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The long and winding road to optimal HbA1c measurement
Randie R Little1, Curt L Rohlfing
1Department of Pathology and Anatomical Sciences, University of Missouri School of Medicine, One Hospital Dr., Columbia, MO 65212, USA. littler@health.missouri.edu
Insights
Standardizing hemoglobin A1c (HbA1c) testing has improved diabetes management since 1996. Ongoing efforts address new methods and point-of-care testing for accurate results.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Laboratory Medicine
Background:
- Hemoglobin A1c (HbA1c) is crucial for monitoring diabetes mellitus and predicting complications.
- Early trials like DCCT and UKPDS established HbA1c targets but faced comparability issues.
- Lack of standardization hindered clinical application of HbA1c results.
Purpose of the Study:
- To review the historical development and current status of HbA1c standardization.
- To discuss advancements including the International Federation of Clinical Chemistry (IFCC) reference method.
- To highlight emerging issues like point-of-care (POC) testing and diagnostic use.
Main Methods:
- Review of landmark clinical trials (DCCT, UKPDS).
- Analysis of the National Glycohemoglobin Standardization Program (NGSP) initiation and success.
- Examination of the development of higher-order reference methods and POC testing.
Main Results:
- HbA1c standardization efforts, initiated in 1996 by NGSP, have been highly successful.
- Significant progress in aligning HbA1c results with DCCT/UKPDS values.
- Emergence of IFCC reference methods and increased use of POC testing.
Conclusions:
- HbA1c standardization has greatly improved diabetes care and comparability of results.
- Continued evolution includes advanced reference methods and point-of-care technologies.
- Understanding current limitations in HbA1c testing is vital for healthcare providers.
Abstract:
The importance of hemoglobin A1c (HbA1c) as an indicator of mean glycemia and risks for complications in patients with diabetes mellitus was established by the results of long-term clinical trials, most notably the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), published in 1993 and 1998 respectively. However, clinical application of recommended HbA1c targets that were based on these studies was difficult due to lack of comparability of HbA1c results among assay methods and laboratories. Thus, the National Glycohemoglobin Standardization Program (NGSP) was initiated in 1996 with the goal of standardizing HbA1c results to those of the DCCT/UKPDS. HbA1c standardization efforts have been highly successful; however, a number of issues have emerged on the "long and winding road" to better HbA1c, including the development of a higher-order HbA1c reference method by the International Federation of Clinical Chemistry (IFCC), recommendations to use HbA1c to diagnose as well as monitor diabetes, and point-of-care (POC) HbA1c testing. Here, we review the past, present and future of HbA1c standardization and describe the current status of HbA1c testing, including limitations that healthcare providers need to be aware of when interpreting HbA1c results.
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