Analytical performance evaluation of the Norudia HbA<sub>1c</sub> assay

Background Diabetes mellitus (DM) is a chronic metabolic disorder that is increasing globally. It is associated with chronic complications that are more common among patients with poor glycaemic control. Glycosylated haemoglobin (HbA1c) is the gold standard for monitoring glycaemic control. Measurements of HbA1c are relatively expensive and not available in some remote areas of developing countries. Methods We conducted a cross‐sectional study to evaluate the agreement between the calculated and measured HbA1c levels. The equation to compute the calculated HbA1c also incorporated the fasting blood glucose (FBG) level and was as follows: HbA1c = 2.6 + 0.03 × FBG (mg/dl). Result We enrolled 290 patients with type 2 DM in this study. Of these, 204 (70.3%) were females and the mean (SD) age was 54.9 (12.8) years. The mean (SD) diabetes duration was 6.8 (5.5) years. There were 211 (72.8%) patients using oral hypoglycaemic agents, 62 (21.4%) were using insulin and 17 (5.9%) were using both insulin and oral hypoglycaemic agents. There was a borderline difference between the mean (SD) calculated and measured HbA1c levels (p = 0.054). There was a significant correlation between the calculated and measured HbA1c (r = 0.595, p < 0.001). However, there was no agreement between the calculated and measured HbA1c. The bias ±SD (limits of agreement) for calculated versus measured HbA1c was −1.008 ± 2.02% (−5.05, 2.032). Conclusion Despite the presence of a significant correlation between the calculated and measured HbA1c, the calculated level has shown an unacceptable agreement with the measured HbA1c.

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“…It is worth to be mentioned that different methods which were used to measure HbA 1c showed acceptable accuracy. 29 …”

Section: Discussionmentioning

confidence: 99%

The calculated versus the measured glycosylated haemoglobin (HbA_1c) levels in patients with type 2 diabetes mellitus

Musa

Omar

Sharif

et al. 2021

Clinical Laboratory Analysis

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Poor glycemic control and associated factors in diabetic people attending a reference outpatient clinic in Mato Grosso, Brazil

Espinosa

Almeida

Nascimento

2021

invest. educ. enferm

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Objective. To identify the proportion of poor of glycemic control and associated factors among people with type 2 diabetes attending a regional reference outpatient clinic in Mato Grosso (Brazil). Methods. This is a cross-sectional quantitative study based on data from medical records of 338 people with type 2 diabetes who attend a state reference outpatient clinic in Mato Grosso (Brazil). Information on glycemic control, sociodemographic factors, lifestyle and clinical conditions was collected. Results. The prevalence of elevated glycated hemoglobin was 47.34%. In the Poisson multiple regression model analysis with robust variance, poor glycemic control was significantly associated (p<0.05) with the following factors: insulin use (Prevalence Ratio -PR = 2.03), fasting glucose ≤70 and ≥100 mg/dL (PR = 2.0), postprandial glucose ≥180 mg/dL (PR = 1.76), no physical activity (PR = 1.62), the interaction between age group ≤59 years and the time of disease diagnosis >10 years (PR = 1.58), and presence of arterial hypertension (PR = 0.79). Conclusion. Most users of the reference outpatient clinic with type 2 diabetes had poor glycemic control associated with risk factors that alter glycated hemoglobin and negatively affect the achievement of established glycemic levels.

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Speculation of hemoglobin A<sub>3</sub> peak position in clinical cation exchange high performance liquid chromatogram of the diabetic blood sample with microarray isoelectric focusing

Guo

Luo

et al. 2021

CJCSP

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Analytical performance evaluation of the Norudia HbA_1c assay

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 3 publications

References 23 publications

The calculated versus the measured glycosylated haemoglobin (HbA_1c) levels in patients with type 2 diabetes mellitus

The calculated versus the measured glycosylated haemoglobin (HbA_1c) levels in patients with type 2 diabetes mellitus

Poor glycemic control and associated factors in diabetic people attending a reference outpatient clinic in Mato Grosso, Brazil

Speculation of hemoglobin A<sub>3</sub> peak position in clinical cation exchange high performance liquid chromatogram of the diabetic blood sample with microarray isoelectric focusing

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Analytical performance evaluation of the Norudia HbA1c assay

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 3 publications

References 23 publications

The calculated versus the measured glycosylated haemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus

The calculated versus the measured glycosylated haemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus

Poor glycemic control and associated factors in diabetic people attending a reference outpatient clinic in Mato Grosso, Brazil

Speculation of hemoglobin A&lt;sub&gt;3&lt;/sub&gt; peak position in clinical cation exchange high performance liquid chromatogram of the diabetic blood sample with microarray isoelectric focusing

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Analytical performance evaluation of the Norudia HbA_1c assay

The calculated versus the measured glycosylated haemoglobin (HbA_1c) levels in patients with type 2 diabetes mellitus

The calculated versus the measured glycosylated haemoglobin (HbA_1c) levels in patients with type 2 diabetes mellitus

Speculation of hemoglobin A<sub>3</sub> peak position in clinical cation exchange high performance liquid chromatogram of the diabetic blood sample with microarray isoelectric focusing