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

Dami Collier ,Pooja Ravji,Evgenia Kourampa,Ranalie De Jesus,Paul J Lehner,Alexandra Williams,Stephen Baker,Alex Overhill,Isobel Ramsey,Devan Vaghela,Dominic Sparkes,Nick Brown,Vivienne Mendoza,Sarah Clark,David Phillips,Helena Knock,Anna Smielewska,Paul Lyons,Allyson Ritchie,Fiona Davidson,Sherly Jose,Hoi Ping Mok,Phoebe Vargas,Clare Leong,Matthew Routledge,Neha Goel,Daniel Chapman,Rhys Tassell,Ashley Shaw,Emily Foster,Vivien Mendoza,David Enoch,Anne-Laure Vallier,Ben Warne,Martin Besser,Hongyi Zhang,Purity Bundi,Viona Rundell,Ian Goodfellow,Michael P Weekes,Jamal Sipple,Ciro Pasquale,Richard Skells,Jason Domingo,Richmond Abeseabe,Julie Ann Zerrudo,Marivic Fabiculana,Areti Bermperi,Caroline Saunders,Surendra Palmar,Helen Lee,Claire S Waddington,Bensi Vergese,Isabel Vicente,Gordon Dougan,Nicola Ramenante,Katherine Sharrocks,Mark Toshner,Lee Mynott,Michelle Lineham,Marlyn Perales,Mark J Siedner,Nıkos Demiris ,Sonny Michael Assennato ,Elizabeth W Blake ,Richard W Hardy ,E K W Chiu ,Nicholas J Matheson ,Martin D Curran ,A Bates ,Nyaradzai Sithole ,Kenneth Smith ,Ravindra Gupta ,John R Bradley ,Steven A Frost ,Jordan P Skittrall

doi:10.1016/j.xcrm.2020.100062

Abstract

SummaryThere 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.

Highlights

As of June 22, 2020, 9.0 million people have been infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV2), with >469,939 deaths and 40,000 deaths in the United Kingdom attributed to coronavirus disease 2019 (COVID-19).[1]
The effective sensitivity of the SAMBA II SARS-CoV-2 test as compared to the standard lab reverse transcription polymerase chain reaction (RT-PCR) was 96.9%, with a specificity of 100% (Table 2)
We identified 561 tests in 388 individuals tested using the standard laboratory RT-PCR in the 10 days before SAMBA II SARS-CoV-2 introduction, and compared them with 913 tests done in 799 individuals using the point of care (POC) test in the 10 days post- SAMBA II SARS-CoV-2 introduction

Summary

Introduction

As of June 22, 2020, 9.0 million people have been infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV2), with >469,939 deaths and 40,000 deaths in the United Kingdom attributed to coronavirus disease 2019 (COVID-19).[1]. Due to the diverse presentations of COVID-19,7 lack of a timely diagnosis can have serious consequences, including deadly nosocomial outbreaks.[8]

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Conclusion