18NET02 TraceLabMed: Support for a European Metrology Network on

• Forschungsstelle: METAS
• Projektnummer: F-5237.30117

Schlüsselwörter (Englisch)

Laboratory Medicine, In vitro Diagnostic Medical Devices, European Reference Laboratories, Proficiency Testing Schemes, External Quality Assessment, Reference Measurement Procedures, Certified Reference Materials

Kurzbeschreibung (Englisch)

Metrologically-based quality assessments (QA) of clinical laboratory testing for in vitro diagnostic devices (IVD) are now compulsory for meeting the new European In-Vitro Diagnostic Device Regulation (IVDR) 2017/746 which requires traceability of values assigned to calibrators and control materials. To support the needs of the IVDR, EURAMET has approved a European Metrology Network (EMN) on Traceability in Laboratory Medicine. The EMN brings together metrology institutes and key stakeholders in this field, such as proficiency testing (PT) providers, clinicians, and regulators. The main goals of the EMN are to identify and prioritise stakeholder needs, to coordinate the provision of services, and to foster the development of new standards in order to support the IVDR. The EMN to be established will be a central point of contact for calibration and reference laboratories as well as for IVD manufacturers to ensure the traceability of their procedures and IVDs to metrological reference points according to the requirements of the IVDR 2017/746. This project aims to support the associated EMN by developing plans and strategies for a joint European metrology infrastructure for traceability in laboratory medicine, including processes for initiating and promoting dialogue amongst NMIs/DIs and stakeholders and by developing a coherent strategy for a Pan-European response to the legal requirements of the IVDR on a sustainable basis.

This is a joint network project carried out in the framework of the European Metrology Programme for Innovation and Research (EMPIR) (see:http://www.euramet.org/research-innovation/empir/). The EMPIR initiative is co-funded by the European Unions's Horizon 2020 research and innovation programme and the participating states. METAS is one of the project partners in the project

Projektziele (Englisch)

The overall aims of this project are to formally integrate existing PT schemes for reference laboratories into the associated EMN infrastructure and to develop a joint strategy to identify and prioritise measurands for laboratory medicine for which SI-traceability needs to be provided. The project addresses the following objectives:

1. To develop a plan for a joint sustainable European metrology infrastructure for traceability in laboratory medicine by stimulating smart specialisation of European NMI facilities and services. This should include processes to promote a constructive dialogue between NMIs/DIs and stakeholders such as clinicians, national medical associations, External Quality Assurance (EQA) providers, regulators and IVD manufacturers.
2. To create a coherent strategy for a joint European response to the need for traceability in laboratory medicine and IVD producers in this field, in accordance with the IVD Regulation (EU) 2017/746. This response should accommodate the need for sufficient redundancy while avoiding unnecessary duplication of work. A web portal serving as a single access point should direct customers’ requests for specific calibration services and reference materials to the service providers.
3. To develop a joint strategy with EQA providers for reference laboratories to identify and prioritise measurands for which SI traceability is required. Existing national priority lists should be utilised to identify a core set of measurands to start with. Reference points in proficiency testing schemes for SI-traceable measurements should be provided. With input from clinical research and national medical associations, the strategy should also propose additional candidate measurands for future EQA schemes.
4. To assess and report on the benefits of establishing a legal framework for coordinated action of the EMN, preferably underpinned by EURAMET as the legal body responsible for the collaboration of NMIs and DIs in Europe. To develop processes whereby regular consultation within the network on a long-term basis, can enable the EMN to work towards binding commitments among the members as well as to agree on a common quality infrastructure.
5. To set up a roadmap addressing the further development of the EMN both regarding timing and content of the activities and services offered. Broadening the scope of the activities may include but is not limited to engagement with (a) clinicians, to support the identification and quantification of novel biomarkers and the definition of more reliable clinical thresholds, (b) IVD manufacturers, to provide tools for the metrological validation of new assays in accordance with the new IVD Regulation (EU) 2017/746, (c) emerging European NMIs/DIs or even non-EU countries, to organise knowledge transfer by provision of support and training such as staff exchange and the organisation of interlaboratory tests.

Abstract (Englisch)

METAS's contribution to the success of the network was as follows:

During the reporting period, a website was created with the help of the project manager to position the EMN in the field of metrology for corona diagnostics 
(https://www.euramet.org/european-metrology-networks/laboratory-medicine/tlmcoronavirus-response/)was created. The project leader also hopes that the use of the coronavirus website will lead to an intensified discussion on the fundamental positioning and self-image of the network.

The Swiss analysis list (https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherungleistungentarife/Analysenliste.html) and information on Swiss stakeholders in the field of laboratory medicine were made available to the network. 

Discussions have begun in the network on the selection of an initial comparator (= proficiency test material), which will be used to demonstrate the added value of metrological traceability. This selection has not yet been finalized and will certainly still take some time. 

The stakeholder workshop to be organized at METAS, which was originally planned for 2020 is possible in the following year at the earliest and in consultation with the EMN.

A publication on the topic of "Traceable measurement for medicine" in MetInfo 1/2020 - with planned republication in the journal Chemiextra - also provides information about the work of the EMN. 

The EMN's work is also listed on the project website of the large-scale nucleic acid metrology project 
(https://www.metas.ch/metas/de/home/fue/forschungsprojekte/Nukleinsaeure.html)

Umsetzung und Anwendungen (Englisch)

The existence and benefits of an EMN (TraceLabMed) were communicated at the highest level by METAS in the "Report in fulfillment of postulate 12.3716 Kessler of 13.09.2012", published on November 20, 2019. Wherever possible, the EMN is named as a contact and linked accordingly. This applies in particular to initial exploratory talks with Qualab, which is responsible for quality assurance in laboratory medicine. In addition, a publication on laboratory medicine in MetInfo 1/2020, the web presence of nucleic acid metrology on METAS.ch, and the resulting social media presence were used to draw more attention to the existence and benefits of the network. However, no Swiss stakeholder has officially joined the EMN Laboratory Medicine yet, but various Swiss stakeholders are already being invited to become members of the Support group for the large-scale nucleic acid metrology project (5237.30111; from SwissMedic, ZLM Inselspital, Laboratory Medicine Basel, FGCZ Zurich and a private laboratory) are also informed every six months about progress in the EMN.

METAS has been an active partner in the network in recent months. It has not only supported the development of the network, but has also initial services of the network (on reliable data on the economic benefits of traceability in laboratory medicine; response still pending).