Article originally published August 2025 in Critical Care Explorations
ABSTRACT | Challenges Facing Developers of Diagnostic Tests for Sepsis: A Report From Sepsis Alliance and the IMSCC
The Surviving Sepsis Campaign’s research committee expressed a need for tools to screen for and identify sepsis. Further, antimicrobial stewardship efforts are hampered by an inability to effectively rule out sepsis in patients with signs and symptoms potentially attributable to infection, underscoring a need for diagnostic tests that are both sensitive and specific. However, until recently, no tests specific for the diagnosis of sepsis or prediction of sepsis onset were available, and hospital uptake of such tests remains erratic. Clinicians and diagnostic test developers could benefit from understanding the complexities and obstacles to producing effective sepsis diagnostic tests and devices (DTDs). For clinicians, such knowledge could help them use commercially available DTDs with a better understanding of what the tests can achieve and which clinical decisions are affected, and help them to advise their hospitals on the selection of such tests. This analysis by the Infection Management and Sepsis Collaborative Community (IMSCC) explores and delineates those issues, both to explain the paucity of sepsis DTDs and to inform future developers what issues must be addressed for DTDs to achieve regulatory approval and gain clinical adoption.
Read the full article, co-authored by Prenosis CEO and co-founder, Bobby Reddy, Jr. for Sepsis Alliance and the Infection Management and Sepsis Collaborative Community (IMSCC).