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

Sponsor
Abbott Rapid Dx
Study ID
NCT06492018
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Panbio™ HCV Self Test — DIAGNOSTIC_TEST
    Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Mar 30, 2025
Completion
Mar 30, 2025

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Lay user / professional user test result concordance [ Time Frame: 5 months ]

Central Contacts

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