Erika P. Plata-Menchaca

From sepsis biomarker discovery to regulated in vitro diagnostics: evidence, certification status and implementation gaps

The Mini Review examines selected sepsis biomarkers and diagnostic platforms with emphasis on technologies that have reached certified or cleared IVD implementation, or that illustrate a credible route toward regulated use, set against an evolving regulatory landscape shaped by the EU IVDR and the phased rollout of EUD...