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Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19

Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19
Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19
Introduction
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 point-of-care test that detects an antiviral host response protein in finger prick blood within 10 min, but its accuracy for the identification of COVID-19 is unknown.

Methods
We performed a real-world diagnostic accuracy study of FebriDx in hospitalised patients during the first wave of the pandemic. Measures of diagnostic accuracy were calculated based on FebriDx results compared to the reference standard of SARS-CoV-2 PCR on combined nose and throat swabs. A multivariable predictive model including FebriDx, age, sex, and clinical characteristics was developed and underwent internal validation.

Results
FebriDx was performed on 251 patients and gave a valid result in 248. 118 of 248 (48%) were PCR positive for COVID-19. FebriDx results were available after 10 min compared with 1.7 (1.6 to 2.1) hours with point-of-care PCR testing and 23.4 (17.2 to 31.1) hours with laboratory PCR testing. 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 age, sex and other clinical features did not contribute significantly to the effect of the FebriDx result in distinguishing patients with and without COVID-19.

Conclusions
During the first wave of the pandemic, FebriDx had high accuracy for the identification of COVID-19 in hospitalised adults and could be deployed as a front door triage tool.
Accuracy, COVID-19, Host response, MxA, Point of care testing, SARS-CoV-2
0163-4453
607-613
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Poole, Stephen
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Naidu, Vasanth
df9bd215-344a-43b6-b568-60c783353fa9
Mansbridge, Christopher
a33c33a8-f813-46d2-92a0-ecde2233514a
Norton, Nicholas
14bdade9-e59d-4b4a-a87f-ddb74d86d725
Wheeler, Helen
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Presland, Laura
f9595a32-b871-4d73-8444-dd0fffc08592
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
Naidu, Vasanth
df9bd215-344a-43b6-b568-60c783353fa9
Mansbridge, Christopher
a33c33a8-f813-46d2-92a0-ecde2233514a
Norton, Nicholas
14bdade9-e59d-4b4a-a87f-ddb74d86d725
Wheeler, Helen
9ec21ee3-2e24-40c7-b342-64a2c371ef7a
Presland, Laura
f9595a32-b871-4d73-8444-dd0fffc08592
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a

Clark, Tristan, Brendish, Nathan, Poole, Stephen, Naidu, Vasanth, Mansbridge, Christopher, Norton, Nicholas, Wheeler, Helen, Presland, Laura and Ewings, Sean (2020) Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19. Journal of Infection, 81 (4), 607-613. (doi:10.1016/j.jinf.2020.06.051).

Record type: Article

Abstract

Introduction
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 point-of-care test that detects an antiviral host response protein in finger prick blood within 10 min, but its accuracy for the identification of COVID-19 is unknown.

Methods
We performed a real-world diagnostic accuracy study of FebriDx in hospitalised patients during the first wave of the pandemic. Measures of diagnostic accuracy were calculated based on FebriDx results compared to the reference standard of SARS-CoV-2 PCR on combined nose and throat swabs. A multivariable predictive model including FebriDx, age, sex, and clinical characteristics was developed and underwent internal validation.

Results
FebriDx was performed on 251 patients and gave a valid result in 248. 118 of 248 (48%) were PCR positive for COVID-19. FebriDx results were available after 10 min compared with 1.7 (1.6 to 2.1) hours with point-of-care PCR testing and 23.4 (17.2 to 31.1) hours with laboratory PCR testing. 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 age, sex and other clinical features did not contribute significantly to the effect of the FebriDx result in distinguishing patients with and without COVID-19.

Conclusions
During the first wave of the pandemic, FebriDx had high accuracy for the identification of COVID-19 in hospitalised adults and could be deployed as a front door triage tool.

Text
FebriDX paper JoI 12-06-20 R1 clean - Accepted Manuscript
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More information

Accepted/In Press date: 20 June 2020
e-pub ahead of print date: 21 June 2020
Keywords: Accuracy, COVID-19, Host response, MxA, Point of care testing, SARS-CoV-2

Identifiers

Local EPrints ID: 442560
URI: http://eprints.soton.ac.uk/id/eprint/442560
ISSN: 0163-4453
PURE UUID: 1a799c6b-71ff-4e9f-81df-c5ab82090692
ORCID for Tristan Clark: ORCID iD orcid.org/0000-0001-6026-5295
ORCID for Nathan Brendish: ORCID iD orcid.org/0000-0002-9589-4937
ORCID for Sean Ewings: ORCID iD orcid.org/0000-0001-7214-4917

Catalogue record

Date deposited: 20 Jul 2020 16:30
Last modified: 07 Oct 2021 04:03

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