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Lay User Evaluation of the Panbio™ HCV Self-Test

NCT06605573 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1185

Last updated 2024-09-20

No results posted yet for this study

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).

Conditions

  • HEPATITIS C (HCV)

Interventions

DIAGNOSTIC_TEST

Panbio™ HCV Self Test

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

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Clinic 553 Karachi

    collaborator UNKNOWN

  • Ezintsha Clinical Research Center

    collaborator UNKNOWN

  • Abbott Rapid Dx

    lead INDUSTRY

Principal Investigators

  • Huma Qureshi, MD · Clinic 553

  • Saeed Hamid, Pr · Aga Khan University

  • Mohammed Majam, BSc, MBA · Ezintsha

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-03-31
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06605573 on ClinicalTrials.gov