COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Current intervention as of 16/03/2022:
RAPid Community Testing fOR COVID-19 (RAPTOR-C19) incorporates a series of prospective observational diagnostic accuracy studies of COVID-19 point-of-care diagno
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| '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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/03/2022: 1. 'Standard' diagnostic accuracy of point-of-care tests for past COVID-19 infection with reference to the Public Health England reference standard, measured at baseline visit 2. 'Enhanced' diagnostic accuracy of POCTs for active COVID-19 infection assessed against a composite reference standard using multiple tests data, linked electronic health records data, and patient-reported outcomes data, measured at baseline visit, follow-up visit (day 28) and follow-up in EHR Previous secondary outcome measures: 1. 'Standard' diagnostic accuracy of point-of-care tests for past COVID-19 infection with reference to the Public Health England reference standard, measured at baseline visit 2. 'Enhanced' diagnostic accuracy of POCTs for active COVID-19 infection assessed against a composite reference standard using multiple tests data, linked electronic health records data, and patient-reported outcomes data, measured at baseline visit, follow-up visit (day 28) and follow-up in EHR 3. 'Enhanced' diagnostic accuracy of POCTs for past COVID-19 infection assessed against a composite reference standard using multiple tests data, linked electronic health records, and patient-reported outcomes data, measured at baseline visit, follow-up visit (day 28) and follow-up in EHR | — |
Countries
England, United Kingdom
Contacts
Public ContactMary Logan
Outcome results
None listed