Measurement of HbA1c and HbA2 by Capillarys 2 Flex Piercing HbA1c programme for simultaneous management of diabetes and screening for thalassemia.

Peifeng Ke,Junhua Zhuang,Jianhua Xu,Xiaobin Wu,Li Lin,Jiawei Liu,Yan Chao,Zemin Wan,Xianzhang Huang,Xinzhong Wu,Yujuan Xiong

doi:10.11613/bm.2017.030704

Abstract

IntroductionThalassemia could interfere with some assays for haemoglobin A1c (HbA1c) measurement, therefore, it is useful to be able to screen for thalassemia while measuring HbA1c. We used Capillarys 2 Flex Piercing (Capillarys 2FP) HbA1c programme to simultaneously measure HbA1c and screen for thalassemia.Materials and methodsSamples from 498 normal controls and 175 thalassemia patients were analysed by Capillarys 2FP HbA1c programme (Sebia, France). For method comparison, HbA1c was quantified by Premier Hb9210 (Trinity Biotech, Ireland) in 98 thalassaemia patients samples. For verification, HbA1c from eight thalassaemia patients was confirmed by IFCC reference method.ResultsAmong 98 thalassaemia samples, Capillarys 2FP did not provide an HbA1c result in three samples with HbH due to the overlapping of HbBart’s with HbA1c fraction; for the remaining 95 thalassaemia samples, Bland-Altman plot showed 0.00 ± 0.35% absolute bias between two systems, and a significant positive bias above 7% was observed only in two HbH samples. The HbA1c values obtained by Capillarys 2FP were consistent with the IFCC targets (relative bias below ± 6%) in all of the eight samples tested by both methods. For screening samples with alpha (α-) thalassaemia silent/trait or beta (β-) thalassemia trait, the optimal HbA2 cut-off values were ≤ 2.2% and > 2.8%, respectively.ConclusionsOur results demonstrated the Capillarys 2FP HbA1c system could report an accurate HbA1c value in thalassemia silent/trait, and HbA2 value (≤ 2.2% for α-thalassaemia silent/trait and > 2.8% for β-thalassemia trait) and abnormal bands (HbH and/or HbBart’s for HbH disease, HbF for β-thalassemia) may provide valuable information for screening.

Highlights

Thalassemia could interfere with some assays for haemoglobin A1c (HbA1c) measurement, it is useful to be able to screen for thalassemia while measuring HbA1c
The HbA1c values obtained by Capillarys 2FP were consistent with the IFCC targets in all of the eight samples tested by both methods
Our results demonstrated the Capillarys 2FP HbA1c system could report an accurate HbA1c value in thalassemia silent/trait, and HbA2 value (≤ 2.2% for α-thalassaemia silent/trait and > 2.8% for β-thalassemia trait) and abnormal bands (HbH and/or HbBart’s for HbH disease, HbF for β-thalassemia) may provide valuable information for screening

Summary

Introduction

Thalassemia could interfere with some assays for haemoglobin A1c (HbA1c) measurement, it is useful to be able to screen for thalassemia while measuring HbA1c. We used Capillarys 2 Flex Piercing (Capillarys 2FP) HbA1c programme to simultaneously measure HbA1c and screen for thalassemia. Haemoglobin A1c (HbA1c), the major form of all glycated haemoglobin species, is produced by the non-enzymatic addition of glucose residues to valine moieties at the N-terminal end of the haemoglobin (Hb) β-chain [1]. HbA1c provides an estimate of blood glucose concentrations over a normal erythrocyte lifespan, and any conditions altering erythrocyte survival (e.g., haemolytic anaemia, iron deficiency anaemia or haemoglobinopathies) may lead to misinterpretation of the HbA1c result and misdiagnosis and mistreatment [7]. Thalassemia is the most common monogenetic disease caused by defects in the synthesis of one or more of the haemoglobin chains [8,9].

Methods

Results

Conclusion