Coonahan Erin S, Amaratunga Chanaki, Long Carole A, Tarning Joel
Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, United States of America.
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
PLOS Glob Public Health. 2023 Aug 24;3(8):e0002087. doi: 10.1371/journal.pgph.0002087. eCollection 2023.
Point-of-care assays have greatly increased access to diagnostic information and improved healthcare outcomes globally, especially in the case of tropical diseases in rural settings. Increased recognition of the impact of these tools and increased funding, along with advances in technology have led to a surge in development of new assays. However, many new tools fail to fulfill their intended purpose due to a lack of clinical impact, operational feasibility, and input from envisioned operators. To be successful, they must fit into existing clinical decision-making models and be designed in collaboration with end users. We describe a case study of the development of a new low-cost sensor for antimalarial drugs, from initial planning through collection and incorporation of design feedback to final assay design. The assay uses an aptamer-based sensor to detect antimalarial drugs from patient samples for tracking antimalarial use in Southeast Asia, a region with a long history of emerging antimalarial drug resistance. Design and use-case input was collected from malaria control experts, researchers, and healthcare workers to develop target product profiles. Data was collected via surveys and in-person interviews during assay development and ultimately informed a change in assay format. This aptamer sensor platform can be easily adapted to detect other small molecule and protein targets and the design process described here can serve as a model for the development of effective new assays to improve access to healthcare technology.
即时检测方法极大地增加了获取诊断信息的途径，并在全球范围内改善了医疗保健成果，特别是在农村地区的热带疾病方面。对这些工具影响的认识不断提高、资金投入增加以及技术进步导致了新检测方法开发的激增。然而，由于缺乏临床影响、操作可行性以及预期操作人员的参与，许多新工具未能实现其预期目的。要取得成功，它们必须融入现有的临床决策模型，并与最终用户合作设计。我们描述了一个开发新型低成本抗疟药物传感器的案例研究，从最初的规划到收集和纳入设计反馈，再到最终的检测方法设计。该检测方法使用基于适体的传感器从患者样本中检测抗疟药物，以追踪东南亚地区抗疟药物的使用情况，该地区长期存在抗疟药物耐药性问题。从疟疾控制专家、研究人员和医护人员那里收集了设计和用例输入，以制定目标产品概况。在检测方法开发过程中通过调查和面对面访谈收集数据，最终为检测方法形式的改变提供了依据。这种适体传感器平台可以很容易地进行调整，以检测其他小分子和蛋白质靶点，这里描述的设计过程可以作为开发有效新检测方法的模型，以改善医疗技术的获取。
