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Development of a metrology framework

Development of a metrology framework (reference systems) enabling improved performance assessment and monitoring of end user molecular diagnostic methods for the detection of infectious diseases

The aim of this work package is to assess the potential of the methods developed under WP1 for establishing a reference system. Reference systems serve as anchor points over space and time for measurements and consist of reference methods of higher metrological order as well as of suitable reference materials which are used for calibration and performance control of end user (routine) assays.

The quality control and performance assessment of end user assays for pathogens is currently based on consensus methodology and reference materials and in the absence of suitable / matching calibration materials on theoretical considerations / assumptions. This leads to arbitrariness / analytical artefacts and lacking reproducibility of method performance assessments and calibrations. A combination of the methods developed and assessed in WP1, as well as the investigations under WP2 and WP 3, are expected to improve the situation.

The work package will concentrate on the identification of potential artefacts in qPCR assays, with the aim of eliminating the artefacts. The work package will further compare the performance characteristics of end user assays which will lead to recommendations to the scientific community on a suitable reference system for pathogens testing and how it could be established.

The workpage will investigate:

  • Definition of the working range of the desired reference system
  • Higher order reference system for bacterial DNA
  • Higher order reference system for viruses
  • Recommendations with regard to the establishment of a reference system for the NA based detection of viral or bacterial pathogens