The problem: testing takes time, and it can be dangerous
Rapid diagnosis is imperative for controlling Ebola outbreaks. Early symptoms like fever and fatigue are the same for numerous other tropical diseases, so identifying the culprit is not easy without laboratory tests. Usually, samples need to go to specialised containment facilities to run the right tests, but due to weak infrastructure and a lack of sophisticated testing centres in the areas where Ebola outbreaks typically occur, it can take many days and up to a week to get results. There is an obvious need for a reliable, mobile and biosafe testing tool that can return results quickly and thus reduce the chances of the disease expanding further into the population. This would allow patients to be isolated straight away, and to target their close social circle for vaccination.
A test to detect (and deactivate) Ebola
The first hurdle for the EbolaMoDRAD project partners was to come up with a way of handling blood samples without creating any risk for the people who are responsible for taking, working with or transporting the samples. The project partners did this by creating a vacuum collection tube filled with an inactivation liquid that deactivates the virus itself while keeping the genetic material stable for about five weeks. This eliminates the need for a glovebox-equipped lab. Diagnosis is carried out on the spot, using the lateral flow dipstick test, eliminating the need for high-spec equipment or expertise.
The researchers tried out different techniques for detecting the infection in the blood, such as looking out for the virus itself, or looking for immune responses that would point to an infection. Apart from the rapid lateral flow assay, one of the most promising methods is gene detection by isothermal amplification. The project pitted different methods against each other to pick the best performing method. They also developed a pipette tip extraction, a battery-operated extraction method to single out the Ebola material so that the whole process is less dependent on electricity. Using samples gathered during the 2013-2016 outbreak, the researchers were able, with the help of local NGO Emergency, to test out the efficacy of the tools in Sierra Leone.
The legacy: teaching the tools
Once the project partners had achieved their mission of developing an Ebola test that was biosafe, specific, sensitive, rapid and simple to use, they set about the practicalities of making sure the local population would be able to use the technology independently. They organised a number of well-attended workshops in order to teach local groups in west African countries the necessary skills and procedures. Specifically, the workshops covered outbreak management, diagnostics and the use of diagnostic tools and how to interpret the results. They also organised hands-on training in neighbouring but non-epidemic countries.
Access to more (and more varied) expertise
Though the challenge itself was rather broad, the technical issues encountered during the project were very specific and complicated – and as such the mixed bag of expertise from the project partners was considered extremely beneficial. There were 18 partners, who knew they had to bring together whatever research and expertise was already out there, and most importantly, use the combined experience and expertise of a group to fix problems that would be next to impossible with an individual organisation.
The IMI-funded VHFMoDRAD builds on the achievements of EbolaMoDRAD which aims to develop a test capable of detecting a number of diseases related to Ebola. Both projects are part of the IMI Ebola+ programme.
Achievements & News
When it comes to Ebola, diagnosing infected patients quickly and accurately is key to controlling the spread of the virus. However, this can currently only be done in relatively sophisticated laboratory settings, which may be many miles from affected areas.### To tackle this problem, IMI’s EbolaMoDRAD project is developing and validating new diagnostic tests for Ebola that can be carried out wherever patients are located, quickly and safely, without the need for highly technical laboratory equipment or training. The project researchers have investigated various techniques for detecting the Ebola virus infection in blood samples, including testing for the presence of the virus itself and measuring molecules that reflect the immune response to viral infection.
The most promising method is known as isothermal amplification, which detects the genetic material inside the virus. Unlike other gene detection methods that require samples to be taken through multiple cycles of heating and cooling over several hours, isothermal amplification is carried out at a constant temperature of around 60⁰C and takes less than an hour. The team is now validating the test with samples collected from infected patients in West Africa, ensuring that it is accurate, sensitive and reliable enough to be used in the field. As well as detecting Ebola, the isothermal amplification technique can also be adapted to diagnose other similar viruses, such as the Marburg virus. ‘If there is an outbreak of a new disease we can add that to the test and we can detect several viruses with just one assay,’ says project coordinator Ali Mirazimi of Sweden’s Public Health Agency. ‘It is challenging but if we are ready for the next outbreak we can make a difference.’
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When it comes to Ebola, one of the major challenges in the field is rapid diagnostics without having to transport suspected patients to major hospitals.### Processing blood samples in the field or in small hospitals was not a good option until now because transporting blood tubes with the virus is a biosafety hazard and laboratories handling these samples need to have high containment facilities. Now there might be a new solution. Researchers working on IMI’s EbolaMoDRAD project found a way to inactivate the Ebola virus so it can be safely handled and transported. They did this by adapting the commonly used vacutainer tubes in a way which deactivates the virus during the sampling procedure, while preserving the virus RNA for at least 5 weeks independently of the storage temperature. The new invention, which was recently published in the Journal of Clinical Microbiology, reduces the risk of disease transmission during the handling of the samples; makes it possible to perform diagnostics in basic laboratories which may lack the high containment facilities; and makes it safer to transport patients’ samples from smaller hospitals to reference diagnostic laboratories. Although this method was developed in a lab, it is ready to be used in the field and can be validated quickly in the early stages of the next outbreak. In the long run, the EbolaMoDRAD project aims to develop and validate in the field rapid diagnostic tools that will be both simple and safe to use in low resource settings by people who may not have had specialist training.
ParticipantsShow participants on map
Universities, research organisations, public bodies, non-profit groups
- Department of Health, Leeds, United Kingdom
- Emergency Life Support For Civilian War Victims Ong Onlus, Milan, Italy
- Folkhalsomyndigheten, Solna, Sweden
- Institut National De La Sante Et De La Recherche Medicale, Paris, France
- Institut Pasteur, Paris, France
- Institut Pasteur De Dakar, Dakar, Senegal
- Istituto Nazionale Per Le Malattie Infettive Lazzaro Spallanzani-Istituto Di Ricovero E Cura A Carattere Scientifico, Rome, Italy
- Kobenhavns Universitet, Copenhagen, Denmark
- Statens Serum Institut, Copenhagen S, Denmark
- Stockholms Universitet, Stockholm, Sweden
- The University Of Stirling, Stirling, United Kingdom
- Universite D'Aix Marseille, Marseille, France
- University of Helsinki, University of Helsinki, Helsinki, Finland
- University of Turku, Turku, Finland
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Clonit SRL, Milano, Italy
- Coris Bioconcept SPRL, Gembloux, Belgium
- Inserm Transfert SA, Paris, France
Non EFPIA companies
- Aj Innuscreen GMBH, Berlin, Germany
|Name||IHI funding in €|
|Aj Innuscreen GMBH||175 000|
|Clonit SRL||251 250|
|Coris Bioconcept SPRL||318 125|
|Department of Health||310 625|
|Emergency Life Support For Civilian War Victims Ong Onlus||200 078|
|Inserm Transfert SA||231 000|
|Institut National De La Sante Et De La Recherche Medicale||224 106|
|Institut Pasteur||173 040|
|Institut Pasteur De Dakar||216 250|
|Istituto Nazionale Per Le Malattie Infettive Lazzaro Spallanzani-Istituto Di Ricovero E Cura A Carattere Scientifico||308 750|
|Kobenhavns Universitet||312 500|
|Statens Serum Institut||208 375|
|Stockholms Universitet||207 000|
|The University Of Stirling||279 836|
|Universite D'Aix Marseille||207 084|
|University of Helsinki||146 250|
|University of Turku||115 000|
|Total Cost||4 300 935|