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NOT YET RECRUITING
NCT06605573
NA

Lay User Evaluation of the Panbio™ HCV Self-Test

Sponsor: Abbott Rapid Dx

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

Panbio™ HCV Self Test

Rapid diagnostic test (self-test and professional) plus laboratory reference tests