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Guidelines for applicants for OIE Reference Laboratory status

OIE Reference Laboratories must provide evidence of scientific leadership and of the capability to fulfil the Terms of Reference: all applicants should preferably be the national reference laboratory; they should be able to receive samples from other countries for diagnostic testing; they should demonstrate the capability and willingness to organise rather than just participate in proficiency tests; they should be capable of providing confirmatory diagnostic services, reference materials, training, etc., internationally; and the designated expert should have a number of recent relevant publications in peer-reviewed journals.

Applications should be submitted 45 days before the date scheduled for the meetings of the relevant Commission (Biological Standards Commission: 8‒12 February 2021, and Aquatic Animal Health Standards Commission:17‒24 February 2021; the next deadline is therefore 23 December 2020 for OIE Reference Laboratories for terrestrial animal diseases and 2 January 2021 for aquatic animal diseases). The 45-day period gives the OIE sufficient time to screen, translate into English when necessary, and process the dossiers for the Commission’s evaluation. Deadlines must be strictly observed to allow a full evaluation of the dossiers by the members of the Commission prior to its meeting. Applications received after the deadline will be examined in the next meeting of the Commission.

Applications shall be submitted in accordance with Article 1 of the Internal Rules and should include the following information:

1. Name of expert (a curriculum vitae using this template).

2. Name and address of laboratory (telephone and e-mail address [fax numbers or Web site, if available]).

3. Name of the Head of laboratory (Responsible Official).

4. Demonstrate that legal and budgetary provisions are in place that provide assurance on the sustainability and functioning of the laboratory.

5. Provide documented proof (certificates) of accreditation to the ISO 17025 or equivalent quality management system in diagnostic laboratories, ideally with relevant tests included in the scope of the accreditation.

6. Give details of experience in diagnostic testing for the disease according to the OIE Standards nationally and internationally (approximate number of tests performed annually for each technique).

7. Provide additional information on expertise in diagnostic techniques (agent characterisation techniques, molecular techniques, monoclonal antibody techniques, etc.), epidemiology and control of the disease.

8. Give details of experience in standardisation and validation of diagnostic tests.

9. Demonstrate reagent production capability (provide details of current stock of reagents for the disease).

10. Demonstrate capability for timely international shipment and receipt of samples in accordance with the requirements for postage and packaging of biological materials described in the OIE Manual of Diagnostic Tests and vaccines for Terrestrial Animals, and the OIE Terrestrial Animal Health Code or the OIE Aquatic Animal Health Code.

11. Provide guarantees to ensure that staff respect the confidential nature of certain subjects, results or communications.

12. Provide a list of completed research and methods development projects on the disease.

13 Provide a list of inter-laboratory proficiency tests that the laboratory regularly organises and participates in.

14. Provide a list of collaboration agreements with other laboratories, centres or organisations.

15. Give details of training and consultation experience for the disease in the last 2 years (courses provided, number of people trained, examples of international consultation).

16. Provide a list of scientific meetings that the laboratory has organised and participated in.

17. Provide a list of reference documents (chapters for the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, OIE Manual of Diagnostic Tests for Aquatic Animals, disease cards, etc.) to which the laboratory contributed.

The application will be processed by OIE in accordance with Articles 2, 3 and 4 of the Internal Rules.

A short summary of activities of relevance to the status of OIE Reference Laboratory (no more than one page) should be included.

Applications comprising the information requested in all the above-mentioned points must be no longer than 15–20 pages in A4 format, single-spaced using Times New Roman font size 10 pt. The application must be prepared in one of the official languages of the OIE (English, French or Spanish).