Lot-to-lot reagent verification: Effect of sample size and replicate measurement on linear regression approaches.

• Reagent verification may use ordinary least squares or Deming regressions. • Weighted forms of regression better detected lot-to-lot bias than unweighted forms. • Larger sample sizes and more replicates improve bias detection capability. • Effect of sample size and replicates depends on range ratios and assay imprecision. • Laboratories should tailor verification protocols balanced with assay performance. We investigate the simulated impact of varying sample size and replicate number using ordinary least squares (OLS) and Deming regression (DR) in both weighted and unweighted forms, when applied to paired measurements in lot-to-lot verification. Simulation parameter investigated in this study were: range ratio, analytical coefficient of variation, sample size, replicates, alpha (level of significance) and constant and proportional biases. For each simulation scenario, 10,000 iterations were performed, and the average probability of bias detection was determined. Generally, the weighted forms of regression significantly outperformed the unweighted forms for bias detection. At the low range ratio (1:10), for both weighted OLS and DR, improved bias detection was observed with greater number of replicates, than increasing the number of comparison samples. At the high range ratio (1:1000), for both weighted OLS and DR, increasing the number of replicates above two is only slightly more advantageous in the scenarios examined. Increasing the numbers of comparison samples resulted in better detection of smaller biases between reagent lots. The results of this study allow laboratories to determine a tailored approach to lot-to-lot verification studies, balancing the number of replicates and comparison samples with the analytical performance of measurement procedures involved. [ABSTRACT FROM AUTHOR]