title: Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 Systems for the Measurement of Hemoglobin A1c.
abstract: OBJECTIVE
  We evaluated the Bio-Rad (Irvine, CA) D-100 and the Sebia (Lisses, France) Capillarys 3 Tera for the measurement of hemoglobin A1c (HbA1c) in venous blood samples.
  
  
  METHODS
  Whole-blood samples and control material were analyzed with the D-100 and Capillarys 3 Tera and compared with our routine method, HLC-723G7 (Tosoh, Tokyo, Japan). An evaluation protocol to test precision, trueness, linearity, carryover, and selectivity was set up according to Clinical and Laboratory Standards Institute guidelines. The results were presented in National Glycohemoglobin Standardization Program and International Federation of Clinical Chemistry (IFCC) units.
  
  
  RESULTS
  Both systems showed excellent precision (total coefficients of variation <2%, IFCC) and bias (<0.3% or 3 mmol/mol). Linearity was demonstrated for HbA1c values from 3.8% (18 mmol/mol) to 18.5% (179 mmol/mol). Results were correlated with the routine method using Bland-Altman analysis, showing a mean difference of 0.33% or 3.6 mmol/mol for the D-100 and of 0.25% or 2.6 mmol/mol for the Capillarys 3 Tera vs HLC-723G7. None of the automated instruments were prone to interferences by labile HbA1c (≤10 g/L glucose), carbamylated hemoglobin (≤0.5 mmol/L potassium cyanate), hemoglobin variants, bilirubin (≤15 mg/dL), and triglycerides (≤3,360 mg/dL).
  
  
  CONCLUSIONS
  The Bio-Rad D-100 and the Sebia Capillarys 3 Tera instruments performed well for the determination of HbA1c in terms of quality criteria as well as for sample throughput.
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Margaux
authors.initials: M
authors.lastname: Herpol
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Katrien
authors.initials: K
authors.lastname: Lanckmans
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Stefaan
authors.initials: S
authors.lastname: Van Neyghem
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Pascale
authors.initials: P
authors.lastname: Clement
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Crevits
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Kim
authors.initials: K
authors.lastname: De Crem
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Frans K
authors.initials: FK
authors.lastname: Gorus
authors.affiliation: From the Department of Clinical Chemistry and Radio-Immunology, Universitair Ziekenhuis Brussel, Brussels, Belgium. ilse.weets@uzbrussel.be.
authors.forename: Ilse
authors.initials: I
authors.lastname: Weets
mesh_terms: D019075:Electrophoresis, Capillary / Q000295:instrumentation / Q000379:methods; D006442:Glycated Hemoglobin / Q000032:analysis*; D006452:Hemoglobinometry / Q000295:instrumentation* / Q000379:methods; D006801:Humans
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Analytical performance; Capillary zone electrophoresis; HPLC; Hemoglobin A1c