HbE 杂合子对 HbA1c 测量的影响。

Effect of HbE heterozygosity on the measurement of HbA1c.

机构信息

Department of Pathology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

出版信息

Pathology. 2013 Jun;45(4):417-9. doi: 10.1097/PAT.0b013e32836142eb.

DOI:10.1097/PAT.0b013e32836142eb

PMID:23635828

Abstract

AIM

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.

METHODS

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%.

RESULTS

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.

CONCLUSION

Laboratories should be cautious when evaluating HbA1c results in the presence of haemoglobin variants.

摘要

目的

HbA1c 的测量为糖尿病患者的血糖控制提供了极好的衡量标准。然而，已知血红蛋白（Hb）变体可干扰 HbA1c 的分析。在我们的实验室中，HbA1c 的测量是通过 Variant II turbo 2.0 进行的。本研究旨在探讨 HbE 特征对 HbA1c 分析的影响。

方法

在一个月内，我们实验室对 3522 个样本中的 93 个样本进行了 HbA1c 分析，以确定 HbA1c 分析中的 HbE 特征。在 93 个样本中，有 81 个样本的血红蛋白分析确定为 HbE 特征。为了确定 HbE 特征对 Variant II Tubo 2.0 分析 HbA1c 的影响，使用硼酸盐亲和高效液相色谱（HPLC）法（Primus PDQ）作为比较方法。进行了两阶段线性回归分析、Bland Altman 图和 Deming 回归分析，以分析 HbE 特征的存在是否导致结果产生统计学上显著的差异。皇家澳大利亚病理学家学院（RCPA）外部质量保证的 HbA1c 总允许误差为 5%。因此，在 6%和 9%的医学决策水平上，超过 5%的临床显著差异。