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

NCT06492018 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-11-22

No results posted yet for this study

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. 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.

Conditions

  • Hepatitis C

Interventions

DIAGNOSTIC_TEST

Panbio™ HCV Self Test

Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Sponsors & Collaborators

  • Abbott Rapid Dx

    lead INDUSTRY

Principal Investigators

  • Pablo Ryan, MD, PhD · Hospital Universitario Infanta Leonor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492018 on ClinicalTrials.gov