Rapid community testing for COVID-19

Not Applicable

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN14226970
• Lead Sponsor: niversity of Oxford

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33557927/ protocol (added 10/02/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37478103/ Roche-branded SD Biosensor Standard™ Q SARS-CoV-2 Rapid Antigen Test and/or BD Veritor™ System for Rapid Detection of SARS-CoV-2 (added 24/07/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38103638/ LumiraDx™ SARS-CoV-2 and influenza A or B assay (added 10/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Last Update Posted: 22 April 2024
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2262

Inclusion Criteria

1. Adults ( aged =16 years)
2. Males or females
3. With suspected current or past COVID-19 infection*
4. Having OP/NP swab for laboratory COVID-19 RT-PCR as part of clinical care/testing
5. Willing and able to give informed consent for participation in the study

1. Children ( aged <16 years)
2. Males or females
3. With suspected current COVID-19 infection*
4. Having OP/NP swab for laboratory COVID-19 RT-PCR as part of clinical care/testing
5. Parent or legal guardian is willing and able to give informed consent for participation in the study

* As the clinical features of COVID-19 are broad, especially in older or immunosuppressed individuals, restricting testing to a narrow spectrum of clinical features would lead to a limited in-context evaluation. The working definition of suspected current or past COVID-19 infection will be based on the current advice to consider COVID-19 infection in people who during the COVID-19 pandemic have:
1. Symptoms thought to be associated with COVID-19, including but not limited to: fever, cough, fatigue, dyspnoea, sputum production, shortness of breath, myalgia, chills, dizziness, headache, sore throat, hoarseness, nausea or vomiting, diarrhoea, nasal congestion
2. Acute respiratory distress syndrome
3. Either clinical or radiological evidence of pneumonia
4. Atypical presentations, for example an acute functional decline or frailty syndrome in an older person, if they are immunocompromised
5. Lived or worked in close contact with somebody who has tested positive for COVID-19, including NHS staff

Exclusion Criteria

1. Adults unable to understand the study information and give consent to take part in the study
2. Need for immediate hospitalisation
3. Previously enrolled in this study in relation to the individual test being evaluated

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
'Standard' diagnostic accuracy of point-of-care tests for active COVID-19 infection with reference to the Public Health England reference standard, measured at baseline visit