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Forschungsstelle
METAS
Projektnummer
F-5237.30114
Projekttitel
18HLT03 SEPTIMET: Metrology to enable rapid and accurate clinical measurements in acute management of sepsis

Texte zu diesem Projekt

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Schlüsselwörter
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Kurzbeschreibung
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Projektziele
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Abstract
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Umsetzung und Anwendungen
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Erfasste Texte


KategorieText
Schlüsselwörter
(Englisch)

Infection, sepsis, biomarker, antimicrobial resistance, diagnosis, point of care

Kurzbeschreibung
(Englisch)

The overall aim of SEPTIMET is to improve the speed, accuracy and reproducibility of diagnostic tests for the identification and treatment of sepsis. Sepsis is a life-threatening infection where time to diagnosis is critical to patient outcome. This clinically driven project will develop and characterise reference systems to support confident application of existing tests and investigate metrological support for new and innovative approaches that offer the next generation of diagnostic solutions. Moreover, the outcomes of the project will also support IVD manufacturers, aiming to develop fast tests to support sepsis treatment, in meeting developments in EU diagnostic regulation.

This is a joint research 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 goal of the project is to enable the SI traceable measurement of established and new biomarkers to rapidly diagnose and guide treatment of sepsis. The specific objectives are:

  1. To improve the traceability and accuracy of measurements of established biomarkers, (e.g. C-reactive protein and procalcitonin), used for sepsis diagnosis. This will include the development of validated methods with target improvements to measurement uncertainties of <20 % and traceable materials for single and simultaneous, multiple sepsis biomarker measurements, as well as the definition of reference ranges of biomarkers in patients who are at risk of sepsis. 
  2. To develop a metrological and quality assurance framework for current methods used to confirm the microbiological cause of sepsis. This will include an evaluation of the accuracy and reproducibility of current methods and the quantification of target levels of accuracy and reproducibility required for quality assurance. 
  3. To develop improved reference methods to reduce uncertainties to <30 % and enhance reproducibility of rapid near patient (point of care) testing for sepsis (diagnosis and to guide treatment). Such methods must be suitable for accreditation and meet EU Directive 98/79/EC regulations. In addition, to develop an associated proficiency scheme for the point of care testing platforms, specifically for non-specialist users (e.g. healthcare workers without laboratory training). 
  4. To develop and qualify a metrological framework underpinning new and innovative methods for early sepsis diagnosis (e.g. transciptomics) and treatment guidance (e.g. metagenomics). This should include an evaluation of their accuracy and reproducibility and the identification of target levels of both, for each method.
  5. To facilitate the take up of the technology and measurement infrastructure developed in the project by the measurement supply chain (Clinical Laboratories, Hospitals), standards developing organisations (ISO/TC 212, CCQM, SoGAT), and end users (e.g. ESCMID, ESICM, IFCC).
Abstract
(Englisch)

As part of this EMPIR project, METAS, for the first time, took part in a European research collaboration project in the field of health and life sciences. The present project was completed at the end of February 2023 after a no-cost extension to recover some of the delays incurred due to the corona pandemic. The present project is considered successful not only because METAS' own metrological capabilities in nucleic acid analysis were significantly improved, but also because further European collaborations have emerged from similar consortia (e.g. GenomeMET) with METAS participation. The septimet project was the first scientific project to utilize equipment purchased for the setup of the nucleic acid metrology laboratory at METAS.

As part of the SEPTIMET project, molecular detection methods for sepsis ("blood poisoning") pathogens were developed and improved and their measurement uncertainty was characterized at their detection and quantification limits. For this purpose, among other things, a marker system for the molecular detection of Neisseria meningitidis was successfully developed in-house. In addition, the measurement uncertainty with regard to the detection and quantification limits of various Neisseria dPCR markers were characterized in detail. In addition to the work originally planned in Septimet, which actually included the study of clinical samples but which could not be collected due to the pandemic, METAS also took part in proficiency tests to detect methicillin-resistant Staphylococcus aureus pathogens. MRSA are known to cause sepsis in humans. As part of METAS' participation, an initial ring trial/interlaboratory comparison involving nucleic acid metrology laboratory (now biological analyses and references) was successfully undertaken for the first time: Results confirmed METAS capabilities. An interlaboratory comparison between LGC, NIB, PTB and METAS was carried out as part of the INSTAND ring test "Bacterial genome detection - MRSA or cMRSA 539". For this, a DNA reference material was developed in the laboratory as an internal control material. This material contains the identical genetic markers as in the Instand comparison material. The externally synthesized DNA was characterized, amplified and purified by sequencing. In this context, a homogenization study was also carried out in order to exclude possible causes of inhibition and to optimize the internal RM development. As part of a SEPTIMET work package meeting (WP3 with METAS participation), NMI partners expressed the desire to publish the results of this interlaboratory comparison in a joint publication. A manuscript (led by the Slovenian NIB and with the participation of PTB and LGC) has not yet been prepared. As a further METAS deliverable, a draft for a Point-of-care Testing (POCT) guidance document was completed. This guidance document is intended to be a recommendation for the implementation of improved traceability and accelerated sepsis pathogen detection in MRSA diagnostics, but must be revised before possible publication.

Umsetzung und Anwendungen
(Englisch)

Results collected as part of the INSTAND interlaboratory comparison shall be published in a joint scientific paper. This publication effort will be lead by NIB (Slovenia). The time frame for this is not known at the time of reporting. The experiences gained in the laboratory with Neisseria dPCR marker development, including the calculation of measurement uncertainties, will continue to be used in the laboratory and form the statistical basis for estimating the measurement uncertainty in molecular marker systems for digital PCR.