Influenza roadmap:
Diagnostic Tests
Roadmap for the development of diagnostic test for influenza
Download Influenza-diagnostic-development-roadmap2
Validation/ proficiency
Validation
Research Question
- Validation of diagnostics tools
Research Gaps and Challenges
- Validation of existing diagnostics against novel isolates
- Lack of harmonized validation protocols
- Development of internal controls that are standardized and readily shared
- Validation of portable PCR
- Validation of serologic DIVA tests to understand levels of sampling to achieve goal to show freedom from disease
- Understand how NGS can be used to supplement/augment PCR testing
- Validation of use for minor species (9000 avian species!!) and age of animal (e.g. piglets and sows)
- The chances of independent and external validation are rare and its cost may be expensive
- Lack of reference material
Solution Routes
- Standardization of methods across labs – ring trials
- Co-ordinated lines of reference material production
- Orchestrated collections of field material
- Improve broad detection, sensitivity and specificity of diagnostic tests
- Validation of portable PCR
- Validation of serologic DIVA tests to understand levels of sampling to achieve goal to show freedom from disease
- Understand how NGS can be used to supplement/augment PCR testing
- Public/private partnerships – letting private companies have access to samples and share technologies with companies despite restrictions in sampling handling of material from HPAI/regulated diseases
Dependencies
- Reference materials
- Organizational structures of concerted validation lines.
- Availability of economic resources
Projects
What activities are planned or underway?
Development of Vaccines for HPAI in Cattle, Turkey, Pigs, and Small Ruminants and Food Safety Studies Related to HPAI Virus in Food Products
Planned Completion date 25/08/2029
Source Countries:
United States
Intervention Strategies to Control Endemic and New and Emerging Influenza A Virus Infections in Swine
Planned Completion date 04/10/2026
Source Countries:
United States