Jul 02, 2025
Malaria RDT Clinical Performance and Usability Evaluation Resources
- PATH Malaria Diagnostics1
- 1PATH
- PATH Malaria Diagnostics
Collection Citation: PATH Malaria Diagnostics 2025. Malaria RDT Clinical Performance and Usability Evaluation Resources. protocols.io https://dx.doi.org/10.17504/protocols.io.261gekpxdg47/v1
License: This is an open access collection distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this collection and it's working
Created: July 02, 2025
Last Modified: July 02, 2025
Collection Integer ID: 221454
Keywords: malaria rdt clinical performance, malaria rapid diagnostic test, comprehensive clinical study protocol, comprehensive clinical study protocol for study, clinical performance, usability evaluation, usability evaluation resource, rdt, study design, evaluation, malaria, rapid diagnostic test
Funders Acknowledgements:
Gates Foundation
Grant ID: INV-071824
Disclaimer
This protocol template is provided by PATH for informational and educational purposes only. PATH does not assume any responsibility or liability for studies that adopt or modify this template. Investigators and sponsors are solely responsible for ensuring that any clinical study using this template complies with applicable laws, regulations, institutional policies, and ethical standards. This template is not intended to replace regulatory guidance or formal clinical development planning. Protocols intended to generate data for regulatory submissions must be developed within a comprehensive clinical plan that is aligned with applicable regulatory requirements.
Abstract
This is a template protocol for a clinical performance and usability evaluation of one or more malaria rapid diagnostic tests (RDTs). Resources associated with the protocol are also provided. The goal of this template is to assist researchers, manufacturers, and investigators in developing a comprehensive clinical study protocol for studies of this nature and in considering key assumptions and elements of study design, planning, and execution. This work was supported by a grant from the Gates Foundation (INV-071824).
Troubleshooting
This protocol template is provided by PATH for informational and educational purposes only. PATH does not assume any responsibility or liability for studies that adopt or modify this template. Investigators and sponsors are solely responsible for ensuring that any clinical study using this template complies with applicable laws, regulations, institutional policies, and ethical standards. This template is not intended to replace regulatory guidance or formal clinical development planning. Protocols intended to generate data for regulatory submissions must be developed within a comprehensive clinical plan that is aligned with applicable regulatory requirements.
Files
TEMPLATE_PROTOCOL_mRDT clinical performance and usability evaluation_v1.0_June 2025.docx