Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Dami A Collier; Sonny M Assennato; Ben Warne; Nyarie Sithole; Katherine Sharrocks; Allyson Ritchie; Pooja Ravji; Matthew Routledge; Dominic Sparkes; Jordan Skittrall; Anna Smielewska; Isobel Ramsey; Neha Goel; Martin Curran; David Enoch; Rhys Tassell; Michelle Lineham; Devan Vaghela; Clare Leong; Hoi Ping Mok; John Bradley; Kenneth G C Smith; Vivienne Mendoza; Nikos Demiris; Martin Besser; Gordon Dougan; Paul J Lehner; Mark J Siedner; Hongyi Zhang; Claire S Waddington; Helen Lee; Ravindra K Gupta; CITIID-NIHR COVID BioResource Collaboration

doi:10.1016/j.xcrm.2020.100062

Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Cell Rep Med. 2020 Aug 25;1(5):100062. doi: 10.1016/j.xcrm.2020.100062. Epub 2020 Jul 15.

Authors

Dami A Collier^{1

2}, Sonny M Assennato³, Ben Warne^{2

4

5}, Nyarie Sithole⁴, Katherine Sharrocks⁴, Allyson Ritchie³, Pooja Ravji⁴, Matthew Routledge⁴, Dominic Sparkes⁴, Jordan Skittrall⁴, Anna Smielewska⁴, Isobel Ramsey⁴, Neha Goel³, Martin Curran⁶, David Enoch⁶, Rhys Tassell⁷, Michelle Lineham⁷, Devan Vaghela⁴, Clare Leong⁴, Hoi Ping Mok⁴, John Bradley^{5

8}, Kenneth G C Smith^{2

5}, Vivienne Mendoza⁹, Nikos Demiris¹⁰, Martin Besser¹¹, Gordon Dougan^{2

5}, Paul J Lehner^{2

5}, Mark J Siedner^{12

13}, Hongyi Zhang⁶, Claire S Waddington^{4

5}, Helen Lee³, Ravindra K Gupta^{2

4

5

14}; CITIID-NIHR COVID BioResource Collaboration

Collaborators

CITIID-NIHR COVID BioResource Collaboration:
Stephen Baker, John Bradley, Gordon Dougan, Ian Goodfellow, Ravindra K Gupta, Paul J Lehner, Paul Lyons, Nicholas J Matheson, Kenneth Gc Smith, Mark Toshner, Michael P Weekes, Nick Brown, Martin Curran, Surendra Palmar, Hongyi Zhang, David Enoch, Daniel Chapman, Ashley Shaw, Vivien Mendoza, Sherly Jose, Areti Bermperi, Julie Ann Zerrudo, Evgenia Kourampa, Caroline Saunders, Ranalie de Jesus, Jason Domingo, Ciro Pasquale, Bensi Vergese, Phoebe Vargas, Marivic Fabiculana, Marlyn Perales, Richard Skells, Lee Mynott, Elizabeth Blake, Amy Bates, Anne-Laure Vallier, Alexandra Williams, David Phillips, Edmund Chiu, Alex Overhill, Nicola Ramenante, Jamal Sipple, Steven Frost, Helena Knock, Richard Hardy, Emily Foster, Fiona Davidson, Viona Rundell, Purity Bundi, Richmond Abeseabe, Sarah Clark, Isabel Vicente

Affiliations

¹ Division of Infection and Immunity, University College London, London WC1E 6BT, UK.
² Cambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UK.
³ Diagnostics for the Real World EU, Chesterford Research Park, Saffron Walden CB10 1XL, UK.
⁴ Department of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UK.
⁵ Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UK.
⁶ Clinical Microbiology & Public Health Laboratory, Public Health England, Cambridge CB2 0QQ, UK.
⁷ POC Testing, Department of Pathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, UK.
⁸ National Institutes for Health Research (NIHR) Cambridge Biomedical Research Centre, Cambridge CB2 0QQ, UK.
⁹ NIHR Cambridge Clinical Research Facility, Cambridge CB2 0QQ, UK.
¹⁰ Department of Statistics, Athens University of Economics and Business, 28is Oktovriou 76, 104 34 Athens, Greece.
¹¹ Department of Haematology, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, UK.
¹² Massachusetts General Hospital, Boston, MA, USA.
¹³ Harvard Medical School, Boston, MA, USA.
¹⁴ Africa Health Research Institute, Durban 4001, South Africa.

Abstract

There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR testing. Median time to result is 2.6 (IQR 2.3-4.8) versus 26.4 h (IQR 21.4-31.4, p < 0.001), with 32 (21.5%) positive and 117 (78.5%) negative. Cohen's κ correlation between tests is 0.96 (95% CI 0.91-1.00). When comparing nearly 1,000 tests pre- and post-implementation, the median time to definitive bed placement from admission is 23.4 (8.6-41.9) versus 17.1 h (9.0-28.8), p = 0.02. Mean length of stay on COVID-19 "holding" wards is 58.5 versus 29.9 h (p < 0.001). POC testing increases isolation room availability, avoids bed closures, allows discharge to care homes, and expedites access to hospital procedures. POC testing could mitigate the impact of COVID-19 on hospital systems.

Keywords: COVID-19; POC; SARS-CoV-2; diagnostic test; infection control; nosocomial; point of care.

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Adult
Aged
COVID-19 / diagnosis*
COVID-19 Nucleic Acid Testing* / standards
Cross Infection / prevention & control
Female
Hospitalization
Humans
Infection Control / methods*
Male
Middle Aged
Point-of-Care Testing* / standards
SARS-CoV-2 / genetics
SARS-CoV-2 / isolation & purification*

Abstract

Publication types

MeSH terms

Grants and funding