Comet

Workpackages

WP1 – Assessment (characterisation) of purity / identity of primary calibrators for calibration of RMPs and production of secondary CRMs and EQA materials

The aim of this work package is to characterise the purity of primary calibrators which will then be used in WP2 to calibrate the RMPs and possibly in WP3 to produce secondary CRMs and EQA materials by spiking the primary calibrator in a suitable matrix. This will be done for cyclosporine (Task 1.1), PTH (Task 1.2) and hCMV (Task 1.3) in order to improve the availability of fit for purpose calibrators and quality control materials.

In Task 1.1 and 1.2, the aim will be to develop new approaches (techniques) for purity assessment that makes the identification and accurate quantification of impurities more straightforward while reaching measurement uncertainties that are compatible with the medical need. Task 1.1. will use cyclosporine and Task 1.2 will use PTH as a model system.

In Task 1.3, the aim will be to refine the concept of purity and to develop new approaches (techniques) to confirm the identity of the target using hCMV as a model system.

For Tasks 1.1 –1.3, the planned work requires to i) carefully define the measurand and ii) to consider measurement uncertainty at each level of the calibration hierarchy and its impact on the overall quality of laboratory tests.

The outcomes will be then compiled in Task 1.4 to issue a report on the assessment (characterisation) techniques of purity (cyclosporine, PTH) / identity (hCMV) of primary calibrators for the production of secondary materials (CRMs and EQA materials).

WP Leader : PTB

WP2 – Automation and multiplexing techniques for high throughput RMPs

The aim of this work package is to develop new approaches to increase the throughput of reference measurement procedures through automation and multiplexing techniques.

In Task 2.1, an automated RMP for estradiol will be developed and their impact on SI-traceability will be evaluated.

In Task 2.2, an automated SI-traceable RMP for the multiplexed analysis of a panel of therapeutic drugs will be developed.

In Task 2.3, a high throughput, SI-traceable RPM for PTH will be developed.

The outcomes of Tasks 2.1, 2.2 and 2.3 will be compiled in Task 2.4 to issue a report on how throughput of RMPs can be increased through automation and multiplexing.

WP Leader : LGC at NML

WP3 – Commutability assessment of CRMs & EQA materials

The aim of this work package is to organise and implement at least 6 commutability studies with the objective i) to identify manufacturing processes enabling consistent production of calibration and quality control materials of high commutability levels, ii) to develop more efficient and cost-effective ways of conducting commutability studies and iii) to support a coordinated European metrology infrastructure (EMN TraceLabMed) working in close cooperation with EQA providers and IVD manufacturers with the aim of supporting post-market surveillance of IVD tests (WP4).

In Task 3.1, new approaches for commutability studies of CRMs and EQA materials will be designed. These new approaches will be implemented in a series of commutability studies: a panel of clinically relevant biomarkers (at least 2 measurands) (Task 3.2), neonatal bilirubin (Task 3.3), therapeutic drugs (Task 3.4), PTH (Task 3.5), hCMV (Task 3.6) and POCT for glucose (Task 3.7). In these different tasks, more efficient and cost-effective ways of conducting commutability studies will be achieved through:

  • The organisation of simplified commutability studies in which a lower number of patient samples would be used to evaluate commutability of new lots of CRMs and EQA materials (Task 3.1)
  • The organisation of multiparameter commutability studies, in which commutability of multiple CRMs and EQA materials will be evaluated simultaneously for a panel of measurands (Tasks 3.2 and 3.4)
  • The organisation of a 2-step commutability study, in which panels of fresh, single donor clinical specimens will be used in a first commutability study conducted in Task 3.2 and then be replaced by panels of frozen pools in the commutability study conducted in Task 4.2
  • The mutualisation of the resources and capabilities of a network reference measurement service providers forming a coordinated metrology infrastructure that would jointly assign reference method target values to clinical specimens, CRMs and EQA materials included in a commutability study (Tasks 3.2 to 3.7).
  • The development of automated statistical approaches making it possible to analyse commutability data much faster (Tasks 3.2 to 3.7)
  • Define needs, requirements and governance structure of a permanent organisation responsible for coordinating joint multiparameter commutability studies (Task 3.1).

WP Leader : NOKLUS

WP4 – European metrology infrastructure supporting the organisation of accuracy-based programs and EQA data aggregation for improved post-market surveillance of IVD tests

The aim of this work package is to support a coordinated European metrology infrastructure (EMN TraceLabMed) supporting continuous post-market surveillance of IVD tests by supporting or organising accuracy-based programs relying on commutable EQA materials with reference method target values.

In Task 4.1, the objective is to perform advanced post-market surveillance of IDV tests by assessing the harmonisation and trueness of IVD-MDs. This will be done through retrospective value assignment of reference method target values to EQA materials that were shown to be commutable (Task 3.2).

In Task 4.2, the objective is to organise a framework for performance verification of IVD tests and harmonisation monitoring of clinical measurements through global accuracy-based programs and EQA data aggregation. In the project, one large-scale EQAS will be organised for which 2 EQA materials will be produced in large amounts, tested for commutability, value assigned with reference methods and distributed in different European countries by multiple EQA providers. Using the 2-step commutability approach designed in A3.1.2, the partners will evaluate commutability of the EQA materials using commutability panels qualified in A3.2.8.

In Task 4.3, a framework for performance verification of IVD tests and harmonisation monitoring of clinical measurements through EQA data aggregation will be developed.

WP Leader : Sciensano