Lay User Evaluation of the Panbio™ HCV Self-Test

Lay user / professional user test result concordance

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

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.

Usability evaluation - lay user experience

To assess the usability of the Panbio™ HCV Self Test, as performed by lay users, based on a participant questionnaire evaluation by the lay user participant. The participant questionnaire includes questions to assess the lay users\' experience when performing the test. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer.

Usability evaluation - Self-test observer records

To assess the usability of the Panbio™ HCV Self Test, as performed by lay users based on a questionnaire evaluation by the study staff observer. In the observer questionnaire, particular attention will be paid to compliance regarding factors considered critical for the test, such as reading the IFU/ QRG and applying the correct test volume. The observer questionnaire is not reporting scores on a scale, but is recording observations regarding how the users complete each step. For each step, a question is asked whether the user conducted a certain procedure, and a Yes / No answer is requested, with Monitor Notes when applicable.

Lay user / professional user results interpretation concordance

To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer.