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A Proposal for Increasing Speed of Validating SARS-CoV-2 Diagnostic Tests

Published onNov 27, 2020
A Proposal for Increasing Speed of Validating SARS-CoV-2 Diagnostic Tests

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Abstract:

Rapid access to diagnostics for emerging high priority pathogens is of great importance from a clinical, public health and economic point of view. Currently in the United States there are several technological, regulatory and organisational improvements that might be adopted for the COVID-19 and future pandemics; In this article, we suggest a proposal for increasing the speed of validating SARS-CoV-2 diagnostic tests, suggestions include: a structured EUA data submission process, distributed FDA directed CLIA led validation, and building an open source synthetic patient clinical sample panel. This document is a work in progress, containing some ideas which may be of value to consider and implement. We welcome you to add your name to this proposal or make a contribution of any size and scope. This concept and paradigm will be of utmost importance especially if a new mutant strain begins circulating that evades current diagnostics and vaccines.

Full proposal details can be found here:

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