title: Multicenter evaluation of hemoglobin A1c assay on capillary electrophoresis.
abstract: BACKGROUND
  Hemoglobin A1c (HbA1c) measurement is currently used for the routine monitoring of long-term glycemic status, thus playing a fundamental role in the management of this disease. Since this marker has recently been recommended as an additional tool for diagnosing diabetes, it's of the utmost importance to ensure that the precision and accuracy of HbA1c methods are satisfactory.
  
  
  METHODS
  We assessed the analytical performances of the Capillarys 2 Flex Piercing® analyzer and compared the results obtained with those from two other widely used HPLC instruments. Furthermore, we evaluated the convenience and ergonomics of the system in authentic routine work conditions in three centers.
  
  
  RESULTS
  Within-laboratory (n=40) and between-laboratory (n=120) imprecision CV% using four blood samples with different concentrations of HbA1c were <3.4% and <3.1% using IFCC units and <2.1% and <2.0% using NGSP units, respectively. The obtained trueness (<3 mmol/mol, <0.3%) was highly satisfactory, nor was HbA1c measurement compromised by the presence of the commonly present hemoglobinopathies. The comparison made with established methods revealed excellent agreement (r>0.985).
  
  
  CONCLUSIONS
  The evaluated method is precise, accurate and robust, with a high throughput. It also allows the identification of the most frequent Hb variants and therefore may be a valid alternative to other methods currently proposed for routine use in clinical laboratories.
authors.affiliation: Department of Laboratory Medicine, University Hospital of Padova, Via Giustiniani 2, 35128 Padova, Italy.
authors.forename: Mariela
authors.initials: M
authors.lastname: Marinova
authors.forename: Sara
authors.initials: S
authors.lastname: Altinier
authors.forename: Anna
authors.initials: A
authors.lastname: Caldini
authors.forename: Gabriella
authors.initials: G
authors.lastname: Passerini
authors.forename: Giorgio
authors.initials: G
authors.lastname: Pizzagalli
authors.forename: Marco
authors.initials: M
authors.lastname: Brogi
authors.forename: Martina
authors.initials: M
authors.lastname: Zaninotto
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Ceriotti
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
mesh_terms: D057205:Automation, Laboratory; D015415:Biomarkers / Q000097:blood; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis*; D019075:Electrophoresis, Capillary; D005319:Fetal Hemoglobin / Q000378:metabolism; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006443:Hemoglobin A2 / Q000378:metabolism; D006801:Humans; D015588:Observer Variation; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017086:beta-Thalassemia / Q000097:blood*
chemical_list: D015415:Biomarkers; D005319:Fetal Hemoglobin; D006442:Glycated Hemoglobin; D006443:Hemoglobin A2; C517652:hemoglobin A1c protein, human
keywords: CE; CV; Capillary electrophoresis; Coefficient of variation; Diabetes; HPLC; Hb; HbA(1c); Hemoglobin; Hemoglobin A(1c), glycated hemoglobin; High-performance liquid chromatography; IFCC; International Federation of Clinical Chemistry and Laboratory Medicine; NGSP; National Glycohemoglobin Standardization Program; SD; SQS; Sebia Qualification Samples; Standard deviation; cHb; carbamylated hemoglobin