血糖自我监测改进系统的系统准确性和用户性能评估
System Accuracy and User Performance Evaluation of an Improved System for Self-Monitoring of Blood Glucose.
作者信息
Baumstark Annette, Jendrike Nina, Liebing Christina, Haug Cornelia, Freckmann Guido
机构信息
1 Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
出版信息
J Diabetes Sci Technol. 2018 Mar;12(2):407-411. doi: 10.1177/1932296817752958. Epub 2018 Jan 1.
Abstract
An improved test cassette for the integrated Accu-Chek® Mobile system (Roche Diabetes Care GmbH, Mannheim, Germany) has been developed. System accuracy of this improved system was evaluated based on ISO 15197:2013, clause 6.3, for three reagent system lots. According to this standard, at least 95% of the system's measurement results shall be within ±15 mg/dL and ±15% of the results of the comparison method at glucose concentrations <100 mg/dL and ≥100 mg/dL (accuracy criterion A), respectively, and at least 99% of results shall be within consensus error grid zones A and B (accuracy criterion B). In addition, accuracy was evaluated in the hands of users based on ISO 15197:2013, clause 8, with one reagent system lot.
摘要
已开发出一种用于集成式Accu-Chek® Mobile系统（德国曼海姆罗氏糖尿病护理有限公司）的改进型测试盒。基于ISO 15197:2013第6.3条，对三个试剂系统批次评估了这种改进系统的系统准确性。根据该标准，在葡萄糖浓度<100 mg/dL和≥100 mg/dL时，系统测量结果中至少95%应分别在比较方法结果的±15 mg/dL和±15%范围内（准确性标准A），并且至少99%的结果应在一致性误差网格区域A和B内（准确性标准B）。此外，基于ISO 15197:2013第8条，使用一个试剂系统批次在用户手中评估了准确性。
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