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使用参考物质评估台式实验室血糖仪的准确性和精密度。

Evaluation of Trueness and Precision of a Bench-Top Laboratory Glucose Analyzer Using Reference Materials.

机构信息

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

Dr. Müller Gerätebau GmbH, Freital, Germany.

出版信息

J Diabetes Sci Technol. 2022 May;16(3):751-755. doi: 10.1177/1932296821991216. Epub 2021 Feb 8.

Abstract

SUPER GL compact is a bench-top analyzer for glucose, lactate, and hemoglobin concentrations. Glucose measurements in the biosensor are based on an enzymatic-amperometric reaction of glucose with glucose oxidase.In this study, trueness and precision were assessed with Standard Reference Material 965b (National Institute of Standards and Technology, Gaithersburg, MD) for 2 SUPER GL compact (S1 and S2) and 1 YSI 2300 STAT Plus (Y) device, using a protocol based on CLSI EP05-A3.Precision was similar among S1, S2, and Y. S1 and S2 exhibited negative bias at low concentrations and positive bias at high concentrations, whereas Y showed negative bias that increased with higher concentrations. Overall, SUPER GL compact's performance was comparable to that of YSI 2300 STAT Plus.

摘要

SUPER GL compact 是一款台式分析器,可用于测量葡萄糖、乳酸和血红蛋白浓度。生物传感器中的葡萄糖测量基于葡萄糖与葡萄糖氧化酶的酶促电流反应。在这项研究中,使用基于 CLSI EP05-A3 的协议,使用标准参考物质 965b(美国国家标准与技术研究院,马里兰州盖瑟斯堡)对 2 台 SUPER GL compact(S1 和 S2)和 1 台 YSI 2300 STAT Plus(Y)设备进行了准确性和精密度评估。S1、S2 和 Y 的精密度相似。S1 和 S2 在低浓度时表现出负偏差,在高浓度时表现出正偏差,而 Y 则表现出随着浓度升高而增加的负偏差。总体而言,SUPER GL compact 的性能与 YSI 2300 STAT Plus 相当。

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