COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
The study design involves the recruitment of a volunteer cohort (Phase I). which will involve three populations:
1. Individuals at higher risk of past coronavirus infection (healthcare workers) and l
Sponsors
Public Health England
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Currently working on-site at their place of work 2. Aged =18 years 3. Able to read English 4. Has an in-use personal email address and mobile phone
Exclusion criteria
Exclusion criteria: 1. Is currently experiencing COVID-19 compatible symptoms 2. Has experienced COVID-19 compatible symptoms in the last seven days 3. Meets the definition of “exceptionally vulnerable” on medical grounds, including immunosuppression, previous oncological treatments – these people should not be at work anyway 4. Unable to read normal-sized print with glasses 5. Taking part in vaccine studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, positive and negative predictive values of home testing kits (HTKs) for previous SARS-CoV-2 infection measured through patient-reported results when using HTKs observed by research staff compared to results from a "gold standard” reference test (laboratory immunoassay) of venous samples between baseline and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Test accuracy of HTKs when read by a trained professional in detecting anti-SARS-CoV-2 antibody, and in detecting previous SARS-CoV-2 infection. Sensitivity, specificity, PPV and NPV will be calculated based on readings by a trained professional in a clinical setting between baseline and 1 year 2. Agreement between untrained users and trained professionals in the reading of HTKs assessed by the proportion of agreement between the reading of the HTK results by: users of the service; trained professional examining a photograph; and a trained professional in a community setting between baseline and 1 year 3. Feasibility of home photographic recording of HTK and whether this enhances accuracy of recording relative to user reading by comparing the results (binary) from trained professionals "in vivo" to trained professionals when reading the picture between baseline and 1 year 4. Acceptability and usability of the HTKs in the population using semi-quantitative interviews in a clinic type setting between baseline and 1 year 5. Acceptability of the instructions and other advice to be provided to people undertaking the tests and to those who have a positive and a negative result following participant interviews and questionnaires undertaken in a clinic setting between baseline and 1 year | — |
Countries
England, United Kingdom
Outcome results
None listed