1. Organisation Mondiale de la Santé Animale
Organización mundial de sanidad animal
World Organisation for Animal Health
(since 1924, Paris)

2. OIE Procedure for Validation and Certification of Diagnostic TestsBy
Dr Bernard Vallat Director general of the OIE

3. Introduction Background of the initiative Aim
Different steps of the Procedure
Website
News on the available guidelines and perspectives
News on the applications submitted to the OIE

4. Background of the initiative of this Procedure
► Historically, focus on tests methods mainly useful for trade and international movement of animals and animal products;
► With the expanding role of the OIE, it was necessary to evaluate more tests methods relative to specific diagnostic applications for surveillance;
► In collaboration with its international partners, recommendations were formulated and guidelines proposed (Consultant’s meeting in Vienna in November 2002 and December 2003);
► The resolution XXIX, at the 71st General Session of the OIE in May 2003, gave the Director General of the OIE a clear mandate to proceed with the establishment of a new process for the evaluation and certification of diagnostic tests;
► The OIE Procedure was launched in May 2005.

5. Aim of the procedure
Developed to meet the needs of Member Countries, the aim of this procedure is :
1. to validate and certify the ‘fitness for purpose’ of a diagnostic test.
2. to produce an OIE register of recognised diagnostic kits (available on the OIE web site).
All diagnostic tests for diseases, including zoonosis, caused by pathogens (viruses, bacteria, prions and parasites) present in terrestrial and aquatic animals can be validated and certified by the OIE procedure.

6. Aim of the procedure (contd)
The concept of ‘fitness for purpose’
Demonstrate population ‘freedom’ from infection (prevalence apparently zero)
a) ‘free’ with and/or without vaccination,
b) historical ‘freedom’,
c) re-establishment of ‘freedom’ following outbreaks;
Demonstrate freedom from infection or agent in individual animals or products for trade purposes;
Demonstrate efficiency of eradication policies;
Confirmatory diagnosis of clinical cases;
Estimate prevalence of infection to facilitate risk analysis (surveys, classification of herd health status, implementation of disease control measures);
Determine immune status in individual animals or populations (post-vaccination).

7. Procedure Before submission
Submission of the application to the Director General of the OIE
Applicable fee
Validation of the application by the OIESVCRDA
Scientific Evaluation
Biological Standards Commission’s opinion
Favorable opinion: end of the procedure
OIE Logo

8. Before Submission
Before submission, the applicant should fill in the Application Form (which can be downloaded on the OIE web site).
There are two main parts in this application:
General Information (Information about the applicant, Purpose of the test, Test Details, Technical Information about the test kit).
Validation Information (Repeatability data, Analytical specificity and Analytical sensitivity data, Diagnostic sensitivity and specificity data, Reproducibility, Laboratories where it is used).
The OIE Central Bureau, through the OIESVCRDA, is able to provide more procedural guidance during this pre-submission phase and to prepare the assessment process (date of submission).
Validation
Assessment
Notification
Decision
Meeting of the
BSC
International
Committee
Final decision
Dossier + Fees
Applicant Contact c c

9. Submission of the application form to the Director General of the OIE
Validation
Assessment
Notification
Decision
Meeting of the
BSC
International
Committee
Final decision
Dossier + Fees
Applicant Contact
The applicant should submit the completed application form (CD-ROM and one copy in paper format) and the relevant fee at the same time.
If possible, the applicant should provide with his application a ‘mock-up’ or specimen of the presentation of the diagnostic test ‘ready-to-use’.

10. The applicable fee
The assessment fee: €. The applicant shall pay this first part of the basic fee when he sends his dossier in order to start the procedure
The annual fee: 0.1% of pre tax annual cumulated turnover of the previous year gained from sale of the diagnostic test validated and certified by OIE. The applicant shall pay this second part of the basic fee, if the diagnostic test is validated and certified, in order to maintain it on the OIE register.

11. Validation of the application form by the OIESVCRDA
The OIESVCRDA will ensure that the application is complete, within 30 days following receipt of the dossier.
In the event that the OIESVCRDA requires additional data (the clock is stopped), the dossier could only be accepted after receipt and verification of the information submitted.
In case of a positive outcome, the OIESVCRDA will notify the applicant in writing that the dossier is acceptable. The names of the chairperson and the reviewers, the index number for the identification of the application and the timetable for evaluation will be attached to it.
Validation
Assessment
Notification
Decision
Meeting of the
BSC
International
Committee
Final decision
Dossier + Fees
Applicant Contact

12. Scientific Evaluation
Start of the procedure, as soon as each reviewer has receives the full dossier and OIESVCRDA the AR.
Validation
Assessment
Notification
Decision
Meeting of the
BSC
International
Committee
Final decision
Dossier + Fees
Applicant Contact
Day 1
Start of the procedure
D-30
Reviewer to provide a first report to the CRP
D-45
Draft assessment report from the CRP and potential questions sent to the OIESVCRDA (who sends the questions to applicant). If question: stop clock
D-46
Restart clock
D-60
Final assessment report sent to the OIESVCRDA and then from the OIESVCRDA to Members of the BSC
D-80
Comments from the BSC

13. BSC’s opinion
Validation
Assessment
Notification
Decision
Meeting of the
BSC
International
Committee
Final decision
Dossier + Fees
Applicant Contact
Day 120
BSC discussion, adoption of BSC’s opinion, BSC’s assessment report.
The OIE will ensure that the opinion of the BSC is given within 120 days.
Favorable Opinion: It is the end of the evaluation process
Unfavorable Opinion: An appeal procedure, which lasts 60 days, may be initiated by the applicant. In this case the clock is stopped.

14. Favorable opinion: end of the procedure
Validation
Assessment
Notification
Decision
Meeting of the
BSC
International
Committee
Final decision
Dossier + Fees
Applicant Contact
Day 130
Transmission to the OIE General Director
Day 135
Decision of the Central Bureau that the diagnostic kit is proposed for inclusion in the register. Notification to the applicant/ OIE approved number
Next International Committee meeting of the OIE: confirmation of inclusion in the register and update of the register within 7 days after the vote of the International Committee.
The producer is authorized to use the OIE logo on any relevant document or equipment associated with the test.

15. OIE Logo
The OIE validated and certified logo shall consist of the initials OIE taking the following form
Fitness for purpose validated and certified by OIE
Register number:
If the logo is reduced or enlarged the proportions must be respected.

16. OIE Web site and information about the procedure
The VCDA home page:

17. News on the guidelines available and perspectives
A special version of the application form with a guideline is now available for BSE. This was done in collaboration with the experts of the OIE ad hoc Group on BSE tests.
Other guidelines or application form could be in the future established according to the needs.

18. News on some applications submitted to the OIE
Dossier
Scientific assessment
Biological Standards Commission Decision
Area
Administartive checking
Start day of the scientific assessment
First report + list of questions
Replies from the applicant
Final report
BSE
Yes - 30/08/2005
26/04/2006
10/05/2006
Waiting for
Rabies
Yes - 28/03/2006
03/04/2006
01/05/2006
12/06/2006
27/10/2006
14/11/2006
WSSV
Yes - 28/04/2006
01/07/2006
16/08/2006 AI
Yes - 13/07/2006
01/08/2006
21/09/2006
11/02/2007

19. News on some applications submitted to the OIE

20. Conclusions – OIE Perspective
1. Improving documents available

21. Conclusions – OIE Perspective
2. Improving OIE Member Countries recognition of the standards for the validation and certification of diagnostic assays:
Resolution XXXII, 74th General Session, 2006, Recognition and implementation of OIE standards for the validation and registration of diagnostic assays by Member Countries:
“ The committee resolves that:
Member Countries of the OIE are encouraged to harmonise their standards for the validation and registration of diagnostic assays with the standards, guidelines and recommendations in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and where such standards are absent or not yet developed, to apply the standards in the Manual and in the OIE test register for the registration of such products within their countries.”

22. Conclusions – OIE Perspective
3. Improving communication on the procedure with the kits producers

23. World organisation for animal health
Thank you for your attention
World organisation for animal health
12 rue de prony
75017 paris, france
Tel: 33 (0) – Fax: 33 (0)