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 These preprints are early stage research papers that have not been peer-reviewed.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decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed.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.

Real-World Diagnostic Accuracy of a Host Response Point-of-Care Test in Hospitalised Patients with Suspected COVID-19

32 Pages Posted: 26 May 2020

See all articles by Nathan J. Brendish

Nathan J. Brendish

University of Southampton - School of Clinical and Experimental Sciences

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

Sean Ewings

University of Southampton - Southampton Clinical Trials Unit

Tristan Clark

National Institute for Health Research (NIHR)

More...

Abstract

Background: The management of the COVID-19 pandemic is hampered by long delays associated with centralised laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission and so rapid, accurate diagnostic tests are urgently required. The FebriDx is a CE-marked point-of-care test (POCT) that detects host response proteins in finger prick blood within 10 minutes to distinguish viral from bacterial respiratory infection, but its accuracy for the detection of COVID-19 is unknown.

Methods: We performed a real-world diagnostic accuracy study of the FebriDx in hospitalised patients, nested within a larger study assessing molecular diagnostics for COVID-19. Measures of diagnostic accuracy were calculated based on FebriDx results compared to the reference standard of PCR, and stratified based on duration of symptoms. A multivariable predictive model including FebriDx, age, sex, symptoms and signs was also developed and underwent internal validation. The parent study is registered, number ISRCTN17197293 and is ongoing.

Findings: 266 hospitalised adults with suspected COVID-19 were enrolled. FebriDx was performed on 251 patients and gave a valid result in 248. 118 of 248 (48%) were PCR positive for COVID-19. Sensitivity of FebriDx for the identification of COVID-19 was 93% (110/118; 95% CI 87 to 97%) and specificity was 86% (112/130; 95%CI 79 to 92%). Positive and negative likelihood ratios were 6.73 (95%CI 4.37 to 10.37) and 0.08 (95%CI 0.04 to 0.15) respectively. In the multivariate model diagnosis of COVID-19 was not significantly influenced by age or clinical symptoms and signs including fever, and FebriDx accuracy was not improved by restricting testing to those with duration of symptoms of less than seven days.

Interpretation: FebriDX has high diagnostic accuracy for the identification of COVID-19 in hospitalised adults and could be used as a front door triage tool, representing a cheap and widely available solution to delayed diagnosis.

Trial Registration: This study was prospectively registered with the ISRCTN14966673 on the 18th March 2020.

Funding Statement: This study was funded by University Hospital Southampton Foundation NHS trust.

Declaration of Interests: All other authors declare that they have no conflicts of interests relating to this 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; diagnosis; accuracy; point-of-care; host response; hospital

Suggested Citation

Brendish, Nathan J. and Poole, Stephen and Naidu, Vasanth V. and Mansbridge, Christopher and Norton, Nicholas and Wheeler, Helen and Presland, Laura and Ewings, Sean and Clark, Tristan, Real-World Diagnostic Accuracy of a Host Response Point-of-Care Test in Hospitalised Patients with Suspected COVID-19 (4/17/2020). Available at SSRN: https://ssrn.com/abstract=3582747 or http://dx.doi.org/10.2139/ssrn.3582747

Nathan J. Brendish

University of Southampton - School of Clinical and Experimental Sciences

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

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

Sean Ewings

University of Southampton - Southampton Clinical Trials Unit

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

Tristan Clark (Contact Author)

National Institute for Health Research (NIHR) ( email )

London, Oxfordshire
United Kingdom

Click here to go to TheLancet.com

Paper statistics

Abstract Views
947
Downloads
97
PlumX Metrics