Measuring precision in bioassays: Rethinking assay validation.

ABSTRACT: The m:n:θ_b procedure is often used for validating an assay for precision, where m levels of an analyte are measured with n replicates at each level, and if all m estimates of coefficient of variation (CV) are less than θ_b , then the assay is declared validated for precision. The statistical properties of the procedure are unknown so there is no clear statistical statement of precision upon passing. Further, it is unclear how to modify the procedure for relative potency assays in which the constant standard deviation (SD) model fits much better than the traditional constant CV model. We use simple normal error models to show that under constant CV across the m levels, the probability of passing when the CV is θ_b is about 10% to 20% for some recommended imple

SUBMITTER: Fay MP 

PROVIDER: S-EPMC5771887 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature