Validation of quality assurance systems for aquatic diagnostic facilities

5 Validation of quality assurance systems for aquatic diagnostic facilities 

Validation is an integral part of any QA system. The importance of the validation step is to determine and prove the quality of the test and so the 

All tests performed within the disease diagnostic facility should be valid, irrespective of their purpose. The validation process determines that the assay flt-for-purpose, it ensures that it has been properly developed, optimised and standardised for the intended purpose. This is described in more detail in chapter 1.1.2 in the OIE manual for diagnostic tests in aquatic animals (www.oie.int). Emphasis is placed on the purpose of the assay, which should be clearly defined by the diagnostic laboratory, irrespective of where this has been developed. 

Selection of the various laboratory tests under the quality management system will influence the validity of the results obtained. This process is similar whether the laboratory is part of a fuUy accredited scheme or not. Importance can be placed on the internationally approved but also the scientific acceptance of the different laboratory tests employed. The methodology does not always have to be the most modem method used and in fact, often traditional, simple tests can be more cost effective within a rural aquatic disease diagnostic laboratory. 

Reference laboratories are important resources within animal disease diagnosis. These are internationally recognised facilities that have a combination of skilled personnel, validated diagnostic tests, reagents and appropriate archive material. The European Union Reference Laboratory (EURL-FISH) is funded by the EU Commission and is located in the national veterinary institute, Aarhus, Denmark. The main purpose of the EURL is to ensure high quality of all fish diagnostics performed in the member states of the EU. Furthermore this aids in the harmonisation of the protocols and methodologies applied for the various fish diseases, as described in Council Directive 2006/88/EC. The EURL is primarily concerned with notifiable viral diseases of fish (www.crl-fish.eu). 

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