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The University of Southampton
Medicine

Research project: CERrnaTc-19 (Clinical Evaluation of Rapid RNA Test for Covid-19)

Currently Active: 
Yes

Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported.

The University of Oxford Institute of Biomedical Engineering has designed a new test which can produce results in 30 minutes. This uses a nose / throat swab like the current standard test. The swab is sent to the laboratory in a dry tube. In the laboratory, the swab is put into a vial of water, and a small amount of the water is put into a special test tube. This test tube contains a substance which can detect the presence of the novel Coronavirus (SARS-Cov2). The test tube is then simply warmed to 65’C for 30 minutes, and if the Coronavirus is present, the liquid will change colour from pink to yellow (positive). If there is no virus present in the sample, the colour remains pink (negative). This is designed to be a very simple test which does not need specialist skills or equipment, and so could be carried out in hospitals and even in primary care.

In this study we aim to evaluate the accuracy of this new test. We will take a second swab from 173 patients with suspected Covid-19 at Watford General hospital (who are being tested anyway) and will use these swabs to conduct the new test (in ideal laboratory conditions) as well as the standard test. As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient.

This study will enable us to discover rapidly whether the new test is accurate, and if so, we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.

Local Investigators:

Professor Michael Moore (Chief Investigator)

Dr Merlin Willcox, PPM, University of Southampton

Prof Paul Little, PPM, University of Southampton

Prof Nick Francis, PPM, University of Southampton

Prof Gareth Griffiths, Southampton CTU, University of Southampton

Assoc Prof Beth Stuart, Southampton CTU, University of Southampton

Collaborators:

Dr Hala Kandil, West Hertfordshire Hospitals NHS Trust

Prof Zhanfeng Cui, Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford

Prof Wei Huang, Department of Engineering Science, University of Oxford

Dr Chia-Chen Hsu, Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford

Dr Rama Vancheeswaran, West Hertfordshire Hospitals NHS Trust

Dr Matthew Knight, West Hertfordshire Hospitals NHS Trust

Dr Andrew Barlow, West Hertfordshire Hospitals NHS Trust

Dr Nida Suri, West Hertfordshire Hospitals NHS Trust

Dr Shajeel Khan, West Hertfordshire Hospitals NHS Trust

Dr Tristan Clark, University Hospital Southampton and University of Southampton

Professor Tom Wilkinson, University of Southampton

Study team:

Mrs Catherine Simpson, Senior Trial Manager, Southampton Clinical Trials Unit

Ms Wendy O’Brien, Study Manager, PPM, University of Southampton

Dr Clare McDermott, Study Manager, PPM, University of Southampton

Rachel Hilson, Microbiology biomedical scientist, West Hertfordshire Hospitals NHS Trust

Geraldine Yaze, Microbiology biomedical scientist, West Hertfordshire Hospitals NHS Trust

Sonal Parikh, Microbiology biomedical scientist, West Hertfordshire Hospitals NHS Trust

Suganshah Dilshan, Microbiology biomedical scientist, West Hertfordshire Hospitals NHS Trust

Funder:

This Study is not externally funded. The rapid RNA tests will be provided free of charge by the University of Oxford. The microbiology laboratory at Watford General Hospital will conduct these tests alongside the routine PCR tests and West Hertfordshire NHS Trust will cover the costs of laboratory technician time.  SCTU core funding (NIHR) will cover the involvement of the study manager and statistician.

Duration: 3 months    

End date 31 July 2020

Contact: M.L.Willcox@soton.ac.uk

Related research groups

Primary Care, Population Sciences and Medical Education
Primary Care Research Centre
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