Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population

Launched by ABBOTT RAPID DX · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new self-test device called the Panbio™ HCV Self Test, which helps people check if they have Hepatitis C, a virus that can affect the liver. The study will evaluate how well people can use this test on their own, specifically using a small sample of blood from a fingerstick. The goal is to ensure that the test is safe and effective for everyday use by people without medical training.

To participate in this trial, you need to be at least 18 years old and willing to provide your consent to join the study. However, if you have any serious health issues that might make it unsafe to perform the test, or if you have prior medical training, you wouldn’t be eligible. Participants will be guided on how to use the test, and the study aims to gather helpful information to support the test's approval for public use. This is an exciting opportunity to contribute to the understanding of Hepatitis C testing!

Gender

ALL

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.