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

Research output: Contribution to journalArticlepeer-review

Authors

  • Andrew Bosworth
  • Charlie Poxon
  • Kasun Wanigasooriya
  • Erin L Aldera
  • Danai Papakonstantinou
  • Gabriella L Morley
  • Eloise M Walker
  • Dee McLoughlin
  • Craig Webster
  • Tim Plant
  • Andrew Ellis
  • I Michael Kidd

External organisations

  • University Hospitals Birmingham NHS Foundation Trust
  • MRC Health Data Research UK (HDR UK), London, UK.

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.

Details

Original languageEnglish
Article number104469
JournalJournal of Clinical Virology
Volume128
Early online date23 May 2020
Publication statusPublished - Jul 2020

Keywords

  • Betacoronavirus/genetics, Clinical Laboratory Techniques/methods, Coronavirus Infections/diagnosis, Humans, Pandemics, Pneumonia, Viral/diagnosis, RNA, Viral/blood, Saliva/virology, Surge Capacity, United Kingdom, Workflow