Combined RT-PCR and host response point-of-care testing in patients hospitalised with suspected COVID-19: a prospective diagnostic accuracy study

Accepted/In Press date: 20 April 2022

Published date: June 2022

Additional Information: Funding Information: Dr Tristan W Clark reports non-financial support from QIAGEN in the form of discounted equipment and consumables for this work. He also reports personal fees from BioMerieux and BioFire LLC, non-financial support from BioMerieux and BioFire LLC, personal fees from Synairgen Research Ltd, Roche, Cidara therapeutics, Janssen, Planet Innovation and Randox Diagnostics, and grants from NIHR, all outside this work. Dr Kate R Beard has received honoraria from Randox Laboratories Ltd, outside this work. Dr Nathan J Brendish, Dr Alex R Tanner, Dr Stephen Poole, Dr Vasanth V Naidu, Dr Christopher T Mansbridge, Dr Nicholas J Norton, Mrs Helen Wheeler, and Mrs Laura Presland have nothing to disclose. Funding Information: We acknowledge and thank to all the patients who kindly participated in this study and all the clinical staff at University Hospital Southampton NHS Foundation Trust who cared for them. This report is independent research supported by the National Institute for Health Research (NIHR Post Doctoral Fellowship, Dr Tristan Clark, PDF 2016-09-061). Dr Nathan Brendish is supported by a NIHR Clinical Lecturer post. 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. This study was funded by University Hospital Southampton NHS Foundation Trust and 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 was supported by QIAGEN in the form of discounted equipment and consumables. The senior author had full access to all data and the final responsibility to submit for publication. The Journal’s Rapid Service Fee was funded by the authors. Dr Tristan W Clark reviewed the medical literature, conceived of and designed the study, oversaw the conduct of the study, did the analysis and interpretation of results, and drafted the manuscript. Dr Nathan J Brendish assisted with the design of the study, screened and recruited patients, collected data and drafted the manuscript. Dr Alex R Tanner collected data and drafted the manuscript. Dr Stephen Poole screened and recruited patients, collected data, and curated data. Dr Kate R Beard, Dr Vasanth V Naidu, Dr Christopher T Mansbridge, Dr Nicholas J Norton, Mrs Helen Wheeler and Mrs Laura Presland screened and recruited patients and/or collected data. All authors reviewed and contributed to the manuscript during its development. Dr Tristan W Clark, Dr Stephen Poole, and Dr Nathan J Brendish have verified the underlying data. Dr Tristan W Clark reports non-financial support from QIAGEN in the form of discounted equipment and consumables for this work. He also reports personal fees from BioMerieux and BioFire LLC, non-financial support from BioMerieux and BioFire LLC, personal fees from Synairgen Research Ltd, Roche, Cidara therapeutics, Janssen, Planet Innovation and Randox Diagnostics, and grants from NIHR, all outside this work. Dr Kate R Beard has received honoraria from Randox Laboratories Ltd, outside this work. Dr Nathan J Brendish, Dr Alex R Tanner, Dr Stephen Poole, Dr Vasanth V Naidu, Dr Christopher T Mansbridge, Dr Nicholas J Norton, Mrs Helen Wheeler, and Mrs Laura Presland have nothing to disclose. The study was approved by the South Central—Hampshire A Research Ethics Committee: reference 20/SC/0138, on 16 March 2020. The study was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments. This study was prospectively registered with the ISRCTN (ISRCTN14966673) on 18 March 2020. Access to de-identified study participant data may be available on reasonable request to the senior author after this publication. Funding Information: We acknowledge and thank to all the patients who kindly participated in this study and all the clinical staff at University Hospital Southampton NHS Foundation Trust who cared for them. This report is independent research supported by the National Institute for Health Research (NIHR Post Doctoral Fellowship, Dr Tristan Clark, PDF 2016-09-061). Dr Nathan Brendish is supported by a NIHR Clinical Lecturer post. 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. Funding Information: This study was funded by University Hospital Southampton NHS Foundation Trust and 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 was supported by QIAGEN in the form of discounted equipment and consumables. The senior author had full access to all data and the final responsibility to submit for publication. The Journal’s Rapid Service Fee was funded by the authors. Publisher Copyright: © 2022, The Author(s).

Keywords: COVID-19, Composite clinical reference standard, Diagnostic accuracy, FebriDx, MxA, Point-of-care test, RT-PCR

Local EPrints ID: 457371

URI: http://eprints.soton.ac.uk/id/eprint/457371

DOI: doi:10.1007/s40121-022-00646-4

ISSN: 2193-6382

PURE UUID: f7aa5b72-146f-4754-976e-64593c0840df

ORCID for Nathan Brendish: orcid.org/0000-0002-9589-4937

ORCID for Tristan Clark: orcid.org/0000-0001-6026-5295

Date deposited: 06 Jun 2022 16:36

Last modified: 27 Apr 2024 02:10