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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Work Stream A | Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19. |
| |
| Work Stream B | Known COVID-positive and/or COVID-negative community testing |
| |
| Work Stream C | Undifferentiated community testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care test for SARS-CoV-2 | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| If the participant has an active SARS-CoV-2 infection during admission | This will be determined using the point-of-care test and the laboratory test results | Baseline |
| The participant has had a past SARS-CoV-2 infection | This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results | Day 90 |
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Work Stream A (in-hospital; Group 1 and Group 2):
Group 1 Inclusion Criteria:
We will include participants (patients or staff):
Group 2 Inclusion Criteria:
We will include participants:
Work Stream B (Group 3):
We will include participants:
That are 18 years or older
EITHER:
They have been identified as positive for SARS-CoV-2 PCR through testing at national laboratory infrastructure OR
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:
Exclusion Criteria for all Work Streams:
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Work Stream A: Patients who present or are referred to secondary/tertiary care settings due to possible SARS-CoV-2 infection
Work Stream B: Known COVID-positive and/or COVID-negative community testing
Work Stream C: Undifferentiated community testing
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| Name | Affiliation | Role |
|---|---|---|
| Richard Body | Manchester University NHS Foundation Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandwell General Hospital Birmingham NHS Trust | Birmingham | United Kingdom | ||||
| University Hospitals of Derby and Burton NHS FT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40122534 | Derived | Byrne RL, Aljayyoussi G, Kontogianni K, Clerkin K, McIntyre M, Wardale J, Williams CT, Body R, Adams ER, de Vos M, Escadafal C, Cubas Atienzar AI. Head-to-head comparison of anterior nares and nasopharyngeal swabs for SARS-CoV-2 antigen detection in a community drive-through test centre in the UK. BMJ Open Respir Res. 2025 Mar 22;12(1):e001747. doi: 10.1136/bmjresp-2023-001747. |
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Throat and nose swabs and/or saliva samples may be taken at multiple time points and stored for future testing.
Whole blood samples may be taken at multiple time points during the study. Samples will be processed and the serum stored.
Finger stick samples may also be taken and stored for future testing.
| 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 | M13 9WU | 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 |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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