Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
ConditionHepatitis C
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Rapid Dx
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Participant has already participated in this study on a previous occasion.
Participant is deemed unfit for the study by the Investigator.
Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
Trial design
Treatments tested in this trial
- Panbio™ HCV Self Test
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov