摘要
Background: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’.Methods: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.Discussion: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.
基金
On behalf of the WHA-WHO Demonstration Project,this work was granted by the United Nations Office for Project Services(UNOPS),in the context of the implementation of‘Development for Easy to Use and Affordable Biomarkers as Diagnostics for Types II and III Diseases’(Grant No.UNOPS/ANDI/G/2016/01)
It has also received the support of the National Key Research and Development Program of China(Grant No.2016YFC1202000,2016YFC1202003 and 2016YFC1200500)
the National Natural Science Foundation of China(Grant No.81101266)
the Fourth Round of Three-Year Public Health Action Plan(2015-2017)in Shanghai(Grant No.GWIV-29 and 15GWZK0101).
