Department of Chemistry and Chemical Biology, Harvard University, 12 Oxford St., Cambridge, MA 02138 (USA).
Angew Chem Int Ed Engl. 2015 May 11;54(20):5836-53. doi: 10.1002/anie.201411741. Epub 2015 Apr 27.
Despite the growth of research in universities on point-of-care (POC) diagnostics for global health, most devices never leave the laboratory. The processes that move diagnostic technology from the laboratory to the field--the processes intended to evaluate operation and performance under realistic conditions--are more complicated than they might seem. Two case studies illustrate this process: the development of a paper-based device to measure liver function, and the development of a device to identify sickle cell disease based on aqueous multiphase systems (AMPS) and differences in the densities of normal and sickled cells. Details of developing these devices provide strategies for forming partnerships, prototyping devices, designing studies, and evaluating POC diagnostics. Technical and procedural lessons drawn from these experiences may be useful to those designing diagnostic tests for developing countries, and more generally, technologies for use in resource-limited environments.
尽管高校在即时检测（POC）诊断全球健康方面的研究有所增长，但大多数设备从未离开过实验室。将诊断技术从实验室转移到现场的过程——旨在根据实际条件评估操作和性能的过程——比看起来要复杂得多。两个案例研究说明了这一过程：开发一种用于测量肝功能的基于纸张的设备，以及开发一种基于水多相系统（AMPS）和正常细胞与镰状细胞密度差异来识别镰状细胞病的设备。开发这些设备的详细信息提供了形成合作伙伴关系、设备原型设计、研究设计和评估即时诊断的策略。从这些经验中吸取的技术和程序教训可能对那些为发展中国家设计诊断测试的人以及更普遍地对在资源有限的环境中使用的技术有用。
