Clinical trial NCT06492018: Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
Official title: Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatitis C
Keywords: Rapid diagnostic test
Antibodies to Hepatitis C Virus (HCV).
Self-test
Lay user
Lead sponsor: Abbott Rapid Dx
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with any known or suspected anti-HCV status may be enrolled.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lay user / professional user test result concordance
timeFrame: 5 months
measure: Lay user / laboratory test result concordance
timeFrame: 5 months
Secondary outcomes:
measure: Labelling comprehension evaluation
timeFrame: 5 months
measure: Results interpretation evaluation
timeFrame: 5 months
measure: Usability evaluation - lay user experience
timeFrame: 5 months
measure: Usability evaluation - Self-test observer records
timeFrame: 5 months
measure: Lay user / professional user results interpretation concordance
timeFrame: 5 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario infanta Leonor
Study officials:
affiliation: Hospital Universitario Infanta Leonor
name: Pablo Ryan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: