lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Now published in The Lancet

Clinical Impact of Molecular Point-of-Care Testing for Suspected COVID-19 in Hospital: A Prospective, Interventional, Non-Randomised, Controlled Study (COV-19POC)

33 Pages Posted: 27 Aug 2020

See all articles by Tristan Clark

Tristan Clark

National Institute for Health Research (NIHR)

Nathan James Brendish

School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton

Stephen Poole

University of Southampton - School of Clinical and Experimental Sciences

Vasanth V. Naidu

University Hospital Southampton NHS Foundation Trust - Department of Infection

Christopher Mansbridge

University Hospital Southampton NHS Foundation Trust - Department of Infection

Nicholas Norton

University Hospital Southampton NHS Foundation Trust - Department of Infection

Helen Wheeler

University Hospital Southampton NHS Foundation Trust - Department of Infection

Laura Presland

University Hospital Southampton NHS Foundation Trust - NIHR Southampton Biomedical Research Centre

Stephen Kidd

Department of Microbiology, Hampshire Hospital NHS Foundation Trust, Basingstoke and North Hants Hospital

Nick Cortes

University of Amsterdam - Department of Medical Microbiology

Florina Borca

NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust

Hang Phan

NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust

Gavin Babbage

NIHR Southampton Clinical Research Facility,University Hospital Southampton NHS Foundation Trust

Benoit Visseaux

Universitè de Paris, Assistance Publique – Hôpitaux de Paris, Laboratoire de Virologie, Hôpital Bichat

Sean Ewings

University of Southampton - Southampton Clinical Trials Unit

More...

Abstract

Background: The management of the COVID-19 pandemic is hampered by the long delays associated with centralised laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission. Rapid, accurate tests are therefore urgently needed for the next wave.   

Methods: We performed a prospective, interventional, non-randomised, controlled study of molecular point-of-care testing (POCT) in adults presenting to hospital with suspected COVID-19. Intervention group patients were tested using the QIAstat-Dx Respiratory SARS-CoV-2 Panel at the point-of-care and control patients were tested using laboratory PCR. The primary outcome was time to results. Secondary outcomes included infection control and diagnostic accuracy measures.

Findings: 499 patients were tested by POCT and 555 control patients were tested using laboratory PCR. Median (IQR) time to results with POCT was 1.7 (1.6 to 1.9) hours versus 21.3 (16.0 to 27.9) hours in the control group (difference of 19.6 hours, 95%CI 19.0 to 20.3; p<0.0001). Median (IQR) time to arrival in definitive clinical area (i.e. COVID-19 positive or negative ward) was 8.0 (6.0 to 15.0) hours in the POCT group versus 28.8 (23.5 to 38.9) hours in the control group, difference of 20.8 hours (96%CI 18.4 to 21.2; p<0.0001). Sensitivity of the QIAstat-Dx SARS-CoV-2 assay was 99.4% (95%CI 96.9 to 100) compared to 88.1% (95%CI 82.4 to 92.5) with laboratory PCR.

Interpretation: POCT was associated with large reductions in time to results and improvements in infection control measures, and had high diagnostic accuracy.

Trial Registration: This study is registered ISRCTN:14966673 and has completed.

Funding: University Hospitals Southampton NHS Foundation Trust

Declaration of Interests: TWC has received speaker fees, honoraria, travel reimbursement, and equipment and consumables free of charge for the purposes of research outside of this submitted study, from BioFire diagnostics LLC and BioMerieux. TWC has received consultancy fees from Synairgen research Ltd, Randox laboratories Ltd and Cidara therapeutics. He a member of an advisory board for Roche and a member of two independent data monitoring committees for trials sponsored by Roche. He has acted as the UK chief investigator for an IMP study sponsored by Janssen. All other authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare: no support from any organisation for the submitted work no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.

Ethics Approval Statement: The study was approved by the South Central - Hampshire A Research Ethics Committee: REC reference 20/SC/0138, on the 16th March 2020.

Keywords: COVID-19, SARS-COV-2, Point-of-care testing, hospital, infection control, accuracy

Suggested Citation

Clark, Tristan and Brendish, Nathan James and Poole, Stephen and Naidu, Vasanth V. and Mansbridge, Christopher and Norton, Nicholas and Wheeler, Helen and Presland, Laura and Kidd, Stephen and Cortes, Nick and Borca, Florina and Phan, Hang and Babbage, Gavin and Visseaux, Benoit and Ewings, Sean, Clinical Impact of Molecular Point-of-Care Testing for Suspected COVID-19 in Hospital: A Prospective, Interventional, Non-Randomised, Controlled Study (COV-19POC). Respiratory Medicine, October 8, 2020, https://doi.org/10.1016/S2213-2600(20)30454-9, Available at SSRN: https://ssrn.com/abstract=3666239 or http://dx.doi.org/10.2139/ssrn.3666239

Tristan Clark (Contact Author)

National Institute for Health Research (NIHR) ( email )

London, Oxfordshire
United Kingdom

Nathan James Brendish

School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton ( email )

Stephen Poole

University of Southampton - School of Clinical and Experimental Sciences ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Vasanth V. Naidu

University Hospital Southampton NHS Foundation Trust - Department of Infection ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Christopher Mansbridge

University Hospital Southampton NHS Foundation Trust - Department of Infection

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Nicholas Norton

University Hospital Southampton NHS Foundation Trust - Department of Infection

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Helen Wheeler

University Hospital Southampton NHS Foundation Trust - Department of Infection

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Laura Presland

University Hospital Southampton NHS Foundation Trust - NIHR Southampton Biomedical Research Centre

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Stephen Kidd

Department of Microbiology, Hampshire Hospital NHS Foundation Trust, Basingstoke and North Hants Hospital

Nick Cortes

University of Amsterdam - Department of Medical Microbiology

Amsterdam, 1105
Netherlands

Florina Borca

NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust ( email )

Hang Phan

NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust

Gavin Babbage

NIHR Southampton Clinical Research Facility,University Hospital Southampton NHS Foundation Trust ( email )

Benoit Visseaux

Universitè de Paris, Assistance Publique – Hôpitaux de Paris, Laboratoire de Virologie, Hôpital Bichat ( email )

Sean Ewings

University of Southampton - Southampton Clinical Trials Unit

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Click here to go to TheLancet.com

Paper statistics

Abstract Views
700
Downloads
72
PlumX Metrics