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[新型HbA(1c)分析仪2.0变体II Turbo(伯乐公司)的评估]

[Evaluation of the new kit HbA(1c) Analyzer 2.0 Variant II Turbo (Bio-Rad)].

作者信息

Meurice Julie, Guillard Emmanuelle, Jaisson Stéphane, Leroy Nathalie, Gillery Philippe

机构信息

CHU de Reims, Laboratoire de Biologie et Recherche Pédiatriques, 45 rue Cognacq-jay 51092 Reims Cedex, France.

出版信息

Ann Biol Clin (Paris). 2011 Sep-Oct;69(5):561-9. doi: 10.1684/abc.2011.0614.

Abstract

The evaluation of glycated hemoglobin (HbA(1c)) is used in daily practice for monitoring the diabetes mellitus. HbA(1c) may be assayed by different methods, among which high-pressure liquid chromatography (HPLC). We have evaluated a new kit 2.0 available on HPLC Variant II(®) Turbo analyzer (Bio-Rad), which is characterized by an elution buffer containing sodium perchlorate. The correlation with the routine method used in our laboratory (HPLC Variant II(®) analyzer equipped with the NU kit) is good (r² = 0.997). Intra- and inter-assay coefficients of variation are respectively lower than 0.6 and 1.6%. Linearity is excellent from 3.2% (11 mmol/mol) to 18.3% (177  mmol/mol). There is no inter-sample contamination. This method provides a result quickly (96  seconds), but does not allow separating labile HbA(1c) from carbamylated hemoglobin, contrary to the NU kit. As the control of analytical quality is a major concern for validation and clinical use of HbA(1c) results, the characteristics of this new kit make it a well-suited tool for daily laboratory practice.

摘要

糖化血红蛋白(HbA₁c)的评估在日常实践中用于监测糖尿病。HbA₁c 可以通过不同方法进行检测,其中包括高压液相色谱法(HPLC)。我们评估了一种可用于HPLC Variant II® Turbo分析仪(伯乐公司)的新型2.0试剂盒,其特点是洗脱缓冲液中含有高氯酸钠。与我们实验室使用的常规方法(配备NU试剂盒的HPLC Variant II®分析仪)的相关性良好(r² = 0.997)。批内和批间变异系数分别低于0.6%和1.6%。线性在3.2%(11 mmol/mol)至18.3%(177 mmol/mol)范围内极佳。不存在样本间污染。该方法能快速得出结果(96秒),但与NU试剂盒不同,它无法将不稳定的HbA₁c与氨甲酰化血红蛋白分离。由于分析质量控制是HbA₁c结果验证和临床应用的主要关注点,这种新型试剂盒的特性使其成为日常实验室实践的合适工具。

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