title: Effect of the different assays of HbA1c on diabetic patients monitoring.
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.
  
  
  METHODS
  A total of 154 samples from patients with diabetes type 2 with HbA1c concentration covering the 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.
authors.affiliation: Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Farideh
authors.initials: F
authors.lastname: Razi
authors.affiliation: Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Ensieh
authors.initials: E
authors.lastname: Nasli Esfahani
authors.affiliation: Reference Health Laboratory of Iran, Ministry of Health, Tehran, Iran.
authors.forename: Marjan
authors.initials: M
authors.lastname: Rahnamaye Farzami
authors.affiliation: Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Tootee
authors.affiliation: Department of Community Medicine, Alborz University of Medical Sciences, Karaj, Iran ; Non communicable Diseases Research Center, Endocrinology and Metabolism Population, Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mostafa
authors.initials: M
authors.lastname: Qorbani
authors.affiliation: Massoud Clinical Laboratory, Tehran, Iran.
authors.forename: Soltan Ahmad
authors.initials: SA
authors.lastname: Ebrahimi
authors.affiliation: Massoud Clinical Laboratory, Tehran, Iran.
authors.forename: Mehrzad
authors.initials: M
authors.lastname: Nahid
authors.affiliation: Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Parvin
authors.initials: P
authors.lastname: Pasalar
keywords: Decision level; Diabetes; Glycemic control; HbA1c