Hepatitis CNCT06492018
Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
An observational study of Hepatitis C, run by Abbott Rapid Dx at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Panbio™ HCV Self Test
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with any known or suspected anti-HCV status may be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario infanta Leonor
Madrid, 28031
Pablo Ryan, MD, PhD, pablo.ryan@salud.madrid.org
Jorge Valencia, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Panbio™ HCV Self Test
- Keywords
- Rapid diagnostic test, Antibodies to Hepatitis C Virus (HCV)., Self-test, Lay user
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panbio™ HCV Self TestDiagnostic test
Also called Fingerstick HIV testing (optional), Laboratory reference testing for HCV (immunoassays and PCR, CE marked)
Rapid diagnostic test (self-test and professional) plus laboratory reference tests
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 months
Secondary outcomes (5)
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.
Measured: 5 months
Results interpretation evaluation
To evaluate the lay users' understanding of static test results (mock devices).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Ryan, MD, PhD, Principal investigator, Hospital Universitario Infanta Leonor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492018
- Sponsor's protocol ID
- SDRD-J-011-P
- Status last verified
- Nov 2024
- First submitted
- 16 May 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
- ClinicalTrials.gov ID
- NCT06492018
- Acronym / sponsor ID
- SDRD-J-011-P
- Conditions
- Hepatitis C
- Keywords
- Rapid diagnostic test, Antibodies to Hepatitis C Virus (HCV)., Self-test, Lay user
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with any known or suspected anti-HCV status may be enrolled.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panbio™ HCV Self TestAlso: Fingerstick HIV testing (optional), Laboratory reference testing for HCV (immunoassays and PCR, CE marked)Rapid diagnostic test (self-test and professional) plus laboratory reference tests | Diagnostic test | – |
Primary outcome
Lay user / professional user test result concordance
Time frame: 5 months
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.
Lay user / laboratory test result concordance
Time frame: 5 months
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 secondary outcomes
Labelling comprehension evaluation
Time frame: 5 months
Results interpretation evaluation
Time frame: 5 months
Usability evaluation - lay user experience
Time frame: 5 months
Usability evaluation - Self-test observer records
Time frame: 5 months
Lay user / professional user results interpretation concordance
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Ryan, MD, PhD principal investigator
Hospital Universitario Infanta Leonor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Abbott Rapid Dx at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla S Forssten, PhD (+447792902244, camilla.forssten@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lay user / professional user test result concordance (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.