Clinical Evaluation of the Panbio™ COVID-19 antigen self-test device as an over-the-counter (OTC) self-test

Abbott Rapid Diagnostics0 个研究点目标入组 312 人开始时间: 2022年1月27日最近更新: 2022年2月21日

试验速览

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•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

•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.

发起方

Abbott Rapid Diagnostics