Lay User Evaluation of the Panbio™ HCV Self-Test

Abbott

Status

Not yet enrolling

Conditions

HEPATITIS C (HCV)

Treatments

Diagnostic Test: Panbio™ HCV Self Test

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06605573

SDRD-I-030-P

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,185 estimated patients

Sex

All

Ages

14+ years old

Volunteers

Accepts Healthy Volunteers

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".