NCT06605573

Lay User Evaluation of the Panbio™ HCV Self-Test

Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,185 (estimated)
• Sponsor: Abbott Rapid Dx · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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).

Detailed description

Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.

Conditions

• HEPATITIS C (HCV)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Panbio™ HCV Self Test	Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-09-20
• Last updated: 2024-09-20