HEPATITIS C (HCV)
Conditions
Keywords
diagnostics, rapid test, untrained user, hepatitis C, lateral flow test
Brief summary
This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).
Detailed description
Hepatitis C is a liver disease caused by the hepatitis C virus. 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, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% 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.
Interventions
DIAGNOSTIC_TESTPanbio™ HCV Self Test
Rapid diagnostic test (self-test and professional) plus laboratory reference tests
Sponsors
Aga Khan University
Clinic 553 Karachi
Ezintsha Clinical Research Center
Abbott Rapid Dx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The study staff member who interprets the lay user's result will be blinded to the lay user's reference test results and medical status. The study staff member who conducts the Panbio™ HCV Self Test for the lay user will also be blinded to the lay user's reference test results and medical status as well as the self-test results.
Intervention model description
Single group assessment
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant is aged 14 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 aware of their HCV status * 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. * Participant has participated in the study Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lay user / professional user test result concordance | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability evaluation - lay user experience | 5 months | 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. |
| Usability evaluation - Self-test observer records | 5 months | 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. |
| Lay user / professional user results interpretation concordance | 5 months | To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer. |
Contacts
Primary ContactJocelyn Farge, MSc, MBA
Backup ContactCamilla S Forssten, PhD
Outcome results
None listed