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Evaluation, verification and validation of commercial diagnostic kits

​​INIA's Animal Health Research Center (CISA) has several research groups specialized in infectious animal diseases that carry out evaluation, standardization and validation studies of diagnostic tests.

For the development of these studies, INIA-CISA has High Biological Safety Laboratories of Biological Containment Level 3 and 3+ (NCB3 and NCB3 +).

INIA-CISA is a facility with open access to institutes, universities, laboratories, private companies and national and international public administration that investigate animal health.

INIA-CISA develops evaluation, standardization and validation studies of diagnostic tests. The standardization and validation of the tests are tests that contribute to validate the efficacy and sensitivity of the kits and tests used in the diagnosis of diseases.

INIA-CISA focuses on the development of these tests related to animal diseases of economic importance for livestock and animal diseases of a zoonotic nature or of importance for public health, encompassed in the concept of “one health”.


  • 40 laboratories BSL-3 (WHO) and 2 laboratories BSL-4 (OIE) 
  • 15 independent experimental boxes at BSL-3 (WHO) for big and small animals and 4 boxes BSL-4 (OIE) adapted for in vivo experiments with zoonosis. 
  • The independent nature of each box allows different simultaneous experiments to be carried out with conditions adapted to each type of experiment. 
  •  Boxes are prepared to house small and large animals, both farm and wild, adapting the space to the needs of each species according to animal welfare regulations. 
  • Biosafety levels 3 (BSL3 (WHO)) and 3+ BSL (OIE)) allow the reproduction of animal diseases in vivo of importance in animal health and of a zoonotic nature. 
  • INIA-CISA is the only research centre in Spain that can investigate foot-and-mouth disease in laboratories and animals.

Frequent questions

What kind of R & D & I studies in diagnostics and vaccines can be carried out in high biosafety laboratories?

In high biosafety laboratories, evaluation, standardization and validation of diagnostic tests can be carried out; virus isolation, multiplication and sequencing. Work is also being carried out to evaluate antiviral treatments; biocidal evaluation; virus prevention, research for the development and evaluation of vaccines and other antivirals; immunological, virological and protection evaluation of new vaccines.

What type R & D & I studies in diagnostics and vaccines can be carried out in high biological security animal facilities?

In high biosafety animal facilities, in vivo reproduction of diseases can be carried out for the development of health studies, symptomatology and disease pathology. The action of the treatments and the expected effect of antiviral treatments, vaccine treatments and other antiviral components can also be evaluated in vivo, as well as immunological, virological and in vivo protection evaluation of new vaccines.

How can R & D & I studies in diagnostics and vaccines be requested to be carried out in the laboratories and high biological security animal facilities?

For open access to the network of high biosafety laboratories, the Public Access Protocol that describes the mechanism and criteria for access to the infrastructure must be followed ( ).

How can the request be formalized?

To formalize the request, you must have the support of a researcher working at INIA-CISA and request through, with a copy to and services from the Animal Research Centre to the General Subdirectorate for Research and Technology of the National Institute for Agricultural Research.

The email must indicate the name of the main researcher who will support the services in the INIA-CISA, the project to be carried out and the fiscal data of the company that will make the settlement effective (CIF and fiscal address).

Works can also be formalized through contracts and collaborations, in which an agreement must be reached that will be formalized in a contract.

Is a permit necessary for access to laboratories and animal facilities?

Access to the centre, laboratories and animal facilities is restricted, authorizations are granted to the different areas depending on the needs for the development of the works.

Is any type of specific training needed to work in high biosafety facilities?

Specific training in biosafety facilities is necessary, which varies depending on the biological agent with which one is going to work. The research centre has a biosafety service that teaches these courses, adapting them to the specific needs of each researcher.

Ask for more information​

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  • 916202300 

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