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. Trial registration: ISRCTN14966673
Accuracy, COVID-19, Host response, MxA, Point of care testing, SARS-CoV-2
607-613
Clark, Tristan
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Brendish, Nathan
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Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
Naidu, Vasanth
df9bd215-344a-43b6-b568-60c783353fa9
Mansbridge, Christopher
a33c33a8-f813-46d2-92a0-ecde2233514a
Norton, Nicholas
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Wheeler, Helen
9ec21ee3-2e24-40c7-b342-64a2c371ef7a
Presland, Laura
f9595a32-b871-4d73-8444-dd0fffc08592
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
October 2020
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), .
(doi:10.1016/j.jinf.2020.06.051).
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. Trial registration: ISRCTN14966673
Text
FebriDX paper JoI 12-06-20 R1 clean
- Accepted Manuscript
More information
Accepted/In Press date: 20 June 2020
e-pub ahead of print date: 21 June 2020
Published date: October 2020
Additional Information:
Funding Information:
This study was funded by University Hospital Southampton Foundation NHS trust. The laboratory work, nursing costs and consumables were supported by the NIHR Southampton Biomedical Research Centre. Statistical analysis was supported by Cancer Research UK core funding and NIHR CTU support funding at the Southampton Clinical Trials Unit. The FebriDx kits were purchased independently from a UK distributer and the manufacturer (Lumos Diagnostics, Sarasota, Florida, USA) had no role in the study conception, design, data analysis or manuscript preparation. The parent study is supported by Qiagen in the form of discounted equipment and consumables. The corresponding author had full access to all of the data and the final responsibility to submit for publication.
Funding Information:
This report is independent research supported by the National Institute for Health Research (NIHR Post Doctorial Fellowship, Dr Tristan Clark, PDF 2016–09–061). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
Publisher Copyright:
© 2020 Elsevier Ltd
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
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Date deposited: 20 Jul 2020 16:30
Last modified: 21 Nov 2024 05:02
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Contributors
Author:
Stephen Poole
Author:
Vasanth Naidu
Author:
Christopher Mansbridge
Author:
Nicholas Norton
Author:
Helen Wheeler
Author:
Laura Presland
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