Lay User Evaluation of the Panbio™ HCV Self-Test
ConditionHEPATITIS C (HCV)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorAbbott Rapid Dx
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Panbio™ HCV Self Test
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Abbott Rapid Dx
Lead sponsor
Aga Khan University
Collaborator
Clinic 553 Karachi
Collaborator
Ezintsha Clinical Research Center
Collaborator
Source ClinicalTrials.gov