Chagas disease (CD) affects about 7 million people worldwide, presents a large prevalence in Latin America, and is growing in the rest of the world, where congenital CD is the main mode of transmission. Point-of-care testing (POCT) methods are increasingly required to ease early diagnostics and increase treatment success. This work presents the development and validation of a smartphone-integrated ELISA-based POCT system for the detection of both chronic and congenital CD. Expensive and bulky equipment used for ELISA in conventional laboratories was replaced as follows. A miniaturized device was fabricated for incubation of commercial ELISA plates, achieving ∼±1 °C uniformity and stability. The ELISA plate reader was replaced by smartphone camera and image processing, comprising algorithms to account for variability sources and spatial light non-uniformity; thus, additional hardware like a dark-box is not required. The agreement between samples classified with this novel reading method vs. ELISA plate reader was found to be 99.7% and 95.4% for chronic and congenital CD, respectively. Furthermore, a smartphone application was designed and implemented to guide the user during the assay, provide connectivity, and access databases, facilitating patient monitoring and health-policy making. The whole system is aimed to be used as a practical diagnostic tool in primary health care settings, as well as to facilitate patients’ follow-up to provide better treatment. Concerning the technology itself, the proposed POCT platform is versatile enough to be readily adapted for the detection of other infectious diseases.

南美锥虫病 (CD) 影响全球约 700 万人，在拉丁美洲盛行，并在世界其他地区不断增长，其中先天性 CD 是主要传播方式。越来越需要即时检测 (POCT) 方法来简化早期诊断并提高治疗成功率。这项工作介绍了智能手机集成的基于 ELISA 的 POCT 系统的开发和验证，用于检测慢性和先天性 CD。传统实验室中用于 ELISA 的昂贵且笨重的设备被替换如下。制造了一个小型化装置用于商业 ELISA 板的孵化，实现了～±1 °C 的均匀性和稳定性。ELISA 酶标仪被智能手机摄像头和图像处理所取代，包括算法来解释可变源和空间光的不均匀性；因此，不需要像暗箱这样的额外硬件。对于慢性和先天性 CD，使用这种新型阅读方法与 ELISA 平板阅读器分类的样本之间的一致性分别为 99.7% 和 95.4%。此外，还设计并实施了一款智能手机应用程序，以在检测过程中指导用户、提供连接和访问数据库，从而促进患者监测和健康政策制定。整个系统旨在用作初级卫生保健环境中的实用诊断工具，并促进患者的随访以提供更好的治疗。关于技术本身，拟议的 POCT 平台具有足够的通用性，可以很容易地适应其他传染病的检测。