Effects of hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by twelve methods

• Type of Material: Article
• Authors: Curt Rohlfing, University of Missouri; Steven Hanson, University of Missouri; Cas Weykamp, Location Queen Beatrix Hospital; Carla Siebelder, Location Queen Beatrix Hospital; Trefor Higgins, DynaLIFEDX Diagnostic Laboratory Services; Ross Molinaro, Emory University; Paul M. Yip, University Health Network and University of Toronto; Randie R Little, University of Missouri
• Language: English
• Date: 2016-04-01
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2016 Elsevier B.V. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cca.2016.01.031
• Title of Journal or Parent Work: Clinica Chimica Acta
• ISSN: 0009-8981
• Volume: 455
• Start Page: 80
• End Page: 83
• Keywords: diabetes; HPLC; Capillary electrophoresis; immunoassay; hemoglobin A1c; hemoglobin variants
• Research Categories: Health Sciences, Immunology; Health Sciences, Pathology; Biology, Molecular

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 ultra2 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 ultra2 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.