A holistic approach in patient management and epidemic surveillance through convergence of diagnostic technologies, capacity building and stakeholder engagement (HoliCare)

撒哈拉以南非洲的贫困相关疾病研究面临着重大的技术和非技术挑战，阻碍了许多地区获得高质量的医疗保健。不仅是它们的性能，而且可负担性、可制造性、对低收入和中等收入国家（LMICs）的适用性以及部署（少数）可用诊断方法都是确保撒哈拉以南非洲高质量医疗保健的主要障碍。HoliCare项目旨在通过弥合技术卓越、可用基础设施、能力和当地对新技术的吸收之间的差距，从整体角度解决这些挑战。我们选择将下呼吸道感染作为我们新方法的蓝图，因为它们具有巨大的临床和社会经济影响，并且与SARS-CoV-2大流行有关。在技术方面，我们提出了一种两层、数字接口的诊断方法，该方法将在现场使用多路侧流测试进行快速筛选和分类，随后转诊到医院（必要时），并使用pocc仪器进行同步核酸扩增（LAMP）进行病原体鉴定和免疫测定进行宿主生物标志物定量进行详细诊断。数字和制造基础设施将包括这些技术创新，以确保未来的本地产品开发。将开发质量控制的生物库，以进行可靠的临床研究。培训和人力资本投资将通过重点突出的高级别培训活动来实现。采用和实施活动将为成功部署拟议的诊断解决办法铺平道路，符合当地人口的目的。我们的开发将具有可扩展性、适应性和可转移性，适用于其他疾病和国家（生态）系统，旨在为改善撒哈拉以南非洲的医疗保健服务做出贡献。

Research on Poverty-Related Diseases (PRDs) in sub-Saharan Africa suffers from major technological and non-technological challenges that prevent high quality healthcare to reach many areas. Not only their performance, but also the affordability, manufacturability, suitability for Low- and Middle-Income Countries (LMICs) and deployment of the (few) available diagnostics are main barriers to ensure good quality of healthcare in sub-Saharan Africa. The HoliCare project aims to tackle such challenges from a holistic perspective, by bridging the gap between technological excellence, available infrastructures, capacity, and local uptake of new technologies. We have chosen to work with lower respiratory infections as a blueprint for our new approach due to their huge clinical and socioeconomic impact, and relevance to the SARS-CoV-2 pandemic. Technology-wise, we propose a 2-tiered, digitally interfaced diagnostic approach that will start in the field using multiplexed lateral flow tests for rapid screening and triage, followed by a referral to a hospital (when needed) and a follow-up detailed diagnosis using a POC-Instrument performing simultaneous nucleic acid amplification (LAMP) for pathogen identification and immunoassays for host biomarker quantitation. Digital and manufacturing infrastructures will encompass these technology innovations to ensure future local product development. Quality controlled biobanks will be developed for executing reliable clinical studies. Training and human capital investment will be achieved by focussed and high-level training activities. Adoption and implementation activities will pave the way for the proposed diagnostic solutions to be successfully deployed, fitting the purpose of the local populations. Our developments will be scalable, adaptable and transferrable to other diseases and national (eco) systems, aiming to contribute to the improvement of healthcare delivery in sub-Saharan Africa.