[Atellica®DCA分析仪(Siemens Healthineers)在护理点检测HbA1c的分析性能评价]。

IF 0.4
Emmanuelle Guillard, Audrey Mourlin, Dany Mendes, Nathalie Leroy, Laetitia Florent, Philippe Gillery, Stéphane Jaisson
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引用次数: 0

摘要

糖化血红蛋白(HbA1c)在糖尿病患者治疗监测中的重要性需要使用强大而有效的检测方法,特别是在护理点检测中。本研究评估了西门子Healthineers Atellica®DCA的分析性能。通过线性度和精密度分析,将结果与DCA Vantage (Siemens)和capillys 3 Tera (Sebia,毛细管电泳)的结果进行比较。还评估了主要干扰因素(甘油三酯和胆红素)和总血红蛋白浓度的影响。试验结果表明,HbA1c在4.5% ~ 14%范围内具有良好的线性关系,变异系数在1.42 ~ 2.33%范围内具有良好的精度。与毛细管电泳和Atellica®DCA的相关性极好(r²= 0.991和r²= 0.994)。结果的准确性,与外部质量样品评估,也令人满意。该方法对高达10mmol /L的高甘油三酯血症或高达432 μmol/L的高胆红素血症的干扰不敏感,即使对低浓度的总血红蛋白(低至57.5 g/L)也提供可靠的结果。Atellica®DCA还提供了改进的人体工程学,具有用户友好的触摸屏,可以连接到实验室的管理软件。该分析仪的分析性能适合作为即时检测分析仪使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Evaluation of the analytical performances of the Atellica® DCA analyzer (Siemens Healthineers) for point of care determination of HbA1c].

The importance of HbA1c in the therapeutic monitoring of diabetic patients requires the use of robust and efficient assay methods, especially for point-of-care testing. This study evaluates the analytical performances of the Siemens Healthineers Atellica® DCA. After analyzing linearity and precision, the results were compared with those of the DCA Vantage (Siemens) and the Capillarys 3 Tera (Sebia, capillary electrophoresis). The main interferences (triglycerides and bilirubin) and the effect of total hemoglobin concentration were also assessed. The tests showed a good linearity over a range of 4.5 to 14 % HbA1c, and good precision with coefficients of variation ranging from 1.42 to 2.33 %. The correlation with capillary electrophoresis and the Atellica® DCA was excellent (r² = 0.991 and r² = 0.994, respectively). The accuracy of the results, assessed with external quality samples, was also satisfactory. The method is not sensitive to interference of hypertriglyceridemia up to 10 mmol/L or hyperbilirubinemia (up to 432 μmol/L), and provides reliable results even for low concentrations of total hemoglobin (down to 57,5 g/L). The Atellica® DCA also offers improved ergonomics, with a user-friendly touchscreen and can be connected to the laboratory's management software. this analyzer presents analytical performances suitable for use as point-of-care testing analyzer.

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