Aim: Current blood monitoring methods require sample collection and testing at a central lab, which can take days. Point of care (POC) devices with quick turnaround time can provide an alternative with faster results, allowing for real-time data leading to better treatment decisions for patients. Results/Methodology: An assay to measure monoclonal antibody therapeutic-A was developed on two POC devices. Data generated using 75 serum samples (65 clinical & ten spiked samples) show correlative results to the data generated using Gyrolab technology. Conclusion: This case study uses a monoclonal antibody therapeutic-A concentration assay as an example to demonstrate the potential of POC technologies as a viable alternative to central lab testing with quick results allowing for real-time decision-making.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 12, No. 20

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History

Received 12 July 2020

Accepted 10 September 2020

Published online 25 September 2020

Published in print October 2020

Information

Keywords

Acknowledgments

Editorial assistance was provided by Anshin Biosolutions Corp, funded by Genentech.

Financial & competing interests disclosure

Funding for this work was provided by Genentech, Inc. SK Fischer and K Williams are employees of Genentech, Inc., and stockholders of the Roche group. H Xu, E Capio and M Briman are employees and stockholders of Proxim Diagnostics, Corp. Bryan Bothwell and Ian Harmon are employees and stockholders of Qorvo Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

All procedures performed in studies involving human participants were in accordance with the principles outlined in the Declaration of Helsinki. In addition, appropriate consent was obtained from the participants involved.

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