Process Optimization For Assays: A Framework For Controlling Variability And Optimizing Assay Performance

By Nathaniel G. Hentz, PhD, Artel, Inc.

Employing a process optimization approach to assay development involves breaking down the assay workflow into smaller modules, such as a mixing step or a reagent addition step, and then measuring and optimizing each module individually using MVS technology. Once the assay is optimized to its fullest extent, the biology is incorporated for the final phase.

Scientists are finding optimization is particularly helpful in two types of COVID-19 assays – RT-PCR and ELISA. Variability can be introduced to RT-PCR assays, especially considering small volume transfer or the use of a viscous master mix. ELISA results can be affected at multiple places throughout the assay workflow: liquid dispense variability can compound across multiple liquid handling steps, inefficient plate washing leads to high variability or inappropriate mixing can lead to erratic results. Whether you are running COVID-19 analytical workflows for diagnostics, therapeutics, or vaccines, by applying process optimization throughout the assay workflow, you can improve overall assay performance.