Overcoming Effects of Interfering Factors in Cell-based NAb Methods

2021

Ruqi Wang, PhD 

Strategies that mitigate interference such as positional effect and matrix effect are critical to improve assay sensitivity and effectively characterizing samples for the presence of neutralizing antibodies (NAb). Eurofins has had success in overcoming these challenges by evaluating plate/signal characteristics and applying a normalization approach. The differences observed between ‘Positive’ and ‘Negative’ samples as determined by NAb assays are oftentimes small and may be unduly influenced by these interfering components within the sample. Such interference may potentially result in a relatively high number of sample characterizations as falsely positive or falsely negative.

A case study from the development of a cell-based method to detect NAb against a therapeutic that functions as an agonist will be presented. In addition, the use of flow cytometry platform on cell-based Nab methods will be discussed.