Improved Statistical Methods for Evaluation of Stability of In Vitro Diagnostic Reagents

In Vitro diagnostic (IVD) reagent stability is typically evaluated using regression analysis of measurand drift across time following CLSI guideline EP25-A. The corresponding stability duration establishment has several limitations. The stability duration conclusion is based on a two-stage acceptance criteria using the p-value of the regression slope followed by the 95% confidence interval (CI) on the fitted regression line if the p-value 2016). Monte Carlo simulation studies are presented to illustrate the improved statistical properties of the current proposal along with an example power analysis for study design.