Lay User Evaluation of the Panbio™ HCV Self-Test

NCT06605573 | Not Yet Recruiting

• 1 other identifier: SDRD-I-030-P
• Study Type: interventional
• Target: 1,185
• Locations: 0 countries
• Sites: N/A

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 Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).

Conditions

HEPATITIS C (HCV)

Keywords

diagnostics; rapid test; untrained user; hepatitis C; lateral flow test

Outcome Measures

Primary Outcomes (2)

• Lay user / professional user test result concordance

  To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test.

  5 months

• Lay user / laboratory test result concordance

  To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples.

  5 months

Secondary Outcomes (3)

• Usability evaluation - lay user experience

  5 months

• Usability evaluation - Self-test observer records

  5 months

• Lay user / professional user results interpretation concordance

  5 months

Interventions

Panbio™ HCV Self Test DIAGNOSTIC_TEST

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

Also known as: Fingerstick HIV testing (optional), Laboratory reference testing for HCV (immunoassays and PCR, CE marked)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is aged 14 or over
• Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.

You may not qualify if:

• Participant has already participated in this study on a previous occasion.
• Participant is aware of their HCV status
• Participant is deemed unfit for the study by the Investigator.
• Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
• Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
• Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
• Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
• Participant is unwilling or unable to provide informed consent.
• Participant has participated in the study "Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation".

Sponsors & Collaborators

• Abbott Rapid Dx: lead
• Aga Khan University: collaborator
• Clinic 553 Karachi: collaborator
• Ezintsha Clinical Research Center: collaborator

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Huma Qureshi, MD

  Clinic 553

  PRINCIPAL INVESTIGATOR

• Saeed Hamid, Pr

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Mohammed Majam, BSc, MBA

  Ezintsha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyn Farge, MSc, MBA

CONTACT

+33666483563; jocelyn.farge@abbott.com

Camilla S Forssten, PhD

CONTACT

+447792902244; camilla.forssten@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study staff member who interprets the lay user\'s result will be blinded to the lay user\'s reference test results and medical status. The study staff member who conducts the Panbio™ HCV Self Test for the lay user will also be blinded to the lay user\'s reference test results and medical status as well as the self-test results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assessment

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share