A role for Biofoundries in rapid development and validation of automated SARS-CoV-2 clinical diagnostics

Michael A. Crone, Miles Priestman, Marta Ciechonska, Kirsten Jensen, David J. Sharp, Arthi Anand, Paul Randell, Marko Storch and Paul S. Freemont ()
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Michael A. Crone: Imperial College Translation and Innovation Hub
Miles Priestman: Imperial College Translation and Innovation Hub
Marta Ciechonska: Imperial College Translation and Innovation Hub
Kirsten Jensen: Imperial College Translation and Innovation Hub
David J. Sharp: Imperial College London
Arthi Anand: North West London Pathology
Paul Randell: North West London Pathology
Marko Storch: Imperial College Translation and Innovation Hub
Paul S. Freemont: Imperial College Translation and Innovation Hub

Nature Communications, 2020, vol. 11, issue 1, 1-11

Abstract: Abstract The SARS-CoV-2 pandemic has shown how a rapid rise in demand for patient and community sample testing can quickly overwhelm testing capability globally. With most diagnostic infrastructure dependent on specialized instruments, their exclusive reagent supplies quickly become bottlenecks, creating an urgent need for approaches to boost testing capacity. We address this challenge by refocusing the London Biofoundry onto the development of alternative testing pipelines. Here, we present a reagent-agnostic automated SARS-CoV-2 testing platform that can be quickly deployed and scaled. Using an in-house-generated, open-source, MS2-virus-like particle (VLP) SARS-CoV-2 standard, we validate RNA extraction and RT-qPCR workflows as well as two detection assays based on CRISPR-Cas13a and RT-loop-mediated isothermal amplification (RT-LAMP). In collaboration with an NHS diagnostic testing lab, we report the performance of the overall workflow and detection of SARS-CoV-2 in patient samples using RT-qPCR, CRISPR-Cas13a, and RT-LAMP. The validated RNA extraction and RT-qPCR platform has been installed in NHS diagnostic labs, increasing testing capacity by 1000 samples per day.

Date: 2020
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DOI: 10.1038/s41467-020-18130-3

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