Labormedizin - Nukleinsäuremetrologie NAM

• Forschungsstelle: METAS
• Projektnummer: F-5237.30111

Schlüsselwörter (Englisch)

Diagnostics, DNA, Health, Clinical Chemistry, Laboratory Medicine, Nucleic Acid, PCR, References, Reference Measurement Methods, Ring Comparisons, Traceability

Kurzbeschreibung (Englisch)

Switzerland invests substantially into the health of its 8.419 million inhabitants: 283 hospitals as well as 6'500 medical laboratories provide care for more than 4.9 million stationary or outpatient patients. Switzerland spends just under 81 billion francs (2016) in its healthcare system annually - accounting for around 12% of Switzerland's gross domestic product. Up to 70% of all medical decisions are at least in part based on laboratory analyzes, with a value of approximately 1.75 billion francs annually.

The need for traceable measurements is steadily increasing due to the high mobility of patients in Switzerland and the demographic trend towards an increasing average age of the population. A particular need for metrological services is expected by the current flood of analyzes and results in the field of personalized medicine, genomics and metabolomics, and it is important to be prepared for these developments. On an international level, the importance of metrology for laboratory medicine has ben and is clearly recognized, and substantial investments have been made by several NMIs for several years. ISO standards 17511 and 15189 have for years been specifying the need for metrologically traceable calibrators and reference materials. The metrologically still unsatisfactorily implemented situation has meanwhile improved. The new MDR (2017/745) and IVDR (2017/746) were put into effect on May 26, 2017, with the requirement to be implemented by May 26, 2022. The expanded regulations now also include details necessary and to be met requirements for the traceability of devices, calibrators, reference materials and measurement results as well as for the conduct of clinical studies.

Establishing the direct comparability of measured values must remain the main concern of metrology in the field of laboratory medicine. For this purpose, METAS is setting up a dedicated laboratory whose tasks include the production and distribution of higher-order laboratory medical reference measurement methods and materials. The primary goal is not to produce the highest precision in individual measurements, but rather to create a benefit for the individual patient by increasing the comparability of different analysis systems and laboratories. To this end, METAS enters the area of laboratory medicine, generating the Swiss capabilities for accurately measuring nucleic acids. It prepares reference materials in international cooperation and develops the necessary reference methods. METAS provides the necessary human as well as structural and organizational infrastructure, and actively develops the necessary skills. Nucleic acid metrology (NAM) at METAS actively participates in international collaborations and comparisons and relies within Switzerland on cooperation with other federal institutions. The NAM actively seeks to exchange and provide services for the Swiss industry, academia, administration and healthcare.

Projektziele (Englisch)

The aim is to set up a metrological laboratory for laboratory medical issues with a focus on nucleic acid metrology. For genetic testing, reference measurement methods and materials are developed, validated and provided. The benefit of metrologically traceable reference materials will be shown to the relevant medical professionals and other stakeholders using the example of relevant analytes. Their development and certification is carried out in collaboration with the Swiss industry, academia, administration and especially the health service. The established measurement capabilities and reference materials are internationally recognized by successful participation in key comparisons of the CCQM. Metrological knowledge will be passed on through trainings and workshops offered. Appropriate measures inform stakeholders about the benefit of metrology, and the concerns of metrology are disseminated popularly and scientifically. Wherever possible, we will make use of established federal laboratories and infrastructure. This project proposal includes the following specific objectives.

1. METAS has started metrological work in the area of laboratory medicine. A decision has been reached with respect to the need for ISO 17025, ISO 17034 and possibly 15189: 2012 or alternative certifications for the laboratory. An overseeing steering committee for laboratory medicine has been in operation, drawing on the abilities of representatives from METAS, laboratory medicine, industry and universities.

2. Collaboration and communication are successfully ensured. A stakeholder workshop was held at METAS. Ongoing visits to representatives of industry, academia and health professionals ensure the spread of the concerns of metrology. One to two co-operations with other METAS working groups have been completed and at least one international co-operation project has been carried out. These projects ideally resulted in at least one popular scientific or scientific publication each. A collaboration with another federal institution was carried out.

3. The qPCR and digital PCR systems as well as Next-Generation Sequencing methods were established as detection systems for nucleic acids at the METAS. Preparation methods for sepsis pathogens, HP viruses and neoplasia-associated nucleic acids as well as relevant control systems were established. From the available detection systems, ideal candidates for the further establishment of traceability were selected. Multiple methods for quantitative estimation of the number of pathogen DNA copies were selected per ml of blood or serum and cross-validated. Reference materials were purified, tested for purity, and the long-term stability of these materials began to be determined. Commutability of a select reference material was tested.