|
WORKPACKAGES
4.4. Work package descriptions
Workpackage 1 : Validation of existing NSP-tests
PARTICIPANTS
Partners 1, 2, 3, 4, 5, 7 and 8
Person-months per participant: 6 6 11 6 8 9 12
Start date or starting event: Month 1
OBJECTIVES
In the event of vaccination after an outbreak of FMD discrimination between vaccinated and infected animals will be crucial for the control and eradication. Currently there are three commercially NSP-tests available, but all have only been partially validated in different laboratories using different sera.
Objectives in this WP are:
- 1. Assay validation:
- 1.1. Determination of the diagnostic performances of NSP-ELISAs through the comparison with results from virological examinations in cattle, sheep, goats and pigs (WP3).
- 1.2. By validation in several laboratories, the robustness of the tests can be evaluated.
- 1.3. The diagnostic sensitivity will be determined by testing field sera (partner 8).
- 2. Calibration of NSP-based ELISAs through the use of reference standards and inter-laboratory check panels of sera for proficiency testing.
- 3. Improving diagnostic performance of the existing NSP-ELISAs.
- 1.1. Determination of the diagnostic performances of NSP-ELISAs through the comparison with results from virological examinations in cattle, sheep, goats and pigs (WP3).
- 1.2. By validation in several laboratories, the robustness of the tests can be evaluated.
- 1.3. The diagnostic sensitivity will be determined by testing field sera (partner 8).
Description of work:
- 1.1 Preparing calibration tools:
- Inventory of available sera (partner 3).
- Preparation of reference standard sera (partner 3) for a homogeneous calibration of NSP-test methods by using these sera as a dilution series in each panel (0-18 months).
- Preparation of panels of sera (covering different species, different immunological and infectious status, etc.) suitable for inter-laboratory diagnostic performance and proficiency testing (partner 2); these panels will be available through the selection of representative sera mostly deriving from the experiments carried out in this project (18-36 months).
- 1.2 Diagnostic performance with field samples
- Collection of samples in a field situation where FMD is present and vaccines are being used (Turkey, partner 8; Uganda, partner 4 in collaboration with the Ministry of Agriculture, Animal Industry and Fisheries, Uganda) and testing using all available NSP-assays (0-36 months). Results from this serosurveillance will also help to estimate adequate sampling strategies to provide evidence that FMD virus is not circulating in vaccinated animals.
- 1.3 Validation of diagnostic performance:
- Make an inventory of available sera for validation (partner 3).
- Sera from non-vaccinated/non-infected animals, as well as non-vaccinated/infected animals and vaccinated + infected animals will be tested (partners 1, 2, 3, 4, 5, 7 and 8).
- Sequential collection of various samples from vaccine/challenge animal experiments (WP4, 5 and 6) carried out in this project, including cattle, sheep, goats and pigs, and testing in parallel with virological assays and all available NSP-assays (partners 1, 2, 3, 4, 5, 7 and 8) (6-42 months).
- Scientific evaluation of the comparative validation results according to the OIE validation principles and using latent Class analysis (partners 1, 2 and 3) (36-48 months).
- 1.4 Improving diagnostic performance of the existing NSP-ELISAs:
- Existing NSP-ELISAs will be improved based on the validation outcome and determination of the diagnostic sensitivity (partners 2, 3, 4, 5, 7 and 8) (18 - 48 months).
- 1.5 Reports:
- Reporting results to the co-ordinating laboratory.- Publishing the results in a scientific article (24 -48 months)
Deliverables:
- D.7 - NSP standard reference sera and an inter-laboratory serum panels for proficiency tests.
- D.14 - Better knowledge of the impact of vaccination on virus circulation and improved sampling strategies.
- D.23 - Validated NSP-ELISAs to discriminate infected from vaccinated animals.
- D.24 - Improved NSP-tests and control strategy.
- D.50 - Reports: Scientific publications.
Milestones and expected result:
- M.1 - Finished inventory of the available sera (month 12).
- M.2 - Identification of reference standard sera (month 18).
- M.3 - Identifications of panels of sera for proficiency test (month 36).
- M.4 - Acquisition of results from testing of all field and experimental samples (month 42).
- M.5 - Validation status of existing NSP-assays: Comparative analyses and statistical evaluation of validation results from the different assays (month 48).
- M.6 - Improved NSP-assays (month 48).
|
|