Skip to main content

Veterinary Validation of Point-of-Care Detection Instrument

Periodic Reporting for period 2 - VIVALDI (Veterinary Validation of Point-of-Care Detection Instrument)

Periodo di rendicontazione: 2019-07-01 al 2020-12-31

What is the problem/issue being addressed?
The VIVALDI project addresses the need for speed in the detection of unwanted microbial organisms in animal and food production. Simple, swift and reliable detection of these agents are critical for their monitoring and control.
Recent research efforts have been directed at the development of high throughput, fast and cheap diagnostic methods that can be used under field conditions as on-site tests in disease surveillance and control programs. However, these methods tend to remain as in-house methods in research laboratories.
The challenge in bringing such test tools to the market is to obtain international recognition of new on-site tests from Competent Authorities and trade partners.
The VIVALDI project will provide a fast technology (LAMP) for the detection of Avian influenza, Salmonella and Campylobacter and bring this through an official validation procedure to meet international standards and prepare this technology for commercial utilization.
Why is it important for society?
The EU is a global leader in animal health and food safety. However, it is still challenged by introduction of Avian influenza with devastating economic consequences for the poultry industry. Food-borne diseases caused by Salmonella and Campylobacter continue to be a burden to the population and healthcare systems.
A faster detection of these agents would greatly reduce this burden. Advancing the technological methods for this would benefit the EU population directly and assist the EU in maintaining its leading position within animal health and food safety. Global marketing of the technology of the VIVALDI project at the end of the project will strengthen the position of the European industry in the food safety testing market.
What are the overall objectives?
The cornerstone in international trade with animals and food is the mutual recognition of the disease status between trading partners. Therefore, the diagnostic methods applied should be trusted to provide reliable data on disease situation among countries. The World Organization for Animal Health (OIE) has approved existing methods and sets requirements for approval of alternative diagnostic methods.
Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs describes sampling and detection methodology for human pathogens in a wide variety of food categories. Detection methods should be approved by the International Organization for Standardization (ISO).
The VIVALDI consortium wants to bring a new technology for fast detection of pathogens through a comprehensive validation process to the point where the technology is ready for commercial exploitation. We will adapt the technology (the VETPOD system) for official validation for Avian influenza, Salmonella and Campylobacter by strictly adhering to the requirements of OIE and ISO.
A total of ten VETPOD instruments and 2,000 disposable polymer chips have been produced for the validation of the VETPOD system. Protocols and manuals on the use of the system in various sample types have been completed and distributed to partners that have also been trained during a 2-day training course.
For Avian influenza Raw materials (730 samples) have been collected and prepared for the internal validation. All the steps have been performed except for the determination of the relative diagnostic specificity and sensibility that will be achieved in the second semester of 2019.
For Salmonella and Campylobacter detailed plans and protocols for the internal and external validation process have been completed. A list of strains and materials (matrices) needed for the internal validation has been completed. However, work on these two pathogens is delayed due to the change of commercial partner in the project that has not yet been approved by the Commission.
In addition to the formal validation procedures required by OIE and ISO the VETPOD system is also being evaluated by end-users (private labs). Stakeholders willing to participate in the field evaluation of the VETPOD system have been identified. Collaborative work with end-users will commence after Summer 2019 when the partner private labs will receive the VETPOD instrument and the necessary number of chips.
Preparation for market uptake of the VETPOD system has been focused on market assessments for use and sales of the VETPOD system into the animal and food sector. Companies, associations, organizations and reference labs in Denmark, Italy, Germany, France and Sweden have been interviewed to assess market opportunities and how the VETPOD could be sold into EU countries.
The preliminary conclusions are that the VETPOD system appears to have considerable potential for detection of Avian influenza during outbreak and surveillance situations, and in surveillance programs for Campylobacter in live poultry. In food production (with expected low numbers of Salmonella and Campylobacter in the products) the necessity for an initial enrichment step does not appear to give the VETPOD system a clear competitive advantage over existing fast detection methods on the market.
The VETPOD system addresses the three most important zoonotic pathogens (Avian influenza, Salmonella and Campylobacter) within the poultry industry, but will also provide the pork and beef industry with a very useful tool for fast detection of these pathogens on farms and at slaughterhouses and meat processing factories.
The VETPOD system is suitable for field and on-site testing. It is portable, simple to use and can be operated by non-specialized personnel. The flexible design with different cartridges for specific pathogen targets and a common instrument allows the use in different user scenarios: Animal production, food industry, surveillance and control under the Competent Authority, etc. The VETPOD system is generic and eventually other target pathogens responsible for e.g. respiratory and alimentary infections in livestock and poultry can be included in the VETPOD portfolio.
Avian Influenza is one of the most feared diseases among poultry producers.
A portable reliable tool for rapid AIV detection as the VETPOD system able to provide fast diagnostic results in the hands of field veterinary personnel would greatly support decisions by the veterinary authorities on control measures like movement control, quarantine restrictions and stamping-out of index cases.
The two bacteria most harmful to food safety in the EU are Salmonella and Campylobacter. The European Food Safety Authority (EFSA) has estimated that the overall economic burden of human salmonellosis and campylobacteriosis combined could be as high as 5.4 billion € a year. A faster detection of these agents in food and animal populations would greatly reduce this economic burden, benefit the EU population and assist the EU in maintaining its leading position within animal health and food safety. Based on the progress in the project we are confident that the main goal of the project will be achieved, namely to bring a new technology for fast detection of pathogens through a comprehensive and internationally recognized validation process to the point where the technology is close to market and ready for commercial exploitation.
The first fully operational prototype of the VetPod system has been completed by DTU Nanotech!