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Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: A prospective, interventional, non-randomised pre and post implementation study (CoV-19POC) [Protocol]

Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: A prospective, interventional, non-randomised pre and post implementation study (CoV-19POC) [Protocol]
Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: A prospective, interventional, non-randomised pre and post implementation study (CoV-19POC) [Protocol]
Trial site
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK.

Trial locations
Emergency department (ED), Acute Medical Unit (AMU), Respiratory High Dependency Unit (RHDU), General Intensive Care Unit (GICU), medical wards and other locations, within University Hospital Southampton NHS Foundation Trust (UHS).

Aim
To evaluate the clinical impact and real-world diagnostic accuracy of routine molecular point-of-care testing for respiratory viruses including SARS-CoV-2 (the cause of COVID-19) in adults presenting to hospital with suspected COVID-19 and/or acute respiratory illness (ARI).

Design
Non-randomised, interventional, pre and post implementation study.

Population
Adults aged 18 years old and over presenting to hospital with suspected COVID-19 and/or ARI.

Sample Size
500 participants.

Intervention
Combined nose and throat swab (and lower respiratory tract samples where available) tested by QIAGEN QIAstat-Dx Respiratory 2019-nCoV Panel for SARS-CoV-2 and other respiratory viruses with results communicated to clinical and infection control teams in real time.

Control (pre-implementation)
Routine clinical care with testing for SARS-CoV-2 by laboratory RT-PCR performed in regional Public Health England (PHE) laboratory.

Key Assessment
Evaluation of clinical outcome measures, implementation feasibility, and real-world diagnostic accuracy.

Timing
12 months: April 2020 to April 2021 (with 6 months for patient recruitment) Plus a further five years after patient recruitment has ended for data and laboratory analysis of specimens.
University Hospital Southampton NHS Foundation Trust
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7

Clark, Tristan and Brendish, Nathan (2020) Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: A prospective, interventional, non-randomised pre and post implementation study (CoV-19POC) [Protocol] Southampton. University Hospital Southampton NHS Foundation Trust 38pp.

Record type: Monograph (Project Report)

Abstract

Trial site
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK.

Trial locations
Emergency department (ED), Acute Medical Unit (AMU), Respiratory High Dependency Unit (RHDU), General Intensive Care Unit (GICU), medical wards and other locations, within University Hospital Southampton NHS Foundation Trust (UHS).

Aim
To evaluate the clinical impact and real-world diagnostic accuracy of routine molecular point-of-care testing for respiratory viruses including SARS-CoV-2 (the cause of COVID-19) in adults presenting to hospital with suspected COVID-19 and/or acute respiratory illness (ARI).

Design
Non-randomised, interventional, pre and post implementation study.

Population
Adults aged 18 years old and over presenting to hospital with suspected COVID-19 and/or ARI.

Sample Size
500 participants.

Intervention
Combined nose and throat swab (and lower respiratory tract samples where available) tested by QIAGEN QIAstat-Dx Respiratory 2019-nCoV Panel for SARS-CoV-2 and other respiratory viruses with results communicated to clinical and infection control teams in real time.

Control (pre-implementation)
Routine clinical care with testing for SARS-CoV-2 by laboratory RT-PCR performed in regional Public Health England (PHE) laboratory.

Key Assessment
Evaluation of clinical outcome measures, implementation feasibility, and real-world diagnostic accuracy.

Timing
12 months: April 2020 to April 2021 (with 6 months for patient recruitment) Plus a further five years after patient recruitment has ended for data and laboratory analysis of specimens.

Text
CoV-19POC Protocol v1.1 - Other
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Text
CoV-19POC Protocol v2-0 eprints - Other
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More information

Published date: 12 March 2020
Additional Information: Internally peer-reviewed. Approved by Regional Ethics Committee and Health Research Authority. ISRCTN14966673

Identifiers

Local EPrints ID: 439309
URI: http://eprints.soton.ac.uk/id/eprint/439309
PURE UUID: be600f1d-cf31-4a80-b0a3-962f32eced20
ORCID for Tristan Clark: ORCID iD orcid.org/0000-0001-6026-5295
ORCID for Nathan Brendish: ORCID iD orcid.org/0000-0002-9589-4937

Catalogue record

Date deposited: 08 Apr 2020 16:32
Last modified: 07 Oct 2021 02:01

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