Rapid implementation and validation of a cold-chain free SARS-CoV-2 diagnostic testing workflow to support surge capacity

Andrew Bosworth, Celina Whalley, Charlie Poxon, Kasun Wanigasooriya, Oliver Pickles, Erin L. Aldera, Danai Papakonstantinou, Gabriella L. Morley, Eloise M. Walker, Agnieszka E. Zielinska, Dee McLoughlin, Craig Webster, Tim Plant, Andrew Ellis, Alex Richter, Michael Kidd, Andrew D. Beggs*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)

Abstract

Background: In January 2020 reports of unidentified severe respiratory illness were described in Wuhan, China. A rapid expansion in cases affecting most countries around the globe led to major changes in the way people live their daily lives. In the United Kingdom, the Department of Health and Social Care directed healthcare providers to establish additional resources to manage the anticipated surge in cases that could overwhelm the health services. A priority area was testing for SARS-CoV-2 RNA and its detection by qualitative RT-PCR. Design: A laboratory workflow twinning research environment with clinical laboratory capabilities was implemented and validated in the University of Birmingham within 4 days of the project initiation. The diagnostic capability was centred on an IVD CE-marked RT-PCR kit and designed to provide surge capacity to the nearby Queen Elizabeth Hospital. The service was initially tasked with testing healthcare workers (HCW) using throat swabs, and subsequently the process investigated the utility of using saliva as an alternative sample type. Results: Between the 8th April 2020 and the 30th April 2020, the laboratory tested a total of 1282 HCW for SARS-CoV-2 RNA in throat swabs. RNA was detected in 54 % of those who reported symptoms compatible with COVID-19, but in only 4% who were asymptomatic. Conclusion: This capability was established rapidly and utilised a cold-chain free methodology, applicable to a wide range of settings, and which can provide surge capacity and support to clinical laboratories facing increasing pressure during periods of national crisis.

Original languageEnglish
Article number104469
JournalJournal of Clinical Virology
Volume128
DOIs
Publication statusPublished - Jul 2020

Bibliographical note

Funding Information:
Support for this work was provided by University Hospitals Birmingham NHS Foundation Trust, Public Health England and the University of Birmingham. The Pathology directorate of the Queen Elizabeth Hospital provided specimens and support for sample collection. Occupational Health staff at the UHB NHS Foundation Trust co-ordinated reporting of specimen results and arranged for sample collection in community settings from HCW. The data produced from this work was reported back to the trust for action in line with Occupational Health and Infection Prevention and Control measures. Technical support was kindly provided by CerTest, the manufacturers of the VIASURE qRT-PCR kit. High Containment Work was kindly supported by students and staff working for Dr Matt O’Shea of the UHB NHS Foundation Trust and University of Birmingham. Establishment of this workflow would not have been possible without support from the Clinical Virologists from the regional Public Health England laboratory at Heartlands Hospital.

Funding Information:
The work described in this manuscript was funded by National Health Service Improvement (NHSI) with contributions directly from the University Hospitals Birmingham NHS Foundation Trust, core funding from the University of Birmingham, and staff from Public Health England participated in the establishment of the service. ADB is currently supported by a Cancer Research UK Advanced Clinician Scientist award (C31641/A23923) and his laboratory is supported by a Cancer Research UK Centre Award and Experimental Cancer Medicine Centre Award (C11497/A25127).

Publisher Copyright:
© 2020 The Author(s)

Keywords

  • Birmingham
  • COVID-19
  • Coronavirus
  • Rapid response
  • SARS-CoV-2
  • VIASURE qRT-PCR
  • West Midlands

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