A major challenge for flow cytometry assays supporting clinical trials is post-collection sample stability. Here we present an approach that mitigates the stability issue while preserving sample integrity and cellular markers, even when enumerating rare populations. In this method, we demonstrate how freezing of lysed whole blood preserves sample integrity and prolongs sample stability for Tregs percentage, absolute cell count, and median fluorescent intensity values up to 12 days while stored at -80°C, as compared to 3 days at room temperature. This lyse-freeze method is associated with logistical and cost-effective advantages to both sponsors and CROs and allows for ease of sample batch processing during clinical study sample analysis.
Upon completion, participant will be able to recognize a challenge that encompasses the development of clinical flow cytometry assays, especially the assays that involve rare populations such as Tregs
Upon completion, participant will be able to demonstrate that flow cytometry assays can effectively enumerate Treg populations which play an important role towards the success of Treg-based clinical studies.
Upon completion, participant will be able to appreciate the logistical advantages and cost-effectiveness that can be gained when using lyse-freeze methods that allow for extending stability of flow cytometry samples