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，使高质量的医疗保健无法覆盖许多地区。不仅是它们的性能，而且负担得起、可制造性、对低收入和中等收入国家(LMIC)的适用性以及(少数)可用诊断方法的部署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、可用的基础设施、能力和当地采用新技术之间的差距，从整体的角度应对这些挑战。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，而且与SARS-CoV-2大流行相关。在技术方面，我们提出了一种两层的数字接口诊断方法，该方法将从现场开始，使用多路横向血流测试进行快速筛查和分类，然后转诊到医院(当需要时)，并使用POC仪器进行后续详细诊断，执行同步核酸扩增(LAMP)用于病原体识别和免疫分析用于宿主生物标记物的定量。数字和制造基础设施将包含这些技术创新，以确保未来的本地产品开发。将开发质量受控生物库，以执行可靠的临床研究。培训和人力资本投资将通过有重点和高水平的培训活动来实现。采用和实施活动将为成功部署拟议的诊断解决方案铺平道路，符合当地人口的目的。我们的发展将可扩展、可适应并可转移到其他疾病和国家(ECO)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.