Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Abbott Rapid Dx
- Trial code
- NCT06492018
- Record updated
- 22 November 2024
- Original description
This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.Read full original descriptionShow less
This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.
Inclusion: Participant is aged 18 or over; Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.
Exclusion: Participant has already participated in this study on a previous occasion; Participant is currently enrolled in a study to evaluate an investigational drug or vaccine; Participant has a condition deemed unfit by the Investigator to safely perform or receive the test; Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use; Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience; Participant is deemed unfit for the study by the Investigator; Participant is unwilling or unable to provide informed consent.