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EbolaMoDRAD Report Summary

Project ID: 115843
Funded under: H2020-EU.

Periodic Reporting for period 1 - EbolaMoDRAD (Ebola Virus: Modern Approaches for developing bedside Rapid Diagnostics)

Reporting period: 2015-02-01 to 2015-12-31

Summary of the context and overall objectives of the project

The overall aim of EbolaMoDRAD has been to develop and deliver rapid and bedside diagnostic tool(s) that will significantly increase our capacity to handle Ebola Virus Disease (EVD) in West Africa in the 2014-2015 and future outbreaks. This will/has been done via a multidisciplinary research consortium drawn from key European and African research organisations thus consolidating previous tools and knowledge.
Within the first period of the project we have developed several assays and protocols, which will facilitate achievement of EbolaMODRAD overall goals before end of the project. Partners have evaluated many conventional molecular tests that enable the best current diagnostics to be used based on evidence generated within this project. The project partners have also been developing novel ‘next generation PCR’ tests that go beyond the current molecular amplification tests and use cutting edge amplification, which is likely to lead to better, more rapid and portable diagnostics than currently available. We have also been evaluating the potential of inactivation of Ebola virus directly within the blood tubes at time of sampling as a way of making laboratory testing safer and more efficient. EbolaMoDRAD has/will also focused to put in place a strong capacity building programme in West Africa in the clinical aspects of EVD and also for fields’ diagnostics and outbreak management.
In addition, EbolaMoDRAD project aims to establish such a “disseminated” Biobank, which will create a platform for sharing the material and data possibly linked to them among the partners, in order to facilitate future research activities foreseen within the project. EbolaMoDRAD has disseminated widely all available results as they become available notably to public health bodies, non-govermental organisations (NGOs), outbreak management teams and local hospitals in West Africa via workshops, international and national congresses and meetings.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project is organised into five work packages (WP): the first one is dedicated to the management of the consortium and the organisation of annual and Executive Committee (ExCom) meetings. The Project Management Team has been acting as a helpdesk for all partners to answer their questions about the project, finances and help for reporting. The other WPs are dedicated development of the scientific aspects of the project and its dissemination.
Progress has been achieved in all aspects of the WP2. The main results are that a filter tip based extraction system is in development and a prototype has been made and now requires further testing.
Real-time PCR reagents have been evaluated and lead reagents identified for freeze drying in an easy-to –use format. Both simple and more complex viral extraction methods have been tested and evaluated. Direct inactivation of Ebola virus has been evaluated in Vaccum blood tubes and a method has been disseminated to all partners. All isothermal amplification methods (LAMP, RPA and hRCA have been evaluated are in various states of readiness. And finally a complete sample to answer format system is progressing from the constituent extraction and amplification parts into a system that will be able to generate results from crude samples.
In task 3.1, different Ebola proteins has been expressed and purified and used to immunize rabbits and chickens. Characterization of the antibody titers, specificity and functionality is in the process. We are also in process to develop monoclonal antibodies. Within the WP3 we scanned peptides covering 4 Ebolavirus proteins (have been successfully synthesized. 2 of them have been used for the production/printing of a 1st generation 16-well antigen microarray (see deliverable D 3.15). After further optimization of the print conditions, the microarray could be used for the characterisation and epitope mapping of several commercial antibodies from BBI solutions that had been employed in a prototype LFD assay by CORIS (partner 5, see task 3.3 and deliverable D3.15).
We have also developed the first immunochromatographic flow tests (LFD) with antibodies from commercial sources. These pre-prototypes have been evaluated with live viruses in BSL-4 laboratories of FoHM (partner 1).
In addition to these tasks, we are in the process to validate SOPs for vaccuum blood tube for serology. The Ebola inactivation experiments are being performed at FoHM under BSL-4 biosafety levels. The main objective of the work package 4 is to validate the analytical sensitivity and specificity of new diagnostic tools developed in WP2 and WP3 in the laboratories in Europe and in the field under very realistic conditions. This will be achieved using samples from diagnostic testing collected during the outbreak in West Africa and stored in the laboratories of the Institutions involved in the project, and samples collected in the framework of the project, which will be gathered in a “disseminated” BioBank and will be possibly linked to clinical and epidemiological data organised in a common Database. WP4 partners are making efforts to evaluate the availability of Ebola Disease Virus (EVD) samples in order to establish such a “disseminated” BioBank. For this purpose, a complete and detailed questionnaire has been elaborated and submitted to all participants involved in this task and the information obtained from the survey will be consolidate and used to set up the “disseminated” BioBank and a related Database
To start the field validation, multiple ethical clearance steps have been undertaken and the approval for the use of available samples collected in Sierra Leone has been finally obtained. Preliminary optimization testing on a prototype based on RT-PCR method developed within WP2, have been performed also in the field.
Moreover, due to the course of the epidemic and the closure of treatment centers and laboratories in the field and the difficulty of shipping and using in Europe th

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

A few progresses beyond the state of the art and the expected potential impacts have been noticed since the beginning of the EbolaMoDRAD project.
The major advances of the WP2 so far relate to the inactivation of Ebola virus in blood tubes. This is the first time the commonly used vacutainer tubes have been adapted for such purpose of inactivating Ebola virus, and offers the potential to significantly simplify Ebola nucleic acid sample testing as the need for dedicated biosafety containment may decrease, providing more rapid and easy to access diagnostics.
We have

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