Evaluation of the Accuracy of the Glycated Hemoglobin (HbA1c) Index Measured by the Clover A1c Self Analyzer Device Compared to Standard Methods

Document Type : Original Article(s)

Authors

1 General Practitioner, Prevention and Control of Cardiovascular Diseases and Diabetes Office, Isfahan Province Heath Center, Isfahan University of Medical Sciences, Isfahan, Iran

2 Professor, Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.

3 PhD in Cellular and Molecular Biology Research expert, Isfahan Province Heath Center, Isfahan University of Medical Sciences, Isfahan, Iran.

4 PhD in Epidemiology, Isfahan Endocrine and Metabolism Research Centre (IEMRC), School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

5 Bachelor of Clinical Laboratory, Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

6 Professor, Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

Abstract

Background: Given that HbA1C is a critical indicator in the diagnosis and control of diabetes, various methods exist for its measurement. This study aimed to determine the accuracy of the HbA1C index measured by the Clover A1c self analyzer device in health centers of Isfahan province compared to the HPLC method.
Methods: In this cross-sectional study, samples were taken from 99 patients. Three blood samples were taken from each patient: one venous blood sample and two capillary blood samples. The HbA1C measurement from the venous blood sample was performed using the standard HPLC method, while the capillary blood samples from the right and left hands were measured using the Clover A1c self analyzer device. The concordance of the measurements from the two devices was assessed using the Intra-cluster correlation coefficient (ICC) and the Bland-Altman method.
Findings: A comparison of the results reported by the two devices showed that the mean serum HbA1C measured by the reference device was 7.97 ± 1.50. The mean HbA1C measured by the Clover Self device on the right hand was 7.51 ± 1.29, and the mean on the left was 7.59 ± 1.28. The concordance of the measurements from both hands by the Clover Self device with the reference device was ICC = 0.938 with a 95% confidence interval (0.913 - 0.957) (P < 0.001).
Conclusion: The results of the present study indicate excellent concordance between the results obtained from the two devices, confirming the validity of the Clover Self device.

Highlights

Ramesh Hosseinkhani: PubMed

Awat Feizi: Google Scholar, PubMed

Zahra Mollabashi: Google Scholar 

Mojtaba Akbari: Google Scholar

Mansour Siavash: Google Scholar, PubMed

Keywords

Main Subjects

References

  1. Selby NM, Taal MW. An updated overview of diabetic nephropathy: Diagnosis, prognosis, treatment goals and latest guidelines. Diabetes Obes Metab 2020; 22(Suppl 1): 3-15.
  2. Park J, Zhang P, Wang Y, Zhou X, Look KA, Bigman ET. High out-of-pocket health care cost burden among Medicare beneficiaries with diabetes, 1999–2017. Diabetes Care 2021; 44(8): 1797-804.
  3. Khamseh ME, Sepanlou SG, Hashemi-Madani N, Joukar F, Mehrparvar AH, Faramarzi E, et al. Nationwide prevalence of diabetes and prediabetes and associated risk factors among Iranian adults: analysis of data from PERSIAN cohort study. Diabetes Ther 2021; 12(11): 2921-38.
  4. Evans M, Welsh Z, Ells S, Seibold A. The impact of flash glucose monitoring on glycaemic control as measured by HbA1c: a meta-analysis of clinical trials and rweal-world observational studies. Diabetes Ther 2020; 11(1): 83-95.
  5. English E, Lenters-Westra E. HbA1c method performance: the great success story of global standardization. Crit Rev Clin Lab Sci 2018; 55(6): 408-19.
  6. Su JB, Zhao LH, Zhang XL, Cai HL, Huang HY, Xu F, et al. HbA1c variability and diabetic peripheral neuropathy in type 2 diabetic patients. Cardiovasc Diabetol 2018; 17(1): 47.
  7. Little RR, Rohlfing CL, Sacks DB. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem 2011; 57(2): 205-14.
  8. Saiedullah M, Ferdoush M, Begum S, Rahman MR, Sarkar A, Ahmad A. Studies on subfractions of hemoglobin A1 in diabetic subjects. Diab Endocr J. 2009; 38(Suppl 1): 20.
  9. Davari Edalat Pana S, Tousi N, Rahimi L, Sabouri G. Comparison of Two Methods for Measurement of HbA1c in Two University Hospital of Mshhad. Patient Saf Qual Improv 2015; 3(3): 262-5.
  10. ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, et al. Classification and diagnosis of diabetes: Standards of Medical Care in Diabetes-2023. Diabetes Care 2023; 46(Suppl 1): S19-S40.
  11. Cicchetti DV. Guidelines, criteria, and rules of thumb for evaluating normed and standardized assessment instruments in psychology. Psychological Psychological Assessment 1994; 6(4): 284-90.
  12. Karami A, Baradaran A. Comparative evaluation of three different methods for HbA1c measurement with High-performance liquid chromatography in diabetic patients. Adv Biomed Res 2014; 3: 94.
  13. Jalali MT, Shahbazian HB, Afsharmanesh MR, Mousavi Dehmordi R, Saki A. Evaluation of accuracy, precision and agreement of five Hba1c measurement methods with HPLC reference method. Med Lab J 2016; 10(2): 58-64.
  14. Khodabandeh-Shahraki P, Akbari M, Tabatabaee A, Mobasherizadeh S, Siavash M, The accuracy of Glycosylated Hemoglobin a Index Measurement in Medical Laboratories in Isfahan City [in Persian]. J Isfahan Med Sch 2022; 40(673): 368-74.
  15. .Khodanga S, Singh G, Pakhare P, Joshi R, Diagnostic accuracy of point-of-care tests measuring glycosylated hemogolobin (HbA1C) for glycemic control :a field study in India. Cureus 2021; 13(9): e17920.
  16. Arnold WD, Kupfer K, Little RR, Amar M, Horowitz B, Godbole N, et al. Accuracy and Precision of a Point-of-Care HbA1c Test. J Diabetes Sci Technol 2020; 14(5): 883-9.
Journal of Isfahan Medical School
Volume 42, Issue 795
3rd Week, February
January and February 2025
Pages 1114-1122

Files

History

  • Receive Date: 01 September 2024
  • Accept Date: 26 January 2025

Share

How to cite

Statistics