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

撒哈拉以南非洲地区的贫困相关疾病 (PRD) 研究面临着重大的技术和非技术挑战，导致许多地区无法获得高质量的医疗服务。不仅是它们的性能，而且负担能力、可制造性、中低收入国家 (LMIC) 的适用性以及（少数）可用诊断的部署都是确保撒哈拉以南非洲地区良好医疗质量的主要障碍。 HoliCare 项目旨在通过缩小技术卓越、可用基础设施、能力和当地新技术采用之间的差距，从整体角度应对这些挑战。我们选择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 大流行相关。在技​​术方面，我们提出了一种两层数字接口诊断方法，该方法将在现场开始使用多重侧向层析测试进行快速筛查和分类，然后转诊至医院（需要时），并使用 POC 仪器进行后续详细诊断，该 POC 仪器执行同步核酸扩增 (LAMP) 进行病原体识别和宿主生物标志物定量的免疫测定。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。将开发质量受控的生物库来执行可靠的临床研究。培训和人力资本投资将通过有针对性、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，满足当地居民的需求。我们的开发将具有可扩展性、适应性和可转移到其他疾病和国家（生态）系统的能力，旨在为改善撒哈拉以南非洲地区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.