Lubell-Doughtie Peter, Bhatt Shiven, Wong Roger, Shankar Anuraj H
Ona Systems Inc, Burlington, VT, United States.
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
JMIR Biomed Eng. 2022 Jul 29;7(2):e26800. doi: 10.2196/26800.
Precision public health (PPH) can maximize impact by targeting surveillance and interventions by temporal, spatial, and epidemiological characteristics. Although rapid diagnostic tests (RDTs) have enabled ubiquitous point-of-care testing in low-resource settings, their impact has been less than anticipated, owing in part to lack of features to streamline data capture and analysis.
We aimed to transform the RDT into a tool for PPH by defining information and data axioms and an information utilization index (IUI); identifying design features to maximize the IUI; and producing open guidelines (OGs) for modular RDT features that enable links with digital health tools to create an RDT-OG system.
We reviewed published papers and conducted a survey with experts or users of RDTs in the sectors of technology, manufacturing, and deployment to define features and axioms for information utilization. We developed an IUI, ranging from 0% to 100%, and calculated this index for 33 World Health Organization-prequalified RDTs. RDT-OG specifications were developed to maximize the IUI; the feasibility and specifications were assessed through developing malaria and COVID-19 RDTs based on OGs for use in Kenya and Indonesia.
The survey respondents (n=33) included 16 researchers, 7 technologists, 3 manufacturers, 2 doctors or nurses, and 5 other users. They were most concerned about the proper use of RDTs (30/33, 91%), their interpretation (28/33, 85%), and reliability (26/33, 79%), and were confident that smartphone-based RDT readers could address some reliability concerns (28/33, 85%), and that readers were more important for complex or multiplex RDTs (33/33, 100%). The IUI of prequalified RDTs ranged from 13% to 75% (median 33%). In contrast, the IUI for an RDT-OG prototype was 91%. The RDT open guideline system that was developed was shown to be feasible by (1) creating a reference RDT-OG prototype; (2) implementing its features and capabilities on a smartphone RDT reader, cloud information system, and Fast Healthcare Interoperability Resources; and (3) analyzing the potential public health impact of RDT-OG integration with laboratory, surveillance, and vital statistics systems.
Policy makers and manufacturers can define, adopt, and synergize with RDT-OGs and digital health initiatives. The RDT-OG approach could enable real-time diagnostic and epidemiological monitoring with adaptive interventions to facilitate control or elimination of current and emerging diseases through PPH.
精准公共卫生（PPH）可通过根据时间、空间和流行病学特征进行监测和干预，将影响最大化。尽管快速诊断检测（RDT）已在资源匮乏地区实现了广泛的即时检测，但由于缺乏简化数据采集和分析的功能，其影响未达预期。
我们旨在通过定义信息和数据公理以及信息利用指数（IUI），将RDT转变为PPH工具；识别可最大化IUI的设计特征；并为模块化RDT功能制定开放指南（OG），以实现与数字健康工具的链接，从而创建一个RDT-OG系统。
我们查阅了已发表的论文，并对技术、制造和部署领域的RDT专家或用户进行了调查，以定义信息利用的特征和公理。我们开发了一个范围从0%到100%的IUI，并为33种世界卫生组织预认证的RDT计算了该指数。制定RDT-OG规范以最大化IUI；通过基于OG开发用于肯尼亚和印度尼西亚的疟疾和新冠病毒RDT，评估其可行性和规范。
调查对象（n = 33）包括16名研究人员、7名技术专家、3名制造商、2名医生或护士以及5名其他用户。他们最关心RDT的正确使用（30/33，91%）、结果解读（28/33，85%）和可靠性（26/33，79%），并且相信基于智能手机的RDT阅读器可以解决一些可靠性问题（28/33，85%），并且对于复杂或多重RDT来说，阅读器更为重要（33/33，100%）。预认证RDT的IUI范围为13%至75%（中位数为33%）。相比之下，RDT-OG原型的IUI为91%。通过以下方式证明了所开发的RDT开放指南系统是可行的：（1）创建一个参考RDT-OG原型；（2）在智能手机RDT阅读器、云信息系统和快速医疗保健互操作性资源上实现其功能和能力；（3）分析RDT-OG与实验室、监测和人口动态统计系统整合对公共卫生的潜在影响。
政策制定者和制造商可以定义、采用RDT-OG并与数字健康倡议协同合作。RDT-OG方法可实现实时诊断和流行病学监测，并采取适应性干预措施，以通过PPH促进对当前和新出现疾病的控制或消除。
