Assessing User Experience with the Bioline™ HCV Point-of-care Test in Primary Healthcare Settings in Ghana: A Mixed-Methods Study
1
School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa
2
Department of Public Health, Klintaps University College of Health and Allied Sciences, Accra, Ghana
3
Department of Medical Laboratory Science, College of Health and Allied Sciences, University of Cape Coast, Ghana, Cape Coast, Ghana
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
ABSTRACT:
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. As part of a diagnostic trial in Ghana registered in the Pan African Clinical Trial Registry (PACTR202410837698664), 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. 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 test 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 that may compromise test validity under high temperatures exacerbated by climate change in the study setting. 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 contribute to Global Health by supporting SDG 3, enhancing access to timely HCV diagnosis, advancing progress toward Universal Health Coverage, and strengthening health systems in underserved areas, particularly in sub-Saharan Africa.
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. As part of a diagnostic trial in Ghana registered in the Pan African Clinical Trial Registry (PACTR202410837698664), 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. 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 test 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 that may compromise test validity under high temperatures exacerbated by climate change in the study setting. 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 contribute to Global Health by supporting SDG 3, enhancing access to timely HCV diagnosis, advancing progress toward Universal Health Coverage, and strengthening health systems in underserved areas, particularly in sub-Saharan Africa.
| eISSN: | 2654-1459 |
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