Plasmodium vivax is considered the most difficult species of human malaria parasite to eliminate because of the inability of conventional diagnostics to detect individuals who carry dormant liver forms and sustain malaria transmission. The consortium has developed the first diagnostic test that addresses this problem. PvSeroRDT aims to develop a point-of-care (POC) rapid diagnostic test (RDT) to transfer the consortium’s validated lab-based test to the field to support implementation of the P. vivax Serological Test and Treatment (PvSeroTAT) malaria control strategy. The PvSeroRDT specific objectives are: 1) Develop a POC RDT using lateral flow technology to measure antibodies to four P. vivax proteins that are biomarkers for the dormant liver-stage of P. vivax. 2) Establish Africa-based manufacturing capacity at DIATROPIX (Senegal) following RDT development at Abingdon Health, a UK-based SME specialising in lateral flow assays. 3) Validate RDT performance with bio-banked samples, followed by field-based clinical validation on freshly collected samples in Ethiopia and Madagascar. 4) Develop a clear regulatory strategy to streamline market authorization and access to this first-in-class P. vivax serological testing. PvSeroRDT addresses all expected outcomes and impacts of this call topic and work program, respectively. Specifically, it will contribute a robust POC diagnostic to the pipeline in sub-Saharan Africa (SSA) and enable the implementation of the AU-EU Innovation Agenda for public health. The project is designed to address the WHO’s preferred profile for P. vivax diagnosis, to translate an SME prototype to Africa-based industrial design, and to test clinical performance in several SSA sites, thus enhancing international cooperation in SSA and improving training opportunities in SSA. Ultimately, PvSeroRDT will facilitate implementation of PvSeroTAT – a new intervention for malaria elimination.
Fasciolosis is a major disease of cattle and sheep and is a key problem within the farming industry. It is caused by the parasite, Fasciola hepatica (a liver fluke), and is acquired by the ingestion of water or vegetation contaminated by the infectious stage of the parasite. The parasite goes on to colonise the liver of cattle and sheep where they feed on liver cells and blood. The presence of these parasites causes reduced milk yields, poor fertility and high perinatal loses, and chronic weight loss in cattle. In addition to these effects seen in cattle, acute disease can cause sudden death from haemorrhage and liver damage in sheep. These effects in turn cause economic losses, estimated to be £1312 million worldwide. Currently diagnosis of fasciolosis is based upon epidemiological data and blood samples (for raised liver enzymes) in the acute/sub-acute disease, and the demonstration of eggs in faeces in chronic disease. A number of enzyme-linked immunosorbent assay (ELISA) techniques have also been developed, however, both these and egg counts have to be carried out in central laboratories with the expertise to do so and can take several days to perform, thus there is a clear need for a simple rapid decentralised test. The project will aim to develop a pen-side lateral flow device (LFD) for the diagnosis of fasciolosis in cattle and sheep from faecal samples, with the aim of producing a simple to use, rapid test that will allow farmers and veterinarians to make informed decisions on whether treatment is required.
Since its emergence in 2011, Schmallenberg virus (SBV) has spread across most of the European continent. The virus causes a mild disease in adult sheep and cattle (fever, reduced milk yield and diarrhoea). However if an animal is infected during pregnancy, resultant offspring can have severe deformities. SBV is spread by biting midges making efforts to control it very difficult. The economic impact of SBV has been significant with some sheep farmers losing more than 30% of their lambs as well as lost milk production for dairy farmers. With a vaccine launch in the near future, control of SBV becomes possible, however farmers will have to make an economic decision as to whether the cost of vaccination outweighs the losses they are experiencing. This project will focus on developing cost-effective tests that can be used by farmers or vets to see whether animals are likely to be protected against infection. This information can be used to decide whether or not vaccination of some or all of the herd or flock is necessary. The tests will also be useful for confirming whether SBV is responsible for any deformed offspring before embarking on more expensive post mortem tests. This project will also produce information as to which parts of SBV stimulate a strong immune response. This is essential for developing refined vaccines and diagnostic tests. These tools will allow animals that have antibodies as a result of vaccination to be distinguished from animals that have been infected with SBV. This information will be vital for livestock exporters to regain access to markets outside of the EU that have implemented trade bans due to SBV. It will also allow monitoring of whether infection is occurring despite the use of vaccines.
Two Yorkshire based companies (Forsite Diagnostics Ltd and Aptamer Solutions Ltd) aim to collaborate through this feasibility study, to bring their individual expertise and harness the use of aptamers within routine development and subsequent and large scale production of lateral flow devices. If successful the methodologies developed will enable the routine use of aptamers in commercially available products through their existing contract service offers to fulfil the growing requirements for onsite or Point of Care testing, across life science industries.
Aptamers hold the potential to replace antibodies, traditionally used in lateral flow devices and enable tests to be developed which were previously impossible, not cost effective or lacked the performance required by the customer, to be developed, and exploited worldwide.
Sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria, affects 18 million people worldwide annually. Symptoms can be non-specific so there are often delays in diagnosis. It is rapidly progressive illness which, if untreated can result in major organs and body systems not functioning and eventually, death. In the UK, sepsis affects up to 64,000 annually - more than breast, bowel and prostate cancers combined. Simple, timely interventions including antibiotics and intravenous fluids can halve the risk of death.Unfortunately, current sepsis tests are unreliable, especially if the onset is rapid. Tests routinely used require a blood sample to be taken and sent to the laboratory, whilst the clinician waits for the results to make a decision. PROMPT-SEPSIS proposes a low-cost, rapid point-of-care diagnostic platform using a finger prick or saliva sample to provide a rapid result to guide clinical decision-making, allowing a potentially lifesaving treatment to commence promptly.
Background
The research work is being undertaken by a consortium of research and industry based technologists, scientists and poultry producers. The aim is to develop a rapid test system that can be used with great accuracy to evaluate on the farm whether the flock is carrying in its visceral tract the campylobacter’s of C Jejuni or C Coli.
The bacterium does not harm the birds but is a major human pathogen causing outbreaks at the level of between 70.000 and 300.000 cases per year in the United Kingdom.
We believe that via greater knowledge and a targeted response in the slaughter plant with increased carcass washing and the development of other factory interventions, we can reduce the human infection rate by up to 70%, saving the Health service considerable sums and reducing the human cost of many lost days off work.
Progress to date.
Selective studies have been undertaken to prove that the lamp assay process can show when either C Coli or C Jejuni are present. Further tests have then been undertaken to show that the response on the analyser to C Coli is dramatically different to that for S Aureus, L Monocytogenes, and S Epidermis. All of these tests have been successful.
We have then moved to assess at what levels of capture of the Campylobacter cells can we still get a distinctive and positive test result, having collected the organisms on beads encrusted with the antigen for the target bacteria.
Results at annealing temperatures.
Further work has been undertaken to show the effects of the tests on samples that have been selected using coated beads, and then the samples are heated to kill and break down the DNA of the target organism. This test group was also effective with a distinct and clear plot for the target organism and with no effect being seen from other bacteria tested alongside the campylobacter’s.
Progress
We are pleased with the progress and success of the work in the first quarter, and have progressed better than we had expected. Samples of faecal samples have been collected direct from turkey farms and further tests are being undertaken.
Second Quarter targets.
Additional verification work will be undertaken to verify the selectivity and to determine the detection limit of the assay. An internal amplification control will also be constructed and incorporated into the assay.
We hope to complete the instrument design specification, and continue with the electronics development. The concept is starting to look like a farm friendly process that can deliver accurate results even from lightly infected flocks, with very good accuracy, and with tests completed in well under an hour.
JEREMY HALL - Lead Co-ordinator and Industrial lead.
13 July 2012
Project Description
UK onion growers have invested heavily in technologically advanced drying, curing, refrigeration and controlled atmosphere storage systems designed to maintain availability of UK onions for up to 10 months, with gross annual production of around 400,000 tonnes, over 50% of UK annual consumption. The storage systems are effective in prolonging postharvest life, yet still the industry suffers from sporadic and unacceptably high incidences of internal disease. Rejection of complete lots with low levels of internal disease is a major problem. Main diseases are principally caused by Botrytis allii (neck rot) and various bacterial pathogens. Neck rot has become an increasing problem due to the recent withdrawal of thiabendazole (used as a seed dressing) in January 2010 (91/414/EEC).
In this project novel technologies are sought to address these issues, including the development of non-fungicide-based seed and set treatments as alternatives to thiabendazole, also a grower-friendly Botrytis-specific PCR/immunosensor field test to assess pathogen load and help assist managemant of the curing regime to suppress neck rot. Novel non-invasive technologies to rapidly detect internal disease in onion bulbs during grading and packing will also be researched to enable automatic rejection of internally diseased onions which cannot be seen by visual inspection.