title: Effects of hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by twelve methods.
abstract: BACKGROUND
  Hemoglobin C, D Punjab, E or S trait can interfere with hemoglobin A1c (HbA1c) results. We assessed whether they affect results obtained with 12 current assay methods.
  
  
  METHODS
  Hemoglobin AA (HbAA), HbAC, HbAD Punjab, HbAE and HbAS samples were analyzed on one enzymatic, nine ion-exchange HPLC and two Capillary Electrophoresis methods. Trinity ultra(2) boronate affinity HPLC was the comparative method. An overall test of coincidence of least-squared linear regression lines was performed to determine if HbA1c results were statistically significantly different from those of HbAA samples. Clinically significant interference was defined as >7% difference from HbAA at 6 or 9% HbA1c compared to ultra(2) using Deming regression.
  
  
  RESULTS
  All methods showed statistically significant effects for one or more variants. Clinically significant effects were observed for the Tosoh G8 variant mode and GX (all variants), GX V1.22 (all but HbAE) and G11 variant mode (HbAC). All other methods (Abbott Architect c Enzymatic, Bio-Rad D-100, Variant II NU and Variant II Turbo 2.0, Menarini HA-8180T thalassemia mode and HA-8180V variant mode, Sebia Capillarys 2 and Capillarys 3) showed no clinically significant differences.
  
  
  CONCLUSIONS
  Several methods showed clinically significant interference with HbA1c results from one or more variants which could adversely affect patient care.
authors.affiliation: Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, United States. Electronic address: RohlfingC@health.missouri.edu.
authors.forename: Curt
authors.initials: C
authors.lastname: Rohlfing
authors.affiliation: Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, United States.
authors.forename: Steven
authors.initials: S
authors.lastname: Hanson
authors.affiliation: European Reference Laboratory, Location Queen Beatrix Hospital, Winterswijk, The Netherlands.
authors.forename: Cas
authors.initials: C
authors.lastname: Weykamp
authors.affiliation: European Reference Laboratory, Location Queen Beatrix Hospital, Winterswijk, The Netherlands.
authors.forename: Carla
authors.initials: C
authors.lastname: Siebelder
authors.affiliation: DynaLIFE(DX) Diagnostic Laboratory Services, Edmonton, AB, Canada.
authors.forename: Trefor
authors.initials: T
authors.lastname: Higgins
authors.affiliation: Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, United States.
authors.forename: Ross
authors.initials: R
authors.lastname: Molinaro
authors.affiliation: University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Yip
authors.affiliation: Department of Pathology and Anatomical Sciences, University of Missouri, Columbia, MO, United States.
authors.forename: Randie R
authors.initials: RR
authors.lastname: Little
mesh_terms: D002846:Chromatography, Affinity / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002852:Chromatography, Ion Exchange / Q000379:methods*; D019075:Electrophoresis, Capillary / Q000379:methods*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006454:Hemoglobins / Q000737:chemistry*; D006801:Humans
chemical_list: D006442:Glycated Hemoglobin; D006454:Hemoglobins; C517652:hemoglobin A1c protein, human
keywords: Capillary Electrophoresis; Diabetes; HPLC; Hemoglobin A(1c); Hemoglobin variants; Immunoassay
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