Current aspects in hemoglobin A1c detection: A review

Abstract

Type 2 diabetes mellitus (T2DM) is a pressing health issue that threatens global health and the productivity of populations worldwide. Despite its long-recognized role in diabetes management, glycated hemoglobin (HbA1c) only received WHO endorsement as a T2DM diagnostic tool in 2011. Although conventional plasma-specific tests have long been utilized to diagnose T2DM, the public should be informed that plasma-specific tests are not markedly better than HbA1c tests, particularly in terms of variability and convenience for diagnosing diabetes. In the midst of the debates associated with establishing HbA1c as the preeminent diabetes diagnostic tool, unceasing efforts to standardize HbA1c tests have played an integral part in achieving more efficient communication from laboratory to clinical practice and thus better diabetes care. This review discusses the current status of HbA1c tests in the diagnosis, prevention, treatment and management of T2DM across the globe, focusing on increasing the recognition of glycated hemoglobin variants with effective utilization of different HbA1c methods, updating the current status of HbA1c standardization programs, tapping into the potential of POC analyzers to establish a cost-effective HbA1c test for diabetes care, and inspiring the advancement of HbA1c biosensors for future clinical usage.

The cutoffs and performance of glycated hemoglobin for diagnosing diabetes and prediabetes in a young and middle-aged population and in an elderly population

“…Interestingly, the age-specific HbA1c criteria were higher in Yang's study than in the present study in both the young and middle-aged population (6.1% (43 mmol/mol) to 6.4% (46 mmol/mol) vs. 5.7% (39 mmol/mol)) and the elderly population (6.5% (48 mmol/mol) to 6.4% (46 mmol/mol) vs. 5.9% (41 mmol/ mol)). The differences of HbA1c cutoffs among different populations in the same age range were also observed in other previous studies [20,27,31], which could be partly explained by variations in HbA1c levels derived from racial disparities, regional discrepancies, inconsistencies of blood sample collection time and HbA1c tests among different laboratories, as well as differences in the prevalence of hemoglobinopathies [8,14,25].…”

“…However, the diagnosis of diabetes can be very complicated, due to variations in the symptoms of diabetes [8]. Over the past four decades, although there have been significant changes in the diagnostic and classification criteria for diabetes and prediabetes, the most widely accepted diagnostic test remains the fasting plasma glucose and the 2-h plasma glucose by an oral glucose tolerance test (OGTT) [9].…”

“…Over the past four decades, although there have been significant changes in the diagnostic and classification criteria for diabetes and prediabetes, the most widely accepted diagnostic test remains the fasting plasma glucose and the 2-h plasma glucose by an oral glucose tolerance test (OGTT) [9]. However, the use of the OGTT for the diagnosis of diabetes was discouraged for use in clinical settings due to its inconvenience, high cost, and poor reproducibility [8,10].…”

Impact of HbA1c Testing at Point of Care on Diabetes Management

“…34 The remarkable improvement of analytical performance of POC devices for HbA1c testing in recent years, together with the development of new diagnostic materials 64 or the miniaturization of devices 48 argue in favor of an expansive diagnostic potential in the near future. 65 A further consideration for POC testing success is the implementation of appropriate quality control measures. Participation in external quality control programs or proficiency testing (EQA, external quality assessment) 66,67 is a possibility and can assist in monitoring quality of results.…”

Glycated hemoglobin-detection methods based on electrochemical biosensors

“…Scheller and co-workers reported on FcBA-based HbA1c sensors [44][45][46][47]. They used sensor electrodes modified with zirconiumdioxide NPs to immobilize HbA1c from whole-blood samples [46].…”