一种新型糖化血红蛋白酶法检测的分析性能

Analytical performances of a new enzymatic assay for hemoglobin A1c.

作者信息

Jaisson Stéphane, Desmons Aurore, Renard Benoît, Chevelle Benjamin, Leroy Nathalie, Gillery Philippe

机构信息

Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, France.

出版信息

Clin Chim Acta. 2014 Jul 1;434:48-52. doi: 10.1016/j.cca.2014.04.008. Epub 2014 Apr 24.

DOI:10.1016/j.cca.2014.04.008

PMID:24768786

Abstract

BACKGROUND

HbA1c is considered the gold standard for the follow-up of diabetic patients and a new diagnostic tool for diabetes mellitus, which implies the availability of reliable assay methods. We have evaluated a new assay developed by Abbott Laboratories, based on the enzymatic quantification of HbA1c by a fructosyl dipeptide oxidase using Architect analyzers.

METHODS

Precision, linearity, correlation with a HPLC method, accuracy and potential impact interferences on HbA1c measurement have been evaluated.

RESULTS

Intra-day and between-day CVs were lower than 1.2% and linearity was excellent from 19 mmol/mol (3.9%) to 163 mmol/mol (17.1%). The results were well correlated with those obtained by the HPLC (Variant II device, kit NU - BioRad): HbA1c [Architect, mmol/mol]=0.986×HbA1c [Variant II, mmol/mol]+0.713 (r=0.998, n=109). This method provided consistent results with IFCC titrated quality control samples. Classical interferences in HbA1c assays (i.e. labile HbA1c, carbamylated hemoglobin, triglycerides or bilirubin) did not have an impact on HbA1c quantification by this method.

CONCLUSION

This new enzymatic assay proved to be a robust and reliable method for HbA1c measurement suitable for routine practice in clinical chemistry laboratories.

摘要

背景

糖化血红蛋白（HbA1c）被认为是糖尿病患者随访的金标准以及糖尿病的一种新诊断工具，这意味着需要有可靠的检测方法。我们评估了雅培实验室开发的一种新检测方法，该方法基于使用Architect分析仪通过果糖基二肽氧化酶对HbA1c进行酶定量。

方法

评估了精密度、线性、与高效液相色谱法的相关性、准确性以及对HbA1c测量的潜在影响干扰。

结果

日内和日间变异系数低于1.2%，线性在19 mmol/mol（3.9%）至163 mmol/mol（17.1%）范围内极佳。结果与通过高效液相色谱法（Variant II设备，试剂盒NU - BioRad）获得的结果高度相关：HbA1c [Architect，mmol/mol]=0.986×HbA1c [Variant II，mmol/mol]+0.713（r = 0.998，n = 109）。该方法与国际临床化学和检验医学联合会（IFCC）滴定的质量控制样品结果一致。HbA1c检测中的经典干扰因素（即不稳定的HbA1c、氨甲酰化血红蛋白、甘油三酯或胆红素）对该方法的HbA1c定量没有影响。