Strategy for Assessing Stability in Multiplexed Cytokine Panels

Clinical trials requiring analysis of more than one biomarker can greatly benefit from implementation of multiplex biomarker panels. This is a key strategy for pediatric studies, studies with limited sample volumes, or early phase studies exploring diverse drug effects. However, there are challenges associated with developing and validating these methods. Parameters that are particularly challenging for multiplex panels are the assessment of parallelism and evaluation of analyte stability. It can be difficult to source samples with either high or low concentrations of all analytes across the panel and oftentimes these experiments are performed by using samples with spiked reference material as a surrogate which is not ideal due to potential discordance between recombinant kit calibrators and endogenous proteins. In this presentation, these challenges will be discussed, along with strategies for conducting stability using ex-vivo stimulation of whole blood and sample admixing to better assess stability during method validation.