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

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. © 2025 Isfahan University of Medical Sciences(IUMS). All rights reserved.