International guideline for validation of diagnostic tests launched

In May 2005, the OIE (the World Organisation for Animal Health) launched a new procedure for validation and certification of diagnostic test kits. A key criterion in test certification is whether a test is"fit for purpose". This procedure is open to both public and private laboratories producing diagnostic kits.

The OIE (Office International Des Epizooties), created in 1924 by 28 member countries and currently including 167 members, is the World's body for harmonising animal disease control methods including diagnostic methods. The OIE has published manuals of diagnostic methods for specific animal diseases, such as. the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and the OIE Manual of Diagnostic Tests for Aquatic Animals. However, these manuals do not recommend specific diagnostic kits that can be used. Consequently, the existence of several such kits has created the possibility for confusion in some countries that are not comfortable at choosing the right kits for trade or surveillance purposes.

The initiative of establishing a certification / registration procedure came from the Joint FAO/IAEA Division, who has a mission to control animal diseases of importance by developing diagnostic methods and providing Member States advice and training in the use of these methods.

In recognition of the importance of quality control of diagnostic tests (or kits), the Joint FAO/IAEA Division has taken a leading role in formulating the guidelines for validation, through a series of consultations with experts over the past two years.

Talking about the launch of the certification procedure, an expert says: "This marks a large step forward improving quality of the kits available for end users in member states. It should greatly improve the quality of testing the kits and provide transparency of test data to allow end-users decide which kits are more suitable for their specific uses".