Last update: 2nd December 2022
- Specialized diagnostic activity with different diagnostic methods (see below);
- Diagnostic approach in case of outbreaks, definition of control procedures, guidelines and managing of the disease in infected farms;
- Legislative support for the Ministry of Health and Veterinary Regional Officers.
Whit the aim of providing reliable analytical results, IZSLER works under a Management Quality Control System, which is based on the international UNI CEI EN ISO/IEC 17025 for accreditation of testing and calibration laboratories.
The adoption of such standards guarantees the technical competence, the reliability and the impartiality of the laboratory in performing the analyses. This, indeed, becomes an element for the recognition of the validity of the results at international level.
Today, IZSLER is enrolled on the register of Accredia (the national organization recognized for the accreditation of testing and calibration laboratories) as n. 0148 and includes 17 sites and numerous accredited methods.
The methods for direct diagnosis of paratuberculosis, cultural and PCR assays, have been developed “in house” and then validated and standardized. The methods for indirect diagnosis of paratuberculosis (i.e. milk and blood ELISA for detection of antibodies), are currently provided by commercial suppliers upon national tender.
Almost all the methods have been validated according to internal procedures which were largely inspired by the “Chapter 1.1.6. Principles and methods of validation of diagnostic assays for infectious diseases (version adopted in May, 2013). World Organization for Animal Health (WOAH, former OIE) (2016). – Terrestrial Animal Health Code, 25th Ed. WOAH, Paris, France” and by “ISO 16140: part 2 2016.”
The list of the methods is below reported (Table 1).
Table 1: List of methods used in order to diagnose Paratuberculosis
|Method||Matrix||Internal code||References||Accredited according to the ISO 17025|
|Cultural assay for detection of Mycobacterium avium subsp. paratuberculosis from milk||Milk from cow, sheep, goat or other ruminants||MP01/090||Bulletin of the International Dairy Federation N° 362/2001|
Butot S, Ricchi M, Sevilla IA, Michot L, Molina E, Tello M, Russo S, Arrigoni N, Garrido JM, Tomas D. Estimation of Performance Characteristics of Analytical Methods for Mycobacterium avium subsp. paratuberculosis Detection in Dairy Products. Front Microbiol. 2019 Mar 15;10:509.
|Cultural assay for detection of Mycobacterium avium subsp. paratuberculosis from faeces||Faeces from ruminants||MP01/207||OIE Manual for Terrestrial Animals 2021 cap 3.1.15 par 1.3||yes|
|ELISA for the detection of antibodies against Mycobacterium avium subsp. paratuberculosis. kit ID-Vet||Serum, whole blood and milk from cow, sheep, goat, buffalo||MP04/022||OIE Manual for Terrestrial Animals 2021 cap 3.1.15 par.2.1||yes|
|qPCR for the detection of the DNA of Mycobacterium avium subsp. paratuberculosis||Faeces, milk and tissues from cow, sheep, goat and other ruminants||MP09/078||Russo S, Giorgio G, Leo S, Arrigoni N, Garbarino C, Ricchi M. Validation of IS900- qPCR assay to assess the presence of Mycobacterium avium subs. paratuberculosis in faecal samples according to the OIE procedure. Prev Vet Med. 2022 Nov;208:105732. |
Butot S, Ricchi M, Sevilla IA, Michot L, Molina E, Tello M, Russo S, Arrigoni N, Garrido JM, Tomas D. Estimation of Performance Characteristics of Analytical Methods for Mycobacterium avium subsp. paratuberculosis Detection in Dairy Products. Front Microbiol. 2019 Mar 15;10:509
|Typing of Mycobacterium avium subsp. paratuberculosis by PCR for identification of type C or type S||DNA from Mycobacterium avium subsp. paratuberculosis field isolates||MP09/088||Collins D.M., De Zoete M.D., Cavaignac S.M. (2002): Mycobacterium avium subsp. paratuberculosis strains from cattle and sheep can be distinguished by a PCR test based on a novel DNA sequence difference. J.Clin. Microb. 40,12, 4760-4762||no|
|Identification of Mycobacterium avium subsp. paratuberculosis by f57-qPCR||DNA from Mycobacterium avium subsp. paratuberculosis field isolates||MP09/199||Ricchi M, Bertasio C, Boniotti MB, Vicari N, Russo S, Tilola M, Bellotti MA, Bertasi B. Comparison among the quantification of bacterial pathogens by qPCR, dPCR, and Cultural Methods. Front Microbiol. 2017 Jun 28;8:1174.||yes|