Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population

This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.

Study Overview

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

Detailed Description

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). 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, around 50 million people per year are living with HCV, resulting in 244,000 deaths. The WHO estimates that only 36% 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.

The Panbio™ HCV Self Test, is a lateral flow test, designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood. The test is designed to be used by lay users and uses a sample volume of 10 µL. The professional use version test (Bioline™ HCV Test) is commercially available and has previously been clinically validated by the manufacturer, demonstrating a sensitivity of 99.3-100% and a specificity of 98.1-100%.

Evaluation of the test performance when used by professional users has been conducted, and evaluation of lay user sensitivity and specificity based on lay user populations outside the EU is being conducted. This study will demonstrate the test performance and usability of the test when used in a European lay user population. The study will be conducted at one recruiting hospital in Spain.

• Study Type: Observational
• Enrollment (Estimated): 150
• 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

Study Locations

• Spain
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
    • Contact: Pablo Ryan, MD, PhD; Email: pablo.ryan@salud.madrid.org
    • Contact: Jorge Valencia, MD, PhD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Participants with any known or suspected anti-HCV status may be enrolled.

Description

Inclusion Criteria:

• Participant is aged 18 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 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.

Study Plan

How is the study designed?

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
Labelling comprehension evaluation	To evaluate user experience and lay user participants' understanding of the test through a questionnaire. The participant questionnaire includes questions which are intended to evaluate the lay user's understanding of the Quick Reference Guide / Instructions for Use. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer.	5 months
Results interpretation evaluation	To evaluate the lay users' understanding of static test results (mock devices).	5 months
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
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
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

Collaborators and Investigators

• Sponsor: Abbott Rapid Dx
• Investigators: Principal Investigator: Pablo Ryan, MD, PhD, Hospital Universitario Infanta Leonor

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rapid diagnostic test; Self-test; Antibodies to Hepatitis C Virus (HCV).; Lay user
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C
• Other Study ID Numbers: SDRD-J-011-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