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对多种血糖监测系统中试纸性能的全面评估。

A comprehensive evaluation of strip performance in multiple blood glucose monitoring systems.

作者信息

Katz Laurence B, Macleod Kirsty, Grady Mike, Cameron Hilary, Pfützner Andreas, Setford Steven

机构信息

LifeScan Inc., 965 Chesterbrook Blvd, Wayne, PA 19087, USA.

出版信息

Expert Rev Med Devices. 2015 May;12(3):263-71. doi: 10.1586/17434440.2015.1019469. Epub 2015 Feb 21.

Abstract

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch(®) VerioVue™ met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting. Performance of OneTouch(®) Verio IQ™, OneTouch(®) Verio Pro™, OneTouch(®) Verio™, OneTouch(®) VerioVue™ and Omni Pod each met or exceeded accuracy standards for user performance and system accuracy in a clinical setting set forth in ISO15197:2013(E).

摘要

准确的血糖自我监测是有效血糖控制自我管理的关键组成部分。最佳胰岛素剂量调整和低血糖检测需要准确的血糖自我监测结果。然而,血糖监测系统可能会受到试纸条、用户、环境和药物因素导致的误差影响。本报告根据ISO15197:2013(E)中的指南,评估了5种均使用Verio血糖试纸条的血糖监测系统在实验室检测中的精密度、血细胞比容影响和干扰情况,以及普通用户使用情况和临床检测中的系统准确性。在实验室环境中,OneTouch(®) VerioVue™的性能达到或超过了ISO15197:2013中规定的精密度、血细胞比容性能和干扰测试标准。在临床环境中,OneTouch(®) Verio IQ™、OneTouch(®) Verio Pro™、OneTouch(®) Verio™、OneTouch(®) VerioVue™和Omni Pod的性能均达到或超过了ISO15197:2013(E)中规定的用户使用情况和系统准确性的准确性标准。

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