires strict quality management including accreditation of the laboratory, a dedicated internal control design, participation in an external quality assessment (EQA) program (proficiency test), and careful consideration of pre- and post-analytical aspects of the test. Performance goals for optimizing determination of the HbA1c concentration have been described. As an index of long-term glycemic control and a risk predictor, the HbA1c concentration is an indispensable part of routine management of diabetes. Because of the improving quality of the test, the HbA1c concentration is being increasingly applied in the diagnosis of diabetes. There are, however, concerns of this application in point-of-care settings. The HbA1c concentration is also used to achieve stringent control in pregnant diabetic patients. Strict standardization enables the definition of universal reference values and clinical decision limits. This review describes the present status of analytical and clinical aspects of determining the HbA1c concentration and highlights the challenges involved.
Keywords: HbA1c, Diabetes, Standardization, Analytical aspects, Clinical aspects