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Development and validation of methods that enable high-quality droplet digital PCR and hematological profiling data from microvolume blood samples: Supplementary tables

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posted on 2022-11-04, 10:39 authored by Bin Xu, Ryan Haley

Aim: Mouse models have been crucial to preclinical studies in the increasingly relevant fields of cell and

gene therapy. However, only small quantities of mouse blood can be collected without producing adverse

physiological effects that compromise data integrity. Results: To address this limitation, two combined

methods were developed to create detailed droplet digital PCR (ddPCR) and hematological profiles using

only ∼20 μl of mouse blood. The validation of these methods, which can serve as a foundation for a

standardized regulatory pipeline for ddPCR, is discussed. Even when using small amounts of input, this

ddPCR protocol is accurate, precise, selective, specific, stable and robust. Conclusion: These techniques

enable more frequent sample collection for higher-resolution pharmacokinetic data that meets or exceeds

quality standards.

Funding

The authors are employed by and receive compensation from a company that is involved in the development and validation of droplet digital PCR and quantitative PCR methods. This company also provided funding for the QX200 Droplet Digital PCR system (Bio-Rad, CA, USA), the HemaVet 950FS Hematological Analyzer (Drew Scientific, FL, USA) and all materials and reagents required for the performance of droplet digital PCR and hematological analysis. However, the views and conclusions presented in this paper are those of the authors and do not necessarily reflect those of the company. The authors declare no advisory positions, board memberships or patent holdings that are related to the topic of this article or that would compromise the integrity or impartiality of this work.

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