Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
NCT Number: NCT06492018
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatitis C
Interventions: DIAGNOSTIC_TEST: Panbio™ HCV Self Test
Sponsor: Abbott Rapid Dx
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2024-12-30
Locations: Hospital Universitario infanta Leonor, Madrid, 28031, Spain

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.

Primary Outcome Measures: 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: 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