Assessing user experience with the Bioline™ HCV point-of-care test in primary healthcare settings: a mixed-methods study.

Abstract

Background: Hepatitis C Virus (HCV) is a major public health challenge, particularly in resource-limited settings with inadequate diagnostic services. The Bioline™ HCV Point-of-Care (POC) test provides a promising solution for improving diagnosis in Primary Healthcare (PHC) clinics without laboratory infrastructure. This study evaluated the test's usability, acceptability, and deliverability in Ghana using user-oriented REASSURED criteria.

Methods: A convergent parallel mixed-methods design was adopted. Quantitative data was collected through direct observation of Healthcare Workers (HCWs) using audit checklists and analyzed with Stata 16. The analysis included descriptive statistics, inter-rater concordance assessment, and the application of the System Usability Scale (SUS). Qualitative data, analyzed using Atlas.ti 24.2.0, explored user experiences, confidence, storage infrastructure, and suggestions for test design improvement through in-depth interviews.

Results: The quantitative audit included 81 non-laboratory HCWs, with 22 participating in in-depth interviews. The test scored 88.7 on the SUS (95% CI: 86.40-90.88), with 88% of HCWs rating it as easy or very easy to use. Most HCWs (81.5%) successfully completed all testing steps independently, achieving 100% inter-rater concordance, but 83% made errors in at least one step, primarily during pre-testing. Qualitative findings revealed widespread acceptance, confidence, and adaptability despite challenges with storage infrastructure.

Discussion: The Bioline™ HCV POC test demonstrated high usability and acceptance among HCWs in resource-limited settings. Enhancements such as improved packaging, simplified information sheets, refined droppers, and additional components like gloves could further optimize usability. These findings support the Sustainable Development Goal (SDG) 3 by enhancing access to timely HCV diagnosis, contributing to Universal Health Coverage, and strengthening health systems in underserved areas.

Trial registration: This study is part of a diagnostic trial registered in the Pan African Clinical Trial Registry ( https://pactr.samrc.ac.za ) on 24th October 2024 with trial registration number: PACTR202410837698664.