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Rapid implementation and validation of a cold-chain free SARS-CoV-2 diagnostic testing workflow to support surge capacity.
Bosworth, Andrew; Whalley, Celina; Poxon, Charlie; Wanigasooriya, Kasun; Pickles, Oliver; Aldera, Erin L; Papakonstantinou, Danai; Morley, Gabriella L; Walker, Eloise M; Zielinska, Agnieszka E; McLoughlin, Dee; Webster, Craig; Plant, Tim; Ellis, Andrew; Richter, Alex; Kidd, I Michael; Beggs, Andrew D.
  • Bosworth A; Department of Laboratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Regional Public Health Laboratory, Public Health England, National Infection Service, Birmingham, UK.
  • Whalley C; Surgical Research Laboratory, Insitute of Cancer & Genomic Science, University of Birmingham, Birmingham, UK.
  • Poxon C; Regional Public Health Laboratory, Public Health England, National Infection Service, Birmingham, UK.
  • Wanigasooriya K; Surgical Research Laboratory, Insitute of Cancer & Genomic Science, University of Birmingham, Birmingham, UK.
  • Pickles O; Surgical Research Laboratory, Insitute of Cancer & Genomic Science, University of Birmingham, Birmingham, UK.
  • Aldera EL; High Containment Laboratories, University of Birmingham, Birmingham, UK.
  • Papakonstantinou D; High Containment Laboratories, University of Birmingham, Birmingham, UK.
  • Morley GL; High Containment Laboratories, University of Birmingham, Birmingham, UK.
  • Walker EM; High Containment Laboratories, University of Birmingham, Birmingham, UK.
  • Zielinska AE; High Containment Laboratories, University of Birmingham, Birmingham, UK.
  • McLoughlin D; High Containment Laboratories, University of Birmingham, Birmingham, UK.
  • Webster C; Department of Laboratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Plant T; Clinical Immunology Service, University of Birmingham, Birmingham, UK.
  • Ellis A; Clinical Immunology Service, University of Birmingham, Birmingham, UK.
  • Richter A; Clinical Immunology Service, University of Birmingham, Birmingham, UK.
  • Kidd IM; Department of Laboratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Regional Public Health Laboratory, Public Health England, National Infection Service, Birmingham, UK.
  • Beggs AD; Surgical Research Laboratory, Insitute of Cancer & Genomic Science, University of Birmingham, Birmingham, UK. Electronic address: A.Beggs@bham.ac.uk.
J Clin Virol ; 128: 104469, 2020 07.
Article in English | MEDLINE | ID: covidwho-343387
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / RNA, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus Type of study: Diagnostic study / Prognostic study / Qualitative research Limits: Humans Country/Region as subject: Europa Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104469

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / RNA, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus Type of study: Diagnostic study / Prognostic study / Qualitative research Limits: Humans Country/Region as subject: Europa Language: English Journal: J Clin Virol Journal subject: Virology Year: 2020 Document Type: Article Affiliation country: J.jcv.2020.104469