Duah Evans, Mathebula Evans Mantiri, Maluleke Kuhlula, Baloyi Tinyiko Violet, Ephraim Richard Kobina Dadzie, Mashamba-Thompson Tivani
Faculty of Health Sciences, School of Health Systems and Public Health, University of Pretoria, Pretoria, 0002, South Africa.
Department of Medical Laboratory Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, PMB, Cape Coast, Ghana.
BMC Health Serv Res. 2025 Apr 1;25(1):484. doi: 10.1186/s12913-025-12634-8.
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.
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 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.
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.
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.
丙型肝炎病毒（HCV）是一项重大的公共卫生挑战，在诊断服务不足的资源有限环境中尤为如此。Bioline™ HCV即时检测（POC）为在没有实验室基础设施的初级医疗保健（PHC）诊所改善诊断提供了一个有前景的解决方案。本研究使用以用户为导向的REASSURED标准评估了该检测在加纳的可用性、可接受性和可交付性。
采用了收敛平行混合方法设计。通过使用审核清单直接观察医护人员（HCW）收集定量数据，并使用Stata 16进行分析。分析包括描述性统计、评分者间一致性评估以及系统可用性量表（SUS）的应用。使用Atlas.ti 24.2.0分析定性数据，通过深入访谈探索用户体验、信心、存储基础设施以及对检测设计改进的建议。
定量审核包括81名非实验室医护人员，其中22人参与了深入访谈。该检测在SUS上的得分为88.7（95%置信区间：86.40 - 90.88），88%的医护人员将其评为易于使用或非常易于使用。大多数医护人员（81.5%）独立成功完成了所有检测步骤，评分者间一致性达到100%，但83%的人至少在一个步骤中出现错误，主要是在检测前。定性研究结果显示，尽管存储基础设施存在挑战，但该检测仍获得了广泛的接受、信心和适应性。
Bioline™ HCV POC检测在资源有限环境中的医护人员中显示出高可用性和可接受性。改进包装、简化信息表、优化滴管以及增加手套等额外组件等改进措施可以进一步优化可用性。这些发现通过加强及时获得HCV诊断的机会，为实现全民健康覆盖以及加强服务不足地区的卫生系统做出贡献，从而支持可持续发展目标（SDG）3。
本研究是2024年10月24日在泛非临床试验注册中心（https://pactr.samrc.ac.za ）注册的一项诊断试验的一部分，试验注册号为：PACTR202410837698664。
