It is widely acknowledged that dilution linearity and/or parallelism should be performed early in method development of biomarker ligand-binding assays. These assessments yield substantial information on the performance of an assay, most notably, selectivity, minimal required dilution (MRD) and possible matrix interference. While consensus has been reached on the necessity to assess dilution linearity and/or parallelism, the difference between both terms still causes confusion amongst the scientific community. During this Rapid Fire presentation, the differences between dilution linearity and parallelism will be discussed with a focus on the critical information obtained by each method when used in biomarker assay development/validation. Dilution linearity and parallelism results from different methods will be showcased, highlighting situations where parallelism data acquired, after an initial dilution linearity experiment, increased confidence in biomarker validation and study-related data. This presentation will emphasize the importance of performing parallelism assessments to meet the current needs in biomarkers assay development.
Learning Objectives:
Participant will be able to distinguish the difference between dilution linearity and parallelism.
Participant will be able to decide which approach (Parallelism/ Dilution Linearity) is better for their method.
Participant will understand better why parallelism data is critical to have good confidence in a biomarker assay.