Residual Safety Margin-Based Risk Stratification for Hospital-Wide POCT Glucose Meters Anchored to ISO 15197: Moving Beyond Pass-Fail.

ABSTRACT: Background: In this hospital-wide evaluation of point-of-care testing (POCT) glucose meters, we introduced a residual safety margin (r) anchored to ISO 15197:2013 thresholds to quantify tolerance, move beyond binary pass/fail assessments, and enable risk stratification. Methods: Thirty-five departmental glucose meters were compared with a central laboratory reference at five predefined glucose concentrations. Compliance was assessed using ISO 15197:2013 point-wise limits, Bland-Altman analysis was used to estimate bias and limits of agreement, and the mean absolute relative difference (MARD) and root mean square error (RMSE) were calculated to summarize overall error. At each concentration, r was calculated for every department, ranked, and classified into low,

SUBMITTER: Bi H 

PROVIDER: S-EPMC12731778 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature