National Institute of Parasitic Diseases (NIPD), Chinese Centre for Disease Control and Prevention, Shanghai, 200025, People's Republic of China.
WHO Collaborating Centre for Tropical Diseases, National Centre for International Research on Tropical Diseases, Key Laboratory of Parasite and Vector Biology of the Chinese Ministry of Health, Shanghai, 200025, People's Republic of China.
Infect Dis Poverty. 2017 Oct 2;6(1):130. doi: 10.1186/s40249-017-0344-9.
Interventions are currently being used against 'infectious diseases of poverty', which remain highly debilitating and deadly in most endemic countries, especially malaria, schistosomiasis, echinococcosis and African sleeping sickness. However, major limitations of current 'traditional' methods for diagnosis are neither simple nor convenient for population surveillance, and showed low sensitivity and specificity. Access to novel technologies for the development of adequate and reliable tools are expressly needed. A collaborative project between African Network for Drugs and Diagnostics Innovation and partner institutions in Africa and China aims to screen suitable serological biomarkers for diagnostic pipelines against these 'diseases of the poor'.
Parasite-specific exposed versus unexposed individuals were screened and sera or urine/stools were collected through case-control studies in China and African countries. Target genes/open reading frames were selected, then will be cloned and cell-free expressed, quantified and immuno-detected. Target antigens/epitopes will be probed and screened with sera from exposed or unexposed individuals using a high-throughput antigen screening platform as the study progresses. The specificity and sensitivity of highly immunoreactive biomarkers will be evaluated as well, using enzyme-linked immunosorbent assays or dipsticks.
This roadmap explicitly unfolds the integrated operating procedures with focus on malaria and schistosomiasis, for the identification of suitable biomarkers that will aid the prioritization of diagnostics for population use. However, there is need to further validate any new diagnostic through comparison with standard methods in field deployable tests for each region. Our expectations for the future are to seek regulatory approval and promote the use of diagnostics in endemic areas.
目前正在针对“贫困相关传染病”采取干预措施，这些传染病在大多数流行国家仍然具有高度致残性和致命性，尤其是疟疾、血吸虫病、包虫病和非洲昏睡病。然而，当前用于诊断的“传统”方法存在重大局限性，既不便于人群监测，也缺乏敏感性和特异性。迫切需要获得开发充足和可靠工具的新技术。非洲药物和诊断创新网络与非洲和中国的合作机构之间的一个合作项目旨在筛选针对这些“穷人病”的诊断管道的合适血清学生物标志物。
通过在中国和非洲国家的病例对照研究，筛选寄生虫特异性暴露和未暴露个体，并收集血清或尿液/粪便。选择目标基因/开放阅读框，然后进行克隆和无细胞表达、定量和免疫检测。随着研究的进展，将使用高通量抗原筛选平台，用暴露或未暴露个体的血清探测和筛选目标抗原/表位。还将使用酶联免疫吸附测定或试纸来评估高免疫反应性生物标志物的特异性和敏感性。
本路线图明确阐述了侧重于疟疾和血吸虫病的综合操作程序，以确定合适的生物标志物，从而有助于将诊断重点优先用于人群使用。然而，需要通过与每个地区可现场部署测试中的标准方法进行比较，进一步验证任何新的诊断方法。我们对未来的期望是寻求监管批准，并促进在流行地区使用诊断方法。
