Estimation of biological variation and reference change value of glycated hemoglobin (HbA1c) when two analytical methods are used

Uçar, Fatma; Erden, Gönül; Giniş, Zeynep; Öztürk, Gülfer; Sezer, Sevilay; Gürler, Mukaddes; Guneyk, Ahmet

doi:10.1016/j.clinbiochem.2013.05.055

Cited by 17 publications

(13 citation statements)

References 23 publications

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“…Therefore, the establishment of effective BV can contribute to the management of chronic diseases such as diabetes. At present, there are many reports on the BV of HbA1c, but the results are contradictory . And there is no report about the biological variation of GSA among the Chinese population.…”

Section: Introductioncontrasting

confidence: 82%

“…At present, there are many reports on the BV of HbA1c, but the results are contradictory. 11 And there is no report about the biological variation of GSA among the Chinese population. The current study measured the biological variation of HbA1c and GSA in 19 nondiabetic subjects through the standard protocol designed by EFLM.…”

Section: Federation Of Clinical Chemistry and Laboratory Medicine (Eflm)mentioning

confidence: 99%

“…The prevalence of diabetes among Chinese adults is as high as 11.6%, and about 113 million Chinese have type 2 diabetes mellitus (T2DM). 1 Glycated hemoglobin (HbA1c) plays an increasingly important role in the diagnosis and treatment of diabetes.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Liu

Zeng

et al. 2018

Clinical Laboratory Analysis

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Background Glycated hemoglobin (HbA1c) and glycated serum albumin ( GSA ) are used to evaluate the mean blood glucose levels. To ensure safe clinical application of HbA1c and GSA , reliable biological variation ( BV ) data are required. The aim of this research was to define the BV of HbA1c and GSA employing stringent rules. Methods Blood samples were drawn from 19 healthy subjects (10 females, nine males) once per week for 5 weeks. All samples were analyzed using enzymatic method for GSA and HPLC for HbA1c. The data were assessed for outliers, normality and variance homogeneity, and coefficient of variation (by ANOVA ) for BV . Sex‐stratified BV including within‐subject ( CV I ) and between‐subject ( CV G ) was defined for HbA1c and GSA . Results The following estimates for BV values for CV I and CV G , respectively, were GSA : 1.23% and 4.67%, Alb: 0.75% and 3.18%, and HbA1c: 0.12% and 2.91%. The RCV of GSA was 3.61%, and HbA1c was 1.41%. And the II was 0.26 for GSA , and 0.07 for HbA1c, both of them less than 0.6. According to the 95% CI , the CV I of HbA1c was statistically different between females and males. And both the CV G of HbA1c and GSA were statistically different between females and males. Conclusion All CV I and CV G estimates were lower than those reported in the online BV database. And there is a significant difference between males and females. Analytical performance specifications derived from BV of this research can be applied internationally.

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Section: Introductioncontrasting

confidence: 82%

Section: Federation Of Clinical Chemistry and Laboratory Medicine (Eflm)mentioning

confidence: 99%

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Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Liu

Zeng

et al. 2018

Clinical Laboratory Analysis

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“…Studies that are conducted with the boronate affinity method had different results than those designed with ion-exchange. Ucar et al [11] calculated CVI and CVG as 2.15% and 4.03%. During 7 days and for 12 samples in 45 healthy men CVI and CVG values were reported as 1.7% and 4%.…”

Section: Discussionmentioning

confidence: 99%

Biological variation components of glycated hemoglobin HbA1c on tosoh G7 HPLC

Ercan¹

2018

Ann Clin Anal Med

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Aim: Biological variation (BV) of the HbA1c test can be affected by analysis method, sampling period, and disease activity. The aim of the present study was to examine the impact of CVI, CVA, and II for Tosoh G7 system. Material and Method: 96 samples from 12 healthy volunteers were collected for every two weeks during a two-month period. HbA1c levels of all samples were measured by G7 HPLC (non-porous ion-exchange) Analyser. Biological variation parameters CVI, CVA, CVG, RCV, and II were calculated. Results: The mean of HbA1c was 5.10% (32.3 mmol/mol). CVA was calculated as 2.81%. The CVI and CVG for HbA1c were 1.69% and 7.56%, respectively. RCV and II values were 9.08% and 0.22. Discussion: According to our results, the sampling period and study method were fundamental to determining biological variation parameters. When using the Tosoh G7 system, we observed similar results to other methods, e.g. boronate affinity or immunoturbidimetry. Low individuality index of HbA1c presented that the analyte had marked individuality and that the population-based reference values had low utility for disease monitoring. Thus, estimation and inclusion of RCV in laboratory reports for HbA1c will guide the clinicians in evaluating the importance of difference between serial results and glycemic status of the patients.

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“…Therefore, accurate and precise measurement of HbA 1c is extremely important. The routine determination of HbA 1c can be achieved by methods based on different principles: immune‐turbidimetric, boronate affinity chromatography, ion‐exchange high‐performance liquid chromatography (HPLC), and enzymatic assay ; among these, cation HPLC is one of the methods generally used for the HbA 1c determination. Several studies have reported a significant bias among analytical methods to measure HbA 1c levels .…”

Section: Introductionmentioning

confidence: 99%

Performances of Capillary Electrophoresis and HPLC Methods in HbA_1c Determination: Diagnostic Accuracy in HbS and HbD‐Iran Variants' Presence

Dessı̀

Pieri

Pignalosa

et al. 2014

Clinical Laboratory Analysis

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Estimation of biological variation and reference change value of glycated hemoglobin (HbA1c) when two analytical methods are used

Cited by 17 publications

References 23 publications

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Biological variation components of glycated hemoglobin HbA1c on tosoh G7 HPLC

Performances of Capillary Electrophoresis and HPLC Methods in HbA_1c Determination: Diagnostic Accuracy in HbS and HbD‐Iran Variants' Presence

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Estimation of biological variation and reference change value of glycated hemoglobin (HbA1c) when two analytical methods are used

Cited by 17 publications

References 23 publications

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Biological variation components of glycated hemoglobin HbA1c on tosoh G7 HPLC

Performances of Capillary Electrophoresis and HPLC Methods in HbA1c Determination: Diagnostic Accuracy in HbS and HbD‐Iran Variants' Presence

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Product

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Performances of Capillary Electrophoresis and HPLC Methods in HbA_1c Determination: Diagnostic Accuracy in HbS and HbD‐Iran Variants' Presence