The United Kingdom and wider world is in the midst of the 2019 novel coronavirus (SARS-CoV-2) pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance to our response. Widespread population testing has proven difficult in western countries and has been limited by test availability, human resources and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients and early treatment for those most at risk. The life sciences industry has responded to the pandemic by developing multiple new in vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests we require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation in this global pandemic, we will conduct a platform adaptive diagnostic study on a national level, utilising a national network of expertise in the evaluation of diagnostic technology. This study will enable the evaluation of multiple assays in three priority areas: 1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2 2. Evaluation of assays monitoring the immune response to SARS-CoV-2 infection 3. Evaluation of the prognostic value of commercially available tests for predicting prognosis in patients with suspected or confirmed SARS-CoV-2 infection. (This arm will not be active immediately but may be activated after initiation).
Diagnostic Test: Point-of-care test for SARS-CoV-2
Throat and nose swabs and/or saliva samples and/or whole blood and/or finger stick samples may be taken to be tested on Point-of-care tests for SARS-CoV-2
Work Stream A (in-hospital; Group 1 and Group 2):
Group 1 Inclusion Criteria:
We will include participants (patients or staff):
1. That are 18 years or older
2. That will require testing for COVID-19 in the opinion of the treating clinician
3. That may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea,
anosmia) or chest x-ray changes or they may be asymptomatic but require testing for
other reasons
Group 2 Inclusion Criteria:
We will include participants:
1. That are 18 years or older
2. That have been admitted for another reason other than suspected SARS-CoV-2 infection,
but when routinely swabbed they have been identified as positive for SARS-CoV-2 PCR
Work Stream B (Group 3):
We will include participants:
1. That are 18 years or older
EITHER:
2. They have been identified as positive for SARS-CoV-2 PCR through testing at national
laboratory infrastructure OR
3. They have been identified as negative for SARS-CoV-2 PCR through testing at national
laboratory infrastructure
Work Stream C (Group 4):
We will include participants:
1. That are 18 years or older
2. Who are undergoing testing for COVID-19, whether they are symptomatic or symptomatic
for COVID-19
Exclusion Criteria for all Work Streams:
1. Patients where it is impossible/unsafe to obtain the required research samples
2. Prisoners
3. Patients where sampling is not feasible
Sandwell General Hospital Birmingham NHS Trust
Birmingham, United Kingdom
University Hospitals of Derby and Burton NHS FT
Derby, United Kingdom
Frimley Health NHS FT
Frimley, United Kingdom
Airedale NHS FT
Keighley, United Kingdom
Leeds Teaching Hospital NHS FT
Leeds, United Kingdom
St George's University Hospitals NHS FT
London, United Kingdom
Manchester University NHS FT
Manchester, United Kingdom
Newcastle upon Tyne Hospitals NHS FT
Newcastle Upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals NHS FT
Oxford, United Kingdom
Royal Berkshire Hospital NHS FT
Reading, United Kingdom
Barking, Havering & Redbridge Hospitals NHS FT
Romford, United Kingdom
Salford Royal NHS FT
Salford, United Kingdom
University Hospital Southampton NHS FT
Southampton, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
Richard Body, Study Director
Manchester University NHS Foundation Trust