The OIE launches a new procedure for validation and certification of diagnostic tests

The diagnostic methods for specific animal diseases are described in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (the Terrestrial Manual) and the OIE Manual of Diagnostic Tests for Aquatic Animals (the Aquatic Manual). However, these manuals do not recommend specific diagnostic kits that can be used by Member Countries. Consequently the existence of several such kits has led to possible confusion in some Member Countries, which are not comfortable to choose approved diagnostic kits for trade or surveillance purposes.

In accordance with OIE missions to control animal diseases, to harmonise animal diseases control methods including the harmonisation of diagnostic methods, the OIE International Committee adopted during the 71st General Session in May 2003, Resolution No. XXIX, endorsing the principle of validation and certification of diagnostic assays (test methods) for infectious animal diseases by the OIE. The Resolution asked the Director General of the OIE to set up specific procedures to be followed for the validation and certification of diagnostic assays, based on the fundamental concept of ‘Fitness for Purpose’. The OIE has, with the technical support of the OIE Collaborating Centres of Vienna (Austria) and Fougères (France), finalised a formal procedure for the validation and certification of diagnostic kits. This procedure is open to both public and private laboratories producing diagnostic kits and which are desirous of having those kits approved and registered at the OIE.

Assessment of the diagnostic kit will be carried out by independent experts and the results submitted for consideration by the Biological Standards Commission before being endorsed by the OIE International Committee during the annual General Session. This procedure may last approximately for 135 days for each application. If the diagnostic test is validated and certified by the OIE, the producer would be authorised to use the OIE logo on any document or equipment associated with the test.

June 7, 2005

Original web page at OIE