Development and Commercialisation of a Second Generation Rapid Diagnostic Test (RDT) for Human African Trypanosomiasis (HAT) and other Kinetoplastida

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

Abstract

The overall aim of this research is to complete the further development and commercialisation of new tests for the detection and diagnosis of the parasite Human African Trypanosomiasis (HAT or sleeping sickness), building upon and completing previously funded BBSRC applications. HAT threatens 43.4 million people in the sub-Saharan area of Africa, is the result of infection by parasites transmitted by the tsetse fly, and the development of new, more reliable and economic diagnostic biomarkers and assays is essential, particularly for surveillance and to curb transmission in the remaining moderate to high risk foci. Our approach is also amenable to the development of new diagnostic tests for the diagnosis, monitoring and surveillance of other diseases caused by parasite diseases. We will therefore also apply our technology to the development of new diagnostic tests for other diseases caused by Trypanosomes and Kinetoplastid diseases of commercial and social importance.

Publications

10 25 50
 
Description We have optimised the development of a rapid diagnostic assay for sleeping sickness that can be used in the field to detect infection with the causative parasite. This test is now undergoing a field trail alongside other potential tests to determine if it offers superior performance. Alongside this we are developing such rapid diagnostic tests for other neglected tropical diseases by generating recombinant antigens, including animal forms of diseases.

A key findings is that, by using alternative expression systems to develop antigens for rapid-point-of-care diagnostics, we are able to generate tests for African sleeping sickness that are more sensitive than existing tests. We believe this is due to the nature of the expression system used, whereby the system has the ability to produce post-translational modifications on the antigen that mirror those that the parasite itself would undertake and present to the immune system. The recombinant antigens are therefore more likely to recognised by a persons own antibodies to the parasite that causes sleeping sickness, resulting in a more sensitive test.
Exploitation Route Currently the tests are undergoing field trial in Africa. If successful this could result in the adoption of our test for sleeping sickness diagnosis and monitoring as a recommended test. These tests will be on-going for several years and are still in process at the time of writing. Both the tests developed within this project, but also the approach of using an alternative expression system to develop antigens tailored to the organism you wish to detect, can be utilised by others in developing new diagnostic tests.
Sectors Communities and Social Services/Policy,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

URL https://bbsrc.ukri.org/documents/1609-sleeping-sickness/
 
Description The rapid diagnostic tests have both a social impact and potentially economic. The rapid diagnostic test developed is currently under clinical field trial to determine the specificity and sensitivity in the filed and how this performs against competitor tests that have been developed.
First Year Of Impact 2016
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Cultural,Societal,Economic

 
Description Rapid diagnostic for sleeping sickness
Geographic Reach Africa 
Policy Influence Type Influenced training of practitioners or researchers
Impact Development of a diagnostic for sleeping sickness and travel of Dr Barrie Rooney to Africa to test for sleeping sickness. Discussion of diagnostics and approaches to develop these and link to treatment and monitoring of population.
 
Title Diagnostic fo African Sleeping Sickness 
Description Rapid point-of-care rapid diagnostic for sleeping sickness. Currently undergoing clinical trail in Africa. 
Type Of Material Technology assay or reagent 
Year Produced 2016 
Provided To Others? Yes  
Impact Awaiting results of trail. 
 
Description Development of diagnostics and treatments for dengue fever 
Organisation Mahidol University
Department Faculty of Tropical Medicine
PI Contribution Development of antibodies to Dengue fever for diagnostics and treatment. Collaborator has contributed knowhow and vectors for antibody sequences and we have generated expression vectors and ability to produce these antibodies in Chinese hamster ovary (CHO) cells.
Collaborator Contribution As above, gene sequences, DNA, plasmids and knowhow around antibodies against dengue fever.
Impact Collaboration between life scientists and clinical scientists.
Start Year 2018
 
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 Barrie Rooney spoke on BBC Radio Kent about working in Africa with contagious diseases 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Discussion afterwards.

Asked about tropical diseases.
Year(s) Of Engagement Activity 2014
URL http://www.bbc.co.uk/programmes/p027d7jt
 
Description Big Bang at Discovery Park 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Schools
Results and Impact Student and teacher evaluation suggest it was a day of 'awesome activities', 'wonderful activities' and STEM professionals who inspired the students to think they could and they can be successful in STEM'. Teacher feedback suggested that this was the best year yet and that it was a success in meeting the needs of their pupils.
Year(s) Of Engagement Activity 2016,2017,2018,2019
URL http://www.thestemhub.org.uk
 
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 Outreach Presentation on Diagnostics for Neglected Tropical Diseases 
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 Discussions and demonstrations on mass spectrometry analysis of recombinant biotherapeutic proteins and how these are expressed.
Year(s) Of Engagement Activity 2018
 
Description Royal Society Summer Science Exhibition 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact The Summer Science Exhibition is an annual display of the most cutting-edge science and technology in the UK. This free, week-long festival features exhibits and a series of inspiring talks and activities for all ages. Meet the scientists, discover the exciting research and technology they work on and have fun with great hands-on activities.
Year(s) Of Engagement Activity 2018
URL https://royalsociety.org/science-events-and-lectures/2019/summer-science-exhibition/
 
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