Development and Validation of Diagnostic Methods in Animal Health
The validation of diagnostic methods in animal health is an essential process to ensure the reliability and accuracy of laboratory techniques used in the monitoring and control of infectious animal diseases.
This highly specialised and high-responsibility managerial role involves the evaluation, optimisation, and implementation of advanced diagnostic methodologies, ensuring their compliance with required quality standards and current regulations.
The validation of diagnostic methods in animal health is a fundamental process to ensure the reliability, reproducibility, and accuracy of laboratory techniques used in the monitoring, prevention, and control of animal diseases. This process guarantees that the methodologies employed are capable of providing reliable results, thereby contributing to the protection of animal health and public safety, particularly in relation to zoonoses, that is, diseases transmissible from animals to humans.
This highly specialised professional role involves the responsibility of evaluating, optimising, and implementing advanced diagnostic methodologies, ensuring their compliance with national and international quality standards, as well as with current regulations. The professional appointed to this role must possess a high level of technical and scientific expertise and solid experience in veterinary diagnostics, microbiology, and applied immunology.
Activities include performance assessment of diagnostic tests through studies of sensitivity, specificity, repeatability, and reproducibility, as well as comparison with recognised reference methods. Furthermore, updating and harmonising diagnostic protocols in line with scientific and technological advances is essential, ensuring the adoption of increasingly reliable and effective tools.
Another key aspect of the role involves training and providing technical support to diagnostic laboratories, so that validated methodologies are applied correctly and consistently across the national territory, particularly where National Reference Laboratories (NRLs) are present. Collaboration with research institutions, national reference laboratories, and both national and international health authorities also represents a crucial element in the development and implementation of strategies for the control of animal diseases.
In summary, this highly specialised professional role in the validation of methods in animal health carries significant responsibility. It requires a high level of competence and continuous professional development, with the aim of ensuring increasingly effective diagnostic tools for the protection of animal and public health, through the use of methodologies that comply with international standards and recognised accreditation processes.
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Manuela Tittarelli
Head
Graduated in Biological Sciences from the University of Bologna (1988). Registered in the national professional register of biologists (1990, no. EA_007475).
She currently holds a highly specialised executive position (Dirigente sanitario con incarico di altissima professionalità, effective from 2024).
She is Head of the National Reference Laboratory (NRL) for brucellosis, as well as of the National Reference Centre for brucellosis, and is responsible for the serum bank within the national network of bio-reagent banks.
Graduated in Biological Sciences from the University of Bologna (1988). Registered in the national professional register of biologists (1990, no. EA_007475).
She currently holds a highly specialised executive position (Dirigente sanitario con incarico di altissima professionalità, effective from 2024).
She is Head of the National Reference Laboratory (NRL) for brucellosis, as well as of the National Reference Centre for brucellosis, and is responsible for the serum bank within the national network of bio-reagent banks.
Her role includes responsibility for the validation and accreditation of testing methods used by the Animal Health Laboratory. This involves organising inter-laboratory comparison tests, validating reagents, maintaining updated lists of reference materials, and harmonising testing methods in accordance with the guidance of relevant national and European Union reference laboratories.
She collaborates with relevant departments within the Institute and with the network of IIZZSS laboratories in managing the activities of the NRL and the National Reference Centre for brucellosis. She also works in partnership with the EU Reference Laboratory (EU-RL) for brucellosis.
She manages and participates in national and international research projects and collaborates with WOAH reference laboratories and with FAO as a brucellosis expert. She organises and attends national and international conferences, both as speaker and participant.
She has been employed at IZSAM since 1992, when she was appointed Assistant Biologist (Level IX) after passing a public recruitment procedure based on qualifications and examinations (1990 call). Initially assigned to the Animal Health Laboratory and the Serology Unit, in 1994 she was entrusted with coordinating all technical and operational activities of the Serology Unit at IZSAM. She worked in the Immunology and Serology Unit for thirty years as Head of Unit (1994–2024), and since 2009 also as Head of the National Reference Centre for brucellosis.
Over the years, she has enhanced her professional development by attending numerous training courses and visiting various national and international animal health laboratories.
She is co-author of 89 scientific papers published in peer-reviewed journals (Scopus h-index: 16).
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