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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Lay user / professional user test result concordance — 5 months
  To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test.
• Lay user / laboratory test result concordance — 5 months
  To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples.

Trial sites (1)

Other trials for the same condition