title: Effect of HbE heterozygosity on the measurement of HbA1c.
abstract: Measurement of HbA1c provides an excellent measure of glycaemic control for diabetic patients. However, haemoglobin (Hb) variants are known to interfere with HbA1c analysis. In our laboratory HbA1c measurement is performed by Variant II turbo 2.0. The aim of this study is to investigate the influence of HbE trait on HbA1c analysis.
  
  
  
  Haemoglobin variants were identified by HbA1c analysis in 93 of 3522 samples sent to our laboratory in a period of 1 month. Haemoglobin analysis identified HbE trait in 81 of 93 samples. To determine the influence of HbE trait on HbA1c analysis by Variant II Tubo 2.0, boronate affinity high performance liquid chromatography (HPLC) method (Primus PDQ) was used as the comparison method. Two stage linear regression analysis, Bland Altman plot and Deming regression analysis were performed to analyse whether the presence of HbE trait produced a statistically significant difference in the results. The total allowable error for HbA1c by the Royal Australasian College of Pathologists (RCPA) external quality assurance is 5%. Hence clinically significant difference is more than 5% at the medical decision level of 6% and 9%.
  
  
  
  Statistically and clinically significant higher results were observed in Variant II Turbo 2.0 due to the presence of HbE trait. A positive bias of ∼10% was observed at the medical decision levels.
  
  
  
  Laboratories should be cautious when evaluating HbA1c results in the presence of haemoglobin variants.
authors: Department of Pathology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. pavai@ummc.edu.my
authors: Pavai
authors: P
authors: Sthaneshwar
authors: Hemalatha
authors: H
authors: Shanmugam
authors: Vong Geok
authors: VG
authors: Swan
authors: Nizaruddin
authors: N
authors: Nasurdin
authors: Kohilavani
authors: K
authors: Tanggaiah
mesh_terms: D002851:Chromatography, High Pressure Liquid; D006442:Glycated Hemoglobin / Q000032:analysis*; D006446:Hemoglobin E / Q000235:genetics*; D006579:Heterozygote; D006801:Humans; D016014:Linear Models; D015203:Reproducibility of Results
chemical_list: D006442:Glycated Hemoglobin; D006446:Hemoglobin E; C517652:hemoglobin A1c protein, human