PMID- 26247176 OWN - NLM STAT- MEDLINE DCOM- 20160825 LR - 20221207 IS - 1873-2933 (Electronic) IS - 0009-9120 (Linking) VI - 48 IP - 16-17 DP - 2015 Nov TI - Identification of Hb Wayne and its effects on HbA1c measurement by 5 methods. PG - 1144-50 LID - S0009-9120(15)00380-X [pii] LID - 10.1016/j.clinbiochem.2015.07.100 [doi] AB - BACKGROUND: The World Health Organization and the American and Canadian Diabetes Associations approved HbA1c >6.5% as diagnostic for type 2 diabetes mellitus (T2DM). Hb variants and/or their chemically modified species can interfere with HbA1c measurements. We recently described a patient with Hb Wayne trait who was misdiagnosed with T2DM based on falsely elevated HbA1c. Hb Wayne is a clinically silent variant that exists as two isoforms: Hb Wayne I (Asn 139) and Hb Wayne II (Asp 139). METHODS: Hemoglobinopathy investigation was performed by HPLC (Bio-Rad VARIANT-II), alkaline and acid electrophoresis (Sebia Hydrasis2), capillary zone electrophoresis (Sebia CAPILLARYS2) and DNA sequencing. HbA1c was measured by five methods. RESULTS: Hb Wayne eluted as two small fractions with retention times of 1.0 and 1.46min on the HPLC (Bio-Rad VARIANT-II). Alkaline gel and capillary electrophoresis showed two small bands migrating faster than HbA. Hb Wayne generated spuriously high results on the Bio-Rad VARIANT-II Turbo 2.0, no results on the Tosoh G8, and did not interfere with either the Sebia CAPILLARYS2 or immunoassays from Roche (tinaquant) and Siemens (Bayer DCA2000+). Based on the Hb Wayne HPLC profile of 3 patients, an algorithm was developed to facilitate its detection, which identified 9 additional patients with Hb Wayne trait. CONCLUSIONS: We characterize Hb Wayne by chromatographic and electrophoretic techniques and show the effect of Hb Wayne on five common HbA1c methodologies. We developed a quality assurance tool to assist in detecting Hb Wayne trait during HbA1c analysis on the Bio-Rad VARIANT-II Turbo 2.0. CI - Copyright (c) 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. FAU - Rodriguez-Capote, Karina AU - Rodriguez-Capote K AD - DynaLIFE(DX) Diagnostic Laboratory Services, Edmonton, AB, Canada; Dept Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada. Electronic address: karina.capote@dynalifedx.com. FAU - Estey, Mathew P AU - Estey MP AD - DynaLIFE(DX) Diagnostic Laboratory Services, Edmonton, AB, Canada; Dept Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada. FAU - Barakauskas, Vilte E AU - Barakauskas VE AD - DynaLIFE(DX) Diagnostic Laboratory Services, Edmonton, AB, Canada; Dept Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada. FAU - Burton, Teralee AU - Burton T AD - Regina Qu'Appelle Health Region, Regina, SK, Canada. FAU - Holmes, Deborah AU - Holmes D AD - DynaLIFE(DX) Diagnostic Laboratory Services, Edmonton, AB, Canada. FAU - Krause, Richard AU - Krause R AD - Calgary Laboratory Services, Calgary, AB, Canada. FAU - Higgins, Trefor N AU - Higgins TN AD - DynaLIFE(DX) Diagnostic Laboratory Services, Edmonton, AB, Canada; Dept Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada. LA - eng PT - Journal Article DEP - 20150804 PL - United States TA - Clin Biochem JT - Clinical biochemistry JID - 0133660 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hemoglobins, Abnormal) RN - 0 (hemoglobin A1c protein, human) RN - 0 (hemoglobin Wayne) SB - IM MH - Algorithms MH - Chromatography, High Pressure Liquid/methods MH - Diabetes Mellitus, Type 2/metabolism MH - Electrophoresis, Capillary/methods MH - Glycated Hemoglobin/*metabolism MH - Hemoglobinopathies/diagnosis/metabolism MH - Hemoglobins, Abnormal/*metabolism MH - Humans MH - Sequence Analysis, DNA/methods OTO - NOTNLM OT - Diabetes OT - HPLC OT - HbA1c OT - Hemoglobinopathy OT - Interference OT - Quality assurance EDAT- 2015/08/08 06:00 MHDA- 2016/08/26 06:00 CRDT- 2015/08/07 06:00 PHST- 2015/06/19 00:00 [received] PHST- 2015/07/26 00:00 [revised] PHST- 2015/07/31 00:00 [accepted] PHST- 2015/08/07 06:00 [entrez] PHST- 2015/08/08 06:00 [pubmed] PHST- 2016/08/26 06:00 [medline] AID - S0009-9120(15)00380-X [pii] AID - 10.1016/j.clinbiochem.2015.07.100 [doi] PST - ppublish SO - Clin Biochem. 2015 Nov;48(16-17):1144-50. doi: 10.1016/j.clinbiochem.2015.07.100. Epub 2015 Aug 4.