Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605573
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Lay User Evaluation of the Panbio HCV Self-Test
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lay User Evaluation of the Panbio HCV Self Test a Prospective Multi-centre Observed Untrained User Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Organisations technical guidance on Hepatitis C rapid diagnostic tests for professional use andor 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 700000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None