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.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: HEPATITIS C (HCV)
• Intervention / Treatment: Diagnostic test: Panbio™ HCV Self Test

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.

• Study Type: Interventional
• Enrollment (Estimated): 1185
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla S Forssten, PhD; Phone Number: +447792902244; Email: camilla.forssten@abbott.com
• Study Contact Backup: Name: Jocelyn Farge, MSc, MBA; Phone Number: +33666483563; Email: jocelyn.farge@abbott.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability evaluation - lay user experience	To assess the usability of the Panbio™ HCV Self Test, as performed by lay users, based on a participant questionnaire evaluation by the lay user participant. The participant questionnaire includes questions to assess the lay users' experience when performing the test. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer.	5 months
Lay user / professional user results interpretation concordance	To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer.	5 months
Usability evaluation - Self-test observer records	To assess the usability of the Panbio™ HCV Self Test, as performed by lay users based on a questionnaire evaluation by the study staff observer. In the observer questionnaire, particular attention will be paid to compliance regarding factors considered critical for the test, such as reading the IFU/ QRG and applying the correct test volume. The observer questionnaire is not reporting scores on a scale, but is recording observations regarding how the users complete each step. For each step, a question is asked whether the user conducted a certain procedure, and a Yes / No answer is requested, with Monitor Notes when applicable.	5 months

Collaborators and Investigators

• Sponsor: Abbott Rapid Dx
• Collaborators: Aga Khan University; Clinic 553 Karachi; Ezintsha Clinical Research Center
• Investigators: Principal Investigator: Huma Qureshi, MD, Clinic 553; Principal Investigator: Saeed Hamid, Pr, Aga Khan University; Principal Investigator: Mohammed Majam, BSc, MBA, Ezintsha

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: hepatitis C; diagnostics; rapid test; untrained user; lateral flow test
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: SDRD-I-030-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No