Coronaviruses roadmap:
Diagnostic Tests
Roadmap for the development of diagnostic tests for coronaviruses
Download 202410 Draft Coronavirus Diagnostic Development_Final2
Validation/proficiency
Validation
Research Question
- Validation of diagnostic tools
Research Gaps and Challenges
- Validation of existing diagnostics against novel isolates
- Lack of harmonized validation protocols
- Numerous potential host species/sample types, need host/sample agnostic approach or broad as possible
- Development on internal controls that are standardized and readily shared
- Validation of portable PCR tools
- Understand how NGS can be used to supplement/augment PCR testing
- Lack of reference materials/regulatory reference material distribution challenges
- Sample integrity can be an issue with field samples
- Validation for different species, including companion animals, and different matrix
- Consideration of in-field conditions for POCT and ease of use
Solution Routes
- Organization of ring trials in Corona PCR and NGS
- Co-ordinated lines of reference material production
- Improve broad detection, sensitivity, specificity and typing
- Validation of portable PCR
- Public/private partnership
- Validation of portable PCR for PanCoV (pan-SarbeCoV, pan-MerbeCoV) testing
- Available reagents (for non-human hosts?)
- Establishment of an international collaborative biobanking (virtual biobanking) system
Dependencies
- Organization of structure of concerted validation lines
Projects
What activities are planned or underway?
Differential susceptibility of SARS-CoV-2 in animals : Evidence of ACE2 host receptor distribution in companion animals, livestock and wildlife by immunohistochemical characterisation
Planned Completion date 26/07/2021
Participating Country(s):
Netherlands
Veterinary Biocontained facility Network for excellence in animal infectiology research and experimentation
Planned Completion date 28/02/2023
Participating Country(s):
Europe