Feasibility study with the recombinant protein, rISG65, in a new second generation Rapid Diagnostic Test (RDT) for Sleeping Sickness

Lead Research Organisation: University of Kent
Department Name: Sch of Biosciences


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Description We have developed a new rapid diagnostic test for the diagnosis of sleeping sickness. This is based upon findings from a FLiP award. Human African Trypanosomiasis (HAT, sleeping sickness) is a disease that threatens millions of people in the sub-Saharan area of Africa. The development of new, more reliable and economic diagnostic biomarkers and assays is essential, particularly for distinguishing between early and late stages of the disease to inform the drug regimen used if this disease is to be reduced further in the sub-Saharan. As such, some recent developments in this area have focussed upon identification and validation of new diagnostic markers of HAT to complement or improve upon the current Card Agglutination Test for Trypanosomiasis (CATT), whilst others continue to investigate the possibility of developing a vaccination to this disease. Hence, for both the development of new diagnostics and for potential new vaccines, the availability of appropriate expression systems for the generation of recombinant protein molecules is required.

He we have used existing expression systems and applied them to new areas of need/challenges with a view to create a new platform technology which could be used for tropical zoonotic diseases.

We have
1. Established a collaboration between the University of Kent and the charity Medecins Sans Frontieres (MSF).
2. Established the LEXSY expression system in the laboratory at Kent for the generation of novel antigens to use in new diagnostics for HAT.
3. Generated appropriate constructs for HAT antigens, and constructs for a model IgA for expression in the LEXSY expression system (Leishmania).
4. Undertake preliminary expression of the model antigen proteins by transforming Leishmania cells by electroporation and purifying the expressed proteins by His tag chromatography (for the tagged HAT antigens).
5. Begun to characterise the glycosylation of model proteins produced in LEXSY cells.
6. Begun to assess the antigenic properties of these targets in collaboration with the Tropical Institute of Medicine in Belgium.
8. Development of an ELSIA based diagnostic for HAT.
Exploitation Route Yes, we have a follow-on-fund to commercialise the new assay for use in the field and development of other tests for neglected tropical diseases
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

Description This work builds upon, and into on-going, work on the development of a rapid-point-of-care diagnostic for the detection and monitoring of sleeping sickness. It is based upon recombinant antigens generated in a unique expression system. Preliminary work with samples from the tropical institute in Brussels showed that the assay has suitable sensitivity and accuracy to distinguish between positive and negative samples. The diagnostic assay is currently being assessed In the field in Africa to help educate about sleeping sickness and undertake testing.
First Year Of Impact 2016
Sector Healthcare
Impact Types Cultural,Societal

Description Tropical Institute Collaboration 
Organisation Institute of Tropical Medicine Antwerp
Country Belgium 
Sector Academic/University 
PI Contribution Development of recombinant antigens for rapid diagnostic test for sleeping sickness.
Collaborator Contribution Providing serum and samples to test and validate antigens and diagnostics.
Impact Development of new diagnostic for sleeping sickness that is now in field trial in Africa.
Start Year 2014
Title A second generation Rapid Diagnostic Test (RDT) for Human African Trypanosomiasis (HAT) 
Description Currently in trial in Africa and being tested against other diagnostics to determine if the one developed during this project is superior. 
Type Diagnostic Tool - Non-Imaging
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2017
Development Status Under active development/distribution
Clinical Trial? Yes
UKCRN/ISCTN Identifier Not known
Impact Outreach and Dr Barrie Rooney awarded BBSRC Social Innovator of year. 
Company Name Trozon X 
Description The PDRA on the project has developed this spin out project and is the CEO. The aim of TROZON X is to design diagnostics for Tropical Zone Diseases which are easy to use in any environment. 
Year Established 2017 
Impact None yet.
Website http://www.trozonx.com
Description 7 open days at University 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Describing the research we undertake in the laboratory, covering all aspects of the research and the impact this has/can have. Particular questions around genetic modification of cells to produce recombinant proteins in all sessions and discussions around both the ethical aspects of this and the potential applications of such technology.
Year(s) Of Engagement Activity 2015,2016
Description Open day tours of research laboratory and discussions with participants 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact 8 days of open day activities.
Year(s) Of Engagement Activity 2017
Description Outreach Presentation on Diagnostics for Neglected Tropical Diseases 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Rotary Club Presentation on Diagnostics
Year(s) Of Engagement Activity 2016
Description School visit/outreach for several days at Simon Langton Boys Grammar - MBP2 project showing students how to clone, express and purify recombinant proteins in the laboratory and discuss science behind this. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Helping with research activity in school - cloning and expression of recombinant proteins
Year(s) Of Engagement Activity 2015,2016
Description Turkey Public Biotechnology Talk 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Presentation to public audience in Turkey on behalf of the British Council around biotechnology and its application. Event was filmed and followed by a question and answer session, answering questions sent in before the talk by social media and then from the audience. The event was filmed and shown on national TV in Turkey. Large range of topics discussed around the application of biotechnology to every day life and issues with long discussion/debate.
Year(s) Of Engagement Activity 2016
URL http://www.britishcouncil.org.tr/en/programmes/education/science-innovation-talks/biotechnology