Home Coronaviruses [Validation] Validation
Coronaviruses roadmap:
Diagnostic Tests

Roadmap for the development of diagnostic tests for coronaviruses

Download 202410 Draft Coronavirus Diagnostic Development_Final

2

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