SARS-CoV-2 infection Infections and Infestations
Conditions
Interventions
The study methodology was similar for every participant in the trial. Each participant (lay user) was provided with a Panbio™ COVID-19 Antigen Self-Test single-use test kit. The participant self-coll
Sponsors
Abbott Rapid Diagnostics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants =16 years old (UK) or =18 years old (Sweden and Spain); 2. Participant belongs to a general population (all-comers), in particular: 2.1 Participant has tested positive for COVID-19 by PCR with a sample obtained within the past 4-120 hours and is symptomatic within 0-7 days of onset, OR 2.2 Participant is symptomatic within 0-7 days of onset but has not been tested and has no specific known exposure, OR 2.3 Participant has tested positive for COVID-19 with a sample obtained within the past 4-48 hours and is asymptomatic for the last 14 days, OR 2.4 Participant is suspected, by study staff or by themselves, to have been exposed to COVID-19 within the last 10 days (period of self-isolation) and is symptomatic or asymptomatic
Exclusion criteria
Exclusion criteria: 1. If symptomatic, participant is =8 days post first symptom onset. 2. Participant has had a nasal or a nasopharyngeal swab taken within the last 4 hours. 3. Participant has prior medical or laboratory training. 4. Participant currently works within a laboratory and/or point of care environment in a non-administrative role. 5. Participant is a trained laboratory professional or health care professional. 6. Participant has active nose bleeds or acute facial injuries/trauma. 7. Participant is currently enrolled in a study to evaluate an investigational drug. 8. Participant has already participated in this study. 9. Participant is unable or unwilling to provide informed consent. 10. Participant belongs to a vulnerable population and is deemed inappropriate for study participation by site Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical performance (diagnostic sensitivity and specificity) of the Panbio™ COVID-19 Antigen Self-Test device, as performed by self-testers (lay users) using self-collected nasal samples. The lay user result will be compared with the Panbio™ COVID-19 Antigen Professional Use test (study reference result), as performed by health care professionals using nasopharyngeal samples, collected from the same subject at a single time point | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment, through lay user and study staff observer questionnaires, of the usability of the Panbio™ COVID-19 Antigen Self-Test, as performed by lay users with no laboratory or clinical experience at a single time point | — |
Countries
England, Spain, Sweden, United Kingdom
Outcome results
None listed