Status:
NOT_YET_RECRUITING
Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
Lead Sponsor:
Abbott Rapid Dx
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, life...
Eligibility Criteria
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 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
- Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
- 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 unwilling or unable to provide informed consent.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06492018
Start Date
December 1 2024
End Date
March 30 2025
Last Update
November 22 2024
Active Locations (1)
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1
Hospital Universitario infanta Leonor
Madrid, Spain, 28031