CCQM Task Group on Infectious Disease Diagnostics and Metrology for Pandemic Preparedness (CCQM-TG-PANDEMIC)

Date Established: August 2022

Status: Active

Terms of Reference

• To prioritize, with external stakeholders, proposed comparison activities to be addressed by the international metrology relating to rapid, deployable infectious disease diagnostics [Sub-Group 1].
• To document standardization approaches, that can be referenced in minimum acceptable product specifications for target diagnostic tests of particular diseases, for the prioritized measurands addressed by the international metrology community [Sub-Group 1].
• To develop knowledge transfer mechanisms and skills translation supporting the metrology of infectious disease diagnostics, within the international metrology community and to user communities [Sub-Group 2].

Sub-Group 1

• To develop proposals for measurands to be addressed by the international metrology community within CCQM WG ‘fire drill’ comparison exercises capable of demonstrating rapid deployable metrological response capabilities for infectious disease diagnostics and ensure that the proposals have been vetted for relevance and prioritized by the end-user community
  • First molecular exercise to be scoped, by the end 2022 with at least one further molecular and two other detection technology study proposals to be vetted and prioritized during 2023.
• To document standardization approaches for prioritized measurands addressed by the international metrology community that can be included in the desirable attributes of safe and effective in vitro infectious disease diagnostic products, including performance-related characteristics
  • Draft specifications to be produced by end 2022 with production and review of final specifications by end March 2023.

Sub-Group 2

• To develop eLearning modules on metrology for infectious diseases, deployable via the BIPM eLearning platform
  • Pilot modules to be developed by end March 2023 with testing and release by end June 2023.
• To develop best practice guidance on the importance, challenge and mechanisms for ensuring uniformity of measurements of infectious disease diagnostics, when using different measurement platform technologies/techniques. The guidance will be designed to:
  • Facilitate RMO capability maintenance/development
  • Guide community users, particularly in clinical settings, towards adopting clearly defined measurement units for the purposes of laboratory comparisons
  • Facilitate assay performance testing that will enable in vitro diagnostic (IVD) developers to navigate the regulatory approval process more adeptly
  • Provide metrology-based evidence to support regulatory decision-makers.
• To develop a paper on facilitating a more agile metrology workforce able to pivot to pandemic response when required.