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Article History

Received: 2 April 2026

Accepted: 1 June 2026

First Online: 11 August 2026

Declarations

Conflict of interest: Some authors are employees of, or have received research support from, Loop Diagnostics S.L., StartUB! – University of Barcelona, Spain, the developer of the SeptiLoop® assay evaluated in this study. Loop Diagnostics S.L. is an early-stage academic spin-off originating from the University of Barcelona (StartUB!), with limited commercial activity at the time of the study. The economic model was developed by RTI Health Solutions using prespecified methods and assumptions, funded by the academic grant previously declared. The sponsor provided funding and access to data but had no role in the selection of comparators, model structure, analysis, interpretation of results, or the decision to submit the manuscript for publication. All authors had full access to the model outputs and take responsibility for the integrity and accuracy of the analysis.

Author Contributions: EHJ, QCC, EGJJ, and EPM conceived the study. JL, KZ, CMD, CK contributed to model development and data analysis. All authors contributed to interpretation of the results, drafting and critical revision of the manuscript, and approved the final version.

Acknowledgements: The authors thank RTI Health Solutions for their contribution to the development of the economic model.

Funding: This research was funded by the academic grant Ayudas a Doctorados industriales (DI-2024-00112 & DI-2024-00051), with the support of the Pla de doctorats industrials of the Department of Research and Universities of the Generalitat de Catalunya. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and in the decision to submit the manuscript for publication.

Ethics approval: Not applicable. This study is a modelling analysis based exclusively on published literature and anonymized aggregate data; no primary data collection involving human participants was conducted.

Consent to participate and Consent for publication: Not applicable. No individual patient data, interviews, or identifiable information were used in this analysis.

Code Availability (Availability of Materials and Data): The decision-analytic model was developed in Microsoft Excel. The model structure and key assumptions are described in the manuscript. The full model file is not publicly available but may be shared with academic researchers upon reasonable request, subject to confidentiality agreements. The data supporting the findings of this study are derived from a combination of published sources and aggregated clinical data used as model inputs. All parameter values, assumptions, and data sources are reported in the manuscript tables and references, and supplementary material. Clinical data on file used to inform diagnostic performance parameters are not publicly available due to commercial and confidentiality restrictions but are available from the corresponding author upon reasonable request and subject to data sharing agreements.