Abstract：
Mycetoma is a neglected tropical disease caused by more than 70 different microorganisms and identified by the WHO as one of the high-priority diseases for developing diagnostic tests. To ensure the production of diagnostic assays for use by clinical staff in endemic regions, target product profiles (TPPs) were designed.
We describe the development of two TPPs: one for a diagnostic test able to identify the causative agent of mycetoma and another that would determine when treatment could be stopped. The TPPs were developed by considering product use, design, performance, product configuration and costs.
Version 1.0 TPPs for two uses were posted by WHO for a 1-month online public consultation on 25 October 2021, and the final TPP was posted online on 5 May 2022.
A major difficulty encountered in developing both TPPs was the large number of agents able to cause mycetoma and the lack of specific biomarkers for most of them.
We describe the development of two TPPs: one for a diagnostic test able to identify the causative agent of mycetoma and another that would determine when treatment could be stopped. The TPPs were developed by considering product use, design, performance, product configuration and costs.
Version 1.0 TPPs for two uses were posted by WHO for a 1-month online public consultation on 25 October 2021, and the final TPP was posted online on 5 May 2022.
A major difficulty encountered in developing both TPPs was the large number of agents able to cause mycetoma and the lack of specific biomarkers for most of them.
摘要：
目的：Mycetoma是一种被忽视的热带病，由70多种不同的微生物引起，并被WHO确定为开发诊断测试的高度优先疾病之一。为了确保为流行地区的临床工作人员提供诊断化验品的生产，设计了目标产品概况(TPPs)。
方法：我们描述了两种TPPs的发展：一种用于诊断测试，能够确定霉菌瘤的致病因子，另一种用于确定何时可以停止治疗。TPPs是通过考虑产品用途而开发的，设计,性能，产品配置和成本。
结果：世卫组织于2021年10月25日发布了两种用途的1.0版TPP，用于1个月的在线公众咨询，最终TPP于2022年5月5日在线发布。
结论：在开发这两种TPP时遇到的一个主要困难是能够引起菌丝瘤的药物数量众多，而且大多数药物缺乏特异性生物标志物。
方法：我们描述了两种TPPs的发展：一种用于诊断测试，能够确定霉菌瘤的致病因子，另一种用于确定何时可以停止治疗。TPPs是通过考虑产品用途而开发的，设计,性能，产品配置和成本。
结果：世卫组织于2021年10月25日发布了两种用途的1.0版TPP，用于1个月的在线公众咨询，最终TPP于2022年5月5日在线发布。
结论：在开发这两种TPP时遇到的一个主要困难是能够引起菌丝瘤的药物数量众多，而且大多数药物缺乏特异性生物标志物。
