Veterinary Validation of Point-of-Care Detection Instrument

Project Information

VIVALDI

Grant agreement ID: 773422

DOI

10.3030/773422

Project closed

EC signature date 10 October 2017

Start date 1 January 2018

End date 30 April 2022

Funded under

• SOCIETAL CHALLENGES - Food security, sustainable agriculture and forestry, marine, maritime and inland water research, and the bioeconomy

Total cost

€ 3 198 508,79

EU contribution

€ 2 918 817,84

Coordinated by

DANMARKS TEKNISKE UNIVERSITET
Denmark

Periodic Reporting for period 3 - VIVALDI (Veterinary Validation of Point-of-Care Detection Instrument)

Reporting period: 2021-01-01 to 2022-04-30

Summary of the context and overall objectives of the project

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 solutions that can be used under field conditions as on-site tests in disease surveillance and control programs. However, such 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 goals of the VIVALDI project are to 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.

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.

The World Organization for Animal Health (WOAH) 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 project has provided 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 has successfully been validated and certified by Nordval for the detection of Salmonella.

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

For avian influenza the internal validation has been completed. This has included determination of detection limit, repeatability, intermediate reproducibility, relative diagnostic specificity and sensitivity, and the results were satisfactory. The external interlaboratory validation has also been completed and the WOAH report has been completed. However, even if the results of the complete validation of the VETPOD method to detect avian influenza viruses are promising with good results for internal validation, the current relative diagnostic sensitivity of the method (74%) and the field validation results (good detection at the flock level, but less at the level of pooled samples) highlight the need of improvement of the viral RNA extraction step to increase the sensitivity of the method for positive approval by WOAH and AI EU-reference laboratory.

For Salmonella, the internal validation has been completed successfully. Samples were consequently analysed by 10 external laboratories producing 14 sets of data according to both the reference method and the VETPOD system. The results were satisfactory as the sensitivity of the VETPOD was found to be 99.46% and the specificity was found to be 98.21%. These are well within the acceptability limits of the validation body NordVal. NordVal have subsequently approved VETPOD as an alternative method for detection of Salmonella in food and has issued a certificate for use in samples of fresh and processed poultry and red meats, as well as ready-to-eat meat products.

For Campylobacter, the internal validation study has been completed. However, despite a considerable amount of optimizing the VETPOD for detection of Campylobacter the results of the internal validation did not meet the criteria required by the validation body NordVal. Thus, there were no basis for proceeding to the external ring trial and consequently, the method will not obtain official recognition by NordVal in its present state.
In addition to the formal validation procedures required by WOAH and ISO the VETPOD system was also evaluated by end-users (private labs). The field evaluation for zoonotic pathogen detection for Salmonella using the VETPOD system showed that the system is easy to use. It is a very fast system compared to the classic microbiology approach. While the classic approach takes 72 hours to gain results the VETPOD system provides results within about one day which is a clear advantage.

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.

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)

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 avian influenza virus (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 VETPOD system appears to have considerable potential for detection of avian influenza during outbreak and surveillance situations.

Globally, Salmonella is the most important food safety pathogen to be controlled by the food production industry. Action plans and control programmes in both the EU and internationally rely heavily on testing of samples along the food production chains, and it goes without saying that fast analysis results allow for fast action. Thus, the need for speed is imminent. VETPOD advances these possibilities as a portable reliable tool providing fast analytical results saving both analysis time and sample transportation time.

The first fully operational prototype of the VetPod system has been completed by DTU Nanotech