Commercial point-of-care devices for Sepsis diagnosis: A scoping review of technologies, diagnostic targets, and clinical evidence

Sepsis is a life-threatening syndrome resulting from a dysregulated host-response to infection, and delays in diagnosis contribute to high mortality and substantial healthcare burdens. Although point-of-care (POC) testing has expanded rapidly, evidence regarding commercial sepsis POC platforms remains fragmented across manufacturers, technologies, diagnostic targets, and study designs. This PRISMA-guided scoping review mapped the landscape of commercially available POC devices used for sepsis assessment, classified platforms by diagnostic technology and target type, and synthesized available analytical, clinical, and regulatory evidence. Web of Science and Scopus were searched from January 1, 2000, to October 28, 2025, using (“Sepsis” OR “Septic”) AND (“Point-of-care” OR “POC”). From 3398 records, 26 eligible studies describing commercial sepsis-related POC devices were included. Optical platforms predominated (77%), followed by electrochemical systems (19.0%), and magnetic resonance approaches (4.0%). Antibody-based biorecognition was most common (73.1%), and inflammatory biomarkers were the primary diagnostic targets (69.3%), particularly procalcitonin and C-reactive protein, whereas fewer platforms targeted pathogen nucleic acids. Turnaround time ranged from seconds to minutes for electrochemical lactate testing, 3–20 min for most immunoassays, 45–65 min for multiplex PCR, and up to 3–5 h for direct pathogen detection. Most devices held CE marking only (61.5%), fewer had both CE marking and FDA clearance (19.2%), and 19.2% lacked documented approvals. Overall, commercial sepsis POC diagnostics are increasingly exploring integrated multiplex and molecular systems; however, published evidence remains dominated by analytical comparisons rather than multicenter clinical effectiveness studies, underscoring the need for standardized reporting and real-world validation.