Effect of the different assays of HbA1c on diabetic patients monitoring

Razi, F. and Nasli Esfahani, E. and Rahnamaye Farzami, M. and Tootee, A. and Qorbani, M. and Ebrahimi, S.A. and Nahid, M. and Pasalar, P. (2015) Effect of the different assays of HbA1c on diabetic patients monitoring. Journal of Diabetes and Metabolic Disorders, 14 (1).

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Abstract

Background: HbA1c test is widely used for glycemic monitoring of diabetic patients. This study aimed to evaluate clinical performance of different assays for classification of patients into controlled and uncontrolled group base on ADA recommendations. Method: A total of 154 samples from patients with diabetes type 2 with HbA1c concentration coveringthe whole clinical range were analyzed by four commercially methods; D-10 Hb A1c (Bio-Rad Laboratories), Cobas Integra 400 (Roche Diagnostics), NycoCard Reader II (Axis-Shield) and DS5 (Drew Scientific). For each individual assay, patient's results were classified into controlled and uncontrolled groups (less or more than three decision levels; 6.5, 7 and 8) compared to D10 results as reference method. The frequency of each group and also sensitivity, specificity, negative and positive predictive value were estimated. Results: We found a significant correlation between assays (r: 0.937-0.945). Sensitivity, specificity, and positive and negative predictive values of the evaluated method to identify uncontrolled patients were as follows: 49.2-95.7, 86.5-100, 89.1-100, and 52.9-93.3; respectively. Conclusions: Results show that some HbA1c assays capability to classify diabetic patients according to HbA1c level is still unacceptable. © 2015 Razi et al.

Item Type: Article
Additional Information: cited By 3
Uncontrolled Keywords: hemoglobin A1c, Article; assay; Cobas Integra 400 assay; controlled study; D 10 Hb A1c assay; diagnostic test accuracy study; DS5 assay; high performance liquid chromatography; human; major clinical study; non insulin dependent diabetes mellitus; NycoCard Reader II assay; patient coding; patient monitoring; predictive value; sensitivity and specificity; standard
Depositing User: EPrints System Admin
Date Deposited: 19 Jul 2017 10:13
Last Modified: 19 Jul 2017 10:13
URI: http://eprints.iums.ac.ir/id/eprint/26

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