ArticleJournal of diabetes science and technology2019
Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision.
Article in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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Who cites it
4 citing papers in PubMed.
- Commercial Translation of Electrochemical Biosensors: Supply Chain Strategy, Scale-Up Manufacturing, and Regulatory-Quality Considerations.Biosensors · 2026Review
- Metal Nanoparticle-Flavonoid Connections: Synthesis, Physicochemical and Biological Properties, as Well as Potential Applications in Medicine.Nanomaterials (Basel, Switzerland) · 2023Review
- Technologies for Diabetes Self-Monitoring: A Scoping Review and Assessment Using the REASSURED Criteria.Journal of diabetes science and technology · 2022Article
- Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197.Journal of diabetes science and technology · 2019Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionBlood 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.
methodsBased 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.
resultsAll 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%.
conclusionAll 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.
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