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

NCT06492018 | Not Yet Recruiting

• 1 other identifier: SDRD-J-011-P
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Keywords

Rapid diagnostic test; Antibodies to Hepatitis C Virus (HCV).; Self-test; Lay user

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 (5)

• Labelling comprehension evaluation

  5 months

• Results interpretation evaluation

  5 months

• 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: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (1)

Hospital Universitario infanta Leonor

Madrid, 28031, Spain

Location

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

• Pablo Ryan, MD, PhD

  Hospital Universitario Infanta Leonor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla S Forssten, PhD

CONTACT

+447792902244; camilla.forssten@abbott.com

Jocelyn Farge, MSc, MBA

CONTACT

+33666483563; jocelyn.farge@abbott.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 9, 2024
• Study Start: December 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)