13TSB_ENDANI_MilkED: Development of a point of need diagnostic test for infectious disease in milk
Lead Research Organisation:
University of Glasgow
Department Name: School of Engineering
Abstract
The 'MilkED' project is aimed at developing a device to rapidly detect pathogens in milk, within the milk parlour or milk tank. It is focused on Mycobacterium avium subspecies paratuberculosis (MAP), a pathogen infecting cattle and other ruminants, causing chronic diarrhoea, emaciation, and often leading to death. In addition to detrimental effects on the health of herds, leading to significant decrease in milk production, it is present in milk and resists pasteurisation, and may survive to be present in milk at the point of sale. Currently the detection process is lengthy and expensive and performed in a central laboratory.To prevent MAP entering the food chain and reduce the transmission of the infection within the animal population, we will develop a new device to test milk directly in the farm.
The "MilkED" industrial research programme is business led by a manufacturing company (Epigem), working in partnership with a medical diagnostics company (MV Diagnostics), in collaboration with a world leading University (Glasgow) in the field of advanced diagnostics. The consortium will build upon two technical innovations to develop of an easy-to-use rapid diagnostic device: (i) we will use sound waves, similar to the ones used for ultrasound imaging, to actuate liquids and process a small volume of milk (<1ml) within a disposable cartridge and drive a diagnostic test to a result, at low power (battery-operated), requiring virtually no training.(ii) We will fabricate microstructures akin to acoustic holograms to provide the sample processing functions on low-cost disposable devices, that are plugged in to a shoe-sized reader sitting next to the cow or milk tank.
The "MilkED" industrial research programme is business led by a manufacturing company (Epigem), working in partnership with a medical diagnostics company (MV Diagnostics), in collaboration with a world leading University (Glasgow) in the field of advanced diagnostics. The consortium will build upon two technical innovations to develop of an easy-to-use rapid diagnostic device: (i) we will use sound waves, similar to the ones used for ultrasound imaging, to actuate liquids and process a small volume of milk (<1ml) within a disposable cartridge and drive a diagnostic test to a result, at low power (battery-operated), requiring virtually no training.(ii) We will fabricate microstructures akin to acoustic holograms to provide the sample processing functions on low-cost disposable devices, that are plugged in to a shoe-sized reader sitting next to the cow or milk tank.
Technical Summary
The 'MilkED' project is aimed at developing a device to rapidly detect pathogens in milk, within the milk parlour or milk tank. It is focused on Mycobacterium avium subspecies paratuberculosis (MAP), a pathogen infecting cattle and other ruminants, causing chronic diarrhoea, emaciation, and often leading to death. In addition to detrimental effects on the health of herds, leading to significant decrease in milk production, it is present in milk and resists pasteurisation, and may survive to be present in milk at the point of sale. Currently the detection process is lengthy and expensive and performed in a central laboratory.To prevent MAP entering the food chain and reduce the transmission of the infection within the animal population, we will develop a new device to test milk directly in the farm.
The "MilkED" industrial research programme is business led by a manufacturing company (Epigem), working in partnership with a medical diagnostics company (MV Diagnostics), in collaboration with a world leading University (Glasgow) in the field of advanced diagnostics. The consortium will build upon two technical innovations to develop of an easy-to-use rapid diagnostic device: (i) we will use sound waves, similar to the ones used for ultrasound imaging, to actuate liquids and process a small volume of milk (<1ml) within a disposable cartridge and drive a diagnostic test to a result, at low power (battery-operated), requiring virtually no training.(ii) We will fabricate microstructures akin to acoustic holograms to provide the sample processing functions on low-cost disposable devices, that are plugged in to a shoe-sized reader sitting next to the cow or milk tank.
The "MilkED" industrial research programme is business led by a manufacturing company (Epigem), working in partnership with a medical diagnostics company (MV Diagnostics), in collaboration with a world leading University (Glasgow) in the field of advanced diagnostics. The consortium will build upon two technical innovations to develop of an easy-to-use rapid diagnostic device: (i) we will use sound waves, similar to the ones used for ultrasound imaging, to actuate liquids and process a small volume of milk (<1ml) within a disposable cartridge and drive a diagnostic test to a result, at low power (battery-operated), requiring virtually no training.(ii) We will fabricate microstructures akin to acoustic holograms to provide the sample processing functions on low-cost disposable devices, that are plugged in to a shoe-sized reader sitting next to the cow or milk tank.
Planned Impact
This project is targeted at the development of a point-of-need diagnostic device for the detection of Mycobacterium avium subspecies paratuberculosis (MAP) in milk. Its primary impact will be through the commercialization of the test and the economic and social benefits that accrue from this.
Target users and the wider public: MAP infection is present in approximately 35% of UK dairy herds. The bacterium can survive conventional Pasteurisation processes and may survive to be present in milk at the point of sale, with up to 3% milks samples from UK retail outlets contaminated. Although not proven there is a link between MAP infection and Crohn's disease in Man and there is a growing concern that MAP may represent a significant public health risk. To prevent MAP entering the food chain, there is a requirement to test milk, either at individual cow or bulk milk tank level. The test will use milk, thus not impacting animal welfare, in contrary to other tests (such as a skin test). The farmers will benefit from rapid information on the health of their herds, which will enable rapid control of the infection and decrease the impact on milk production, thus providing a global economic return. The wider public will benefit from increased control of the milk entering the food chain, thus potentially decreasing the impact contaminated milk has on human chronic conditions. This in turn will result in better health and reduced health costs.
The diagnostic device will use low-cost, low power technology, integrated into a disposable cartridge, processed by a reader. Requiring virtually no training, it will be carried out in the farm or dairy, significantly reducing the reliance on central labs and the environmental impact that sample transfer entails. The material technologies will reduce the impact on the environment.
Commercialisation: The consortium is focused on delivering a path for the commercialisation of the technology into a product to be placed within the farm or dairy. MAP infection occurs in most developed countries. In the UK the dairy cow population is 1.8 million animals in ~11,000 herds and approximately 35% of these herds are infected. Across Europe there are approximately 1 million dairy herds at risk from MAP infection, with a total dairy cow population at risk of 22.8 million animals. In the USA it is thought that 25% of dairy herds are infected. In India, where there are about 11 million dairy cattle, estimated seroprevalence in limited study of buffaloes and cattle suggested about 30% in both species. Initially targeting the UK with a reader and disposable cartridges (£7) results in a multi-million market, within which the technology developed has an attractive unique selling point.
Knowledge: Impact in terms of creation of knowledge will occur in the following areas. The ultrasound tools used to manipulate fluids, as well as the fundamental issues of creating complex flows, will all advance the field of lab-on-a-chip, medical diagnostics and fluidics. Demonstrations at UoG of the capabilities of the devices will provide valuable information for future users. Design parameters and libraries of translated functions (from phononic design to fluidic function) will enable a rapid turn-around of new systems, as well as basis for exploration to adapt them to other areas. The fundamental work on materials processing, including low cost devices, has the potential to impact many different diagnostic processes. Impact routes will be via conference presentations, journal publications and seminars and through the KTNs and external academic, industry and clinical facing organisations that the research team are members of. We will particularly target the diagnostic community with conference presentations at annual congresses. We will also link with industry towards delivering hands-on workshops with commercial products.
Target users and the wider public: MAP infection is present in approximately 35% of UK dairy herds. The bacterium can survive conventional Pasteurisation processes and may survive to be present in milk at the point of sale, with up to 3% milks samples from UK retail outlets contaminated. Although not proven there is a link between MAP infection and Crohn's disease in Man and there is a growing concern that MAP may represent a significant public health risk. To prevent MAP entering the food chain, there is a requirement to test milk, either at individual cow or bulk milk tank level. The test will use milk, thus not impacting animal welfare, in contrary to other tests (such as a skin test). The farmers will benefit from rapid information on the health of their herds, which will enable rapid control of the infection and decrease the impact on milk production, thus providing a global economic return. The wider public will benefit from increased control of the milk entering the food chain, thus potentially decreasing the impact contaminated milk has on human chronic conditions. This in turn will result in better health and reduced health costs.
The diagnostic device will use low-cost, low power technology, integrated into a disposable cartridge, processed by a reader. Requiring virtually no training, it will be carried out in the farm or dairy, significantly reducing the reliance on central labs and the environmental impact that sample transfer entails. The material technologies will reduce the impact on the environment.
Commercialisation: The consortium is focused on delivering a path for the commercialisation of the technology into a product to be placed within the farm or dairy. MAP infection occurs in most developed countries. In the UK the dairy cow population is 1.8 million animals in ~11,000 herds and approximately 35% of these herds are infected. Across Europe there are approximately 1 million dairy herds at risk from MAP infection, with a total dairy cow population at risk of 22.8 million animals. In the USA it is thought that 25% of dairy herds are infected. In India, where there are about 11 million dairy cattle, estimated seroprevalence in limited study of buffaloes and cattle suggested about 30% in both species. Initially targeting the UK with a reader and disposable cartridges (£7) results in a multi-million market, within which the technology developed has an attractive unique selling point.
Knowledge: Impact in terms of creation of knowledge will occur in the following areas. The ultrasound tools used to manipulate fluids, as well as the fundamental issues of creating complex flows, will all advance the field of lab-on-a-chip, medical diagnostics and fluidics. Demonstrations at UoG of the capabilities of the devices will provide valuable information for future users. Design parameters and libraries of translated functions (from phononic design to fluidic function) will enable a rapid turn-around of new systems, as well as basis for exploration to adapt them to other areas. The fundamental work on materials processing, including low cost devices, has the potential to impact many different diagnostic processes. Impact routes will be via conference presentations, journal publications and seminars and through the KTNs and external academic, industry and clinical facing organisations that the research team are members of. We will particularly target the diagnostic community with conference presentations at annual congresses. We will also link with industry towards delivering hands-on workshops with commercial products.
| Description | The 'MilkED' project developed a device to rapidly detect pathogens in feces, directly within the herd. It is focused on Mycobacterium avium subspecies paratuberculosis (MAP), a pathogen infecting cattle and other ruminants, causing chronic diarrhoea, emaciation, and often leading to death. In addition to detrimental effects on the health of herds, leading to significant decrease in milk production, it is present in milk and resists pasteurisation, and may survive to be present in milk at the point of sale. Currently the detection process is lengthy and expensive and performed in a central laboratory. To prevent MAP entering the food chain and reduce the transmission of the infection within the animal population, we have develop a new device to test cattle directly in the farm. The device is based on a new use of sound waves, which are able to impart energy to diagnostic samples, enabling to process them easily on a small, low-power platform, thus allowing directly at the farm. |
| Exploitation Route | In addition to the commercialisation activities by the companies involved in the consortium, as detailed above, the technology can be applied to a wide range of other pathogens/samples. The ability of the platform to handle feces can be used to detect biomarkers involved in colorectal cancer and neglected tropical diseases (such as Schistosomiasis). The ability to carry out a complete multiplexed DNA assay opens the possibility to use it to diagnose multiple diseases, including for example STIs in both veterinary and human applications. |
| Sectors | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Description | We have developed a methodology, along with the associated designs and prototypes, to carry out a complete multiplexed nucleic acid based assay, using surface acoustic waves, to detect mycobacterium paratuberculosis from fecal samples. From a sample of ca. 1g, we are able to extract DNA from the bacteria, amplify it on the device using PCR and detect the amplification specifically for 3 genes optically. These developments are now being used by the commercial partners Epigem Ltd, Enfer Diagnostics Ltd and SAW Dx Ltd in the project to build a commercial prototype, which will be validated on real samples from herds in Ireland. |
| First Year Of Impact | 2016 |
| Sector | Agriculture, Food and Drink,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Economic |