DetectEV: a functional enzymatic assays to predict the potency of extracellular vesicles

The applications of extracellular vesicles (EVs) as therapeutics or nanocarriers for cell-free therapies necessitates a comprehensive assessment of their bioactivity, batch-to-batch reproducibility, and stability. Due to the considerable heterogeneity in EV preparations, there is a crucial need for a sensitive functional test to complement established methods for EV characterization. In this study, we introduce the detectEVs assay, an enzymatic-based approach designed to evaluate EV bioactivity. Specifically, this assay enables quantitative measurement of both EV bioactivity and integrity in small-size EV samples through a single-step analysis. Moreover, the detectEV assay proves effective for quality checking EVs post-isolation, during storage, and loading processes. The development and validation of this robust and straightforward test were extended to EVs from different cell lines and hold promise for enhancing the characterization of EVs, thereby enabling the prediction of their potency. ![Figure][1] ### Competing Interest Statement The authors have declared no competing interest. [1]: pending:yes