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Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
Sponsor: Abbott Rapid Dx
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 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2024-12-01
Completion Date
2025-03-30
Last Updated
2024-11-22
Healthy Volunteers
Yes
Conditions
Interventions
Panbio™ HCV Self Test
Rapid diagnostic test (self-test and professional) plus laboratory reference tests
Locations (1)
Hospital Universitario infanta Leonor
Madrid, Spain