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Lay User Evaluation of the Panbio™ HCV Self-Test
Sponsor: Abbott Rapid Dx
Summary
This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).
Official title: Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1185
Start Date
2024-10
Completion Date
2025-03
Last Updated
2024-09-20
Healthy Volunteers
Yes
Conditions
Interventions
Panbio™ HCV Self Test
Rapid diagnostic test (self-test and professional) plus laboratory reference tests