18HLT03 SEPTIMET: Metrology to enable rapid and accurate clinical measurements in acute management of sepsis

• Research unit: METAS
• Project number: F-1040.30114

Key words (English)

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

Short description (English)

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.

Project aims (English)

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).