1. Rapid implementation and validation of a cold-chain free SARS-CoV-2 diagnostic testing workflow to support surge capacity
- Author
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Andrew Ellis, Alex G. Richter, Oliver J Pickles, Eloise M Walker, Gabriella L. Morley, Craig Webster, Kasun Wanigasooriya, Andrew D Beggs, Celina Whalley, Andrew Bosworth, Dee E McLoughlin, Danai Papakonstantinou, Charlie Poxon, Agnieszka E. Zielinska, Tim Plant, I. Michael Kidd, and Erin L. Aldera more...
- Subjects
0301 basic medicine ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Pneumonia, Viral ,030106 microbiology ,Article ,VIASURE qRT-PCR ,Workflow ,Betacoronavirus ,03 medical and health sciences ,COVID-19 Testing ,0302 clinical medicine ,West Midlands ,Virology ,Health care ,Pandemic ,Humans ,Medicine ,030212 general & internal medicine ,Cold chain ,Saliva ,Pandemics ,Surge Capacity ,Clinical Laboratory Techniques ,business.industry ,SARS-CoV-2 ,Diagnostic test ,COVID-19 ,Birmingham ,medicine.disease ,United Kingdom ,Coronavirus ,Infectious Diseases ,RNA, Viral ,Rapid Response ,Medical emergency ,Coronavirus Infections ,business - 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. more...
- Published
- 2020