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首页> 外文期刊>Journal of Diabetes Science and Technology >Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision
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Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision

机译：评估三种血糖监测系统的分析性能：系统准确性，测量重复性和中间测量精度

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Introduction: Blood glucose monitoring systems (BGMS) should provide sufficient analytical quality to allow adequate therapy for diabetes patients. Besides system accuracy, measurement precision is an important aspect of a BGMS’ analytical quality. Methods: Based on ISO 15197:2013/EN ISO 15197:2015, system accuracy, measurement repeatability, and intermediate measurement precision were assessed. ISO 15197:2013 system accuracy criteria require that ?95% of individual BGMS’ test strip lot results shall fall within ±15 mg/dl or ±15% of corresponding comparison method results (at glucose concentrations <100 mg/dl and ?100 mg/dl, respectively), and that ?99% of results fall within consensus error grid (CEG) zones A and B. Measurement repeatability was assessed using venous blood samples, whereas intermediate measurement precision was assessed using control solution samples. Standard deviation (SD) and coefficient of variation (CV) were calculated for glucose concentrations <100 mg/dl and ?100 mg/dl, respectively. Precision acceptance criteria are not specified by ISO 15197:2013. Results: All three BGMS fulfilled system accuracy criteria with 96% to 98% of individual test strip lot’s results falling within the acceptable accuracy limits. All measurement results fell within CEG zones A and B. For measurement repeatability, SD was ?3.3 mg/dl, and CV was ?3.9% for the investigated BGMS. Assessment of intermediate measurement precision showed SD ?1.3 mg/dl and CV ?3.0%. Conclusion: All three BGMS fulfilled system accuracy criteria of ISO 15197:2013. In absence of acceptance criteria, precision results were found to be consistent with the manufacturer’s labeling of the investigated devices.
机译：简介：血糖监测系统（BGMS）应该提供足够的分析质量，以便对糖尿病患者进行适当的治疗。除了系统精度外，测量精度也是BGMS分析质量的重要方面。方法：基于ISO 15197：2013 / EN ISO 15197：2015，评估系统精度，测量重复性和中间测量精度。 ISO 15197：2013系统准确度标准要求，单个BGMS的95％测试条批结果应在±15 mg / dl范围内或相应比较方法结果的±15％范围内（在葡萄糖浓度<100 mg / dl和100 mg时） / dl），并且？99％的结果落在共有误差网格（CEG）区域A和B内。使用静脉血样本评估测量的可重复性，而使用对照溶液样本评估中间的测量精度。分别计算出葡萄糖浓度<100 mg / dl和≤100mg / dl的标准偏差（SD）和变异系数（CV）。 ISO 15197：2013未指定精度验收标准。结果：所有三个BGMS都满足系统精度标准，单个试纸批次结果的96％至98％都在可接受的精度范围内。所有测量结果均位于CEG区域A和B内。对于测量的可重复性，所研究的BGMS的SD为〜3.3 mg / dl，CV为〜3.9％。中间测量精度的评估显示SD≤1.3mg / dl，CV≤3.0％。结论：所有三个BGMS均满足ISO 15197：2013的系统精度标准。在没有接受标准的情况下，发现精确度结果与制造商对被调查设备的标签一致。

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