用于糖化血红蛋白（HbA 1c）检测的DCA Vantage分析仪的评估。

Evaluation of the DCA Vantage analyzer for HbA 1c assay.

作者信息

Szymezak Jean, Leroy Nathalie, Lavalard Emmanuelle, Gillery Philippe

机构信息

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

出版信息

Clin Chem Lab Med. 2008;46(8):1195-8. doi: 10.1515/CCLM.2008.228.

DOI:10.1515/CCLM.2008.228

PMID:18588431

Abstract

BACKGROUND

Measurement of HbA 1c is key in monitoring diabetic patients in both laboratories and clinical units, where HbA 1c results are used as part of patient education.

METHODS

We have evaluated the DCA Vantage, a new device for immunological assay of HbA 1c. HbA 1c results obtained were evaluated in terms of precision, linearity, specificity and practicability, and were compared with results obtained by a Variant II HPLC method.

RESULTS

The method exhibited intra- and inter-assay coefficients of variation lower than 2.6% and 4.0%, respectively, and good correlation with the comparison HPLC method (r2=0.9776). No interference was noted in the presence of labile HbA 1c or carbamylated hemoglobin. The new device exhibited improved practicability characteristics and allowed better sample identification, better management of quality control routines and greater connectivity possibilities compared to the previous DCA 2000 analyzer.

CONCLUSIONS

This new analyzer exhibited analytical and practical characteristics very suitable for HbA 1c assay for laboratory or point-of-care use according to good laboratory practice.

摘要

背景

糖化血红蛋白（HbA₁c）的检测在实验室和临床科室对糖尿病患者的监测中至关重要，其中HbA₁c检测结果被用作患者教育的一部分。

方法

我们评估了一种用于HbA₁c免疫分析的新设备DCA Vantage。从精密度、线性、特异性和实用性方面对获得的HbA₁c检测结果进行评估，并与采用Variant II高效液相色谱法获得的结果进行比较。

结果

该方法的批内和批间变异系数分别低于2.6%和4.0%，与比较的高效液相色谱法具有良好的相关性（r² = 0.9776）。在存在不稳定HbA₁c或氨甲酰化血红蛋白的情况下未观察到干扰。与之前的DCA 2000分析仪相比，新设备具有更好的实用性特点，能实现更好的样本识别、更完善的质量控制程序管理以及更强的连接可能性。