TL18: Analytical studies in In Vitro Diagnostics
*Yuqun Abigail Luo, FDA\CBER 


There are in vitro assays regulated by FDA but also in vitro lab assessments are a part of just about all clinical trials. The analytical properties of these assays are critical but pose interesting statistical challenges. This session will discuss the complexity of precision studies including estimating variability in multivariate assays and estimating limit of detection and issues of method comparisons.