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Hindi Letter to Editor
Accuracy Evaluation of a Blood Glucose Meter System for Self-Testing with Three Strip Lots Following ISO 15197:2013 and EN ISO 15197:2015
Abstract
Standardized verification of blood glucose monitoring systems meeting analytical and clinical accuracy requirements is essential for regulatory, clinical, comparative purchasing and post-launch surveillance purposes. ISO 15197:2013 and the European harmonized version EN ISO 15197:2015 [1] outline acceptable minimum accuracy performance criteria for blood glucose monitoring systems for selftesting (SMBG). For compliance, 95% of the results from each of 3 lots of strips must be within either ± 15 mg/dl of the average measured values of the comparison method at blood glucose concentrations <100 mg/dl or within ± 15% for concentrations ≥ 100 mg/dl. In addition, 99% of the system’s blood glucose results must fall within zones A and B of consensus error grid analysis.
