Evaluation of a COVID-19 lateral flow self-test: What is the performance of the Panbio™ COVID-19 self-test device when performed by lay users?

Not Applicable

Completed

• Conditions: SARS-CoV-2 infection; Infections and Infestations

• Registration Number: ISRCTN38930336
• Lead Sponsor: Abbott Rapid Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-13
• Study Start: 2022-01-27
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 312

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified