Evidence-based extension of reagent shelf-life beyond expiry using patient-based moving averages, westgard sigma rules, and CLSI EP25

The combination of Westgard sigma rules, EP25, and simulation-optimized MA provides a reproducible, data-driven framework for post-expiry reagent stability assessment. Optimizing MA with real patient data enhances detection performance, bridging theoretical quality-control design and routine laboratory application. This integrated approach enables laboratories to make scientifically justified, cost-effective decisions regarding reagent reuse beyond manufacturer expiry dates.