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Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：精确的公共卫生（PPH）可以通过以时间为目标的监视和干预措施来最大化影响，空间,和流行病学特征。尽管快速诊断测试（RDT）在低资源环境中实现了无处不在的即时测试，他们的影响小于预期，部分原因是缺乏简化数据捕获和分析的功能。
目的：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；确定设计功能以最大化IUI；并为模块化RDT功能制定开放指南（OGs），使其与数字健康工具链接以创建RDT-OG系统。
方法：我们审查了已发表的论文，并与技术领域的专家或RDT用户进行了调查，制造,和部署来定义信息利用的特征和公理。我们开发了一个IUI，从0%到100%，并为33个世界卫生组织资格预审的RDT计算了该指数。开发RDT-OG规格是为了最大限度地提高IUI；通过开发基于OGs的疟疾和COVID-19RDT，在肯尼亚和印度尼西亚使用，评估了可行性和规格。
结果：调查受访者（n=33）包括16名研究人员，7位技术专家,3家制造商,2名医生或护士，其他5个用户他们最关心RDT的正确使用(30/33，91%)，他们的解释(28/33，85%)，和可靠性(26/33，79%)，并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%)，读者对复杂或多重RDT更为重要(33/33，100%)。资格预审的RDT的IUI范围为13％至75％（中位数33％）。相比之下,RDT-OG原型的IUI为91%。通过（1）创建参考RDT-OG原型；（2）在智能手机RDT阅读器上实现其功能和功能，云信息系统,和快速医疗互操作性资源；以及（3）分析RDT-OG与实验室集成的潜在公共卫生影响，监视,和生命统计系统。
结论：政策制定者和制造商可以定义，采用,并与RDT-OG和数字健康计划协同。RDT-OG方法可以通过适应性干预措施进行实时诊断和流行病学监测，以促进通过PPH控制或消除当前和新出现的疾病。
目的：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；确定设计功能以最大化IUI；并为模块化RDT功能制定开放指南（OGs），使其与数字健康工具链接以创建RDT-OG系统。
方法：我们审查了已发表的论文，并与技术领域的专家或RDT用户进行了调查，制造,和部署来定义信息利用的特征和公理。我们开发了一个IUI，从0%到100%，并为33个世界卫生组织资格预审的RDT计算了该指数。开发RDT-OG规格是为了最大限度地提高IUI；通过开发基于OGs的疟疾和COVID-19RDT，在肯尼亚和印度尼西亚使用，评估了可行性和规格。
结果：调查受访者（n=33）包括16名研究人员，7位技术专家,3家制造商,2名医生或护士，其他5个用户他们最关心RDT的正确使用(30/33，91%)，他们的解释(28/33，85%)，和可靠性(26/33，79%)，并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%)，读者对复杂或多重RDT更为重要(33/33，100%)。资格预审的RDT的IUI范围为13％至75％（中位数33％）。相比之下,RDT-OG原型的IUI为91%。通过（1）创建参考RDT-OG原型；（2）在智能手机RDT阅读器上实现其功能和功能，云信息系统,和快速医疗互操作性资源；以及（3）分析RDT-OG与实验室集成的潜在公共卫生影响，监视,和生命统计系统。
结论：政策制定者和制造商可以定义，采用,并与RDT-OG和数字健康计划协同。RDT-OG方法可以通过适应性干预措施进行实时诊断和流行病学监测，以促进通过PPH控制或消除当前和新出现的疾病。
