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  • Sepsis is a major global health priority1
    • 48.9 million annual sepsis cases worldwide
    • 11.0 million annual deaths
  • Leading cause of ICU deaths
  • Early identification of sepsis is fundamental to impact morbidity and mortality2


Evaluate the use of Lactate, PCT or SeptiScore® either alone or in combination, in differentiating sepsis from infection negative systematic inflammation (INSI).


  • 447 previously prospectively evaluated adult ICU patients (8 sites)5
  • 3 Inclusion Criteria:
  • 2 or more signs of:
    • Temperature > 38C or <36C
    • Heart rate > 90 beats/minute
    • Tachypnea > 20 breaths/minute
    • White blood cell count >12,000 cells/ mm3 or <4000 cells/mm3 or > 10% immature neutrophils
  • Therapeutic antibiotic administration
  • Lactate, PCT and SeptiCyte® RAPID samples obtained within 24 hours of ICU admission
  • 3 physician panel retrospectively reviewed and categorized each patient as Sepsis or INSI. To be acceptable, at least 2 physicians had to agree on the same diagnosis.
  • Area under the receiver operating curve (AUROC) with 95% confidence intervals via generalized linear models for each parameter alone and all combinations
  • AUROC for discrimination between sepsis and infection negative-infectious systemic inflammation via paired t-test.


• 222 patients included (Sepsis 113; INSI 109)
• Patient Demographics

• Outcomes


1. SeptiScore®, alone or in any combination with lactate or PCT, proved superior in its ability to differentiate sepsis from INSI

2. PCT increases with inflammation but provides a less precise differentiator between sepsis and INSI due to overlapping and wide distribution of data

3. Lactate is sub-optimal in its ability to differentiate sepsis from INSI

4. Future evaluations should address the role of the SeptiScore® in the clinical assessment of patients with suspected sepsis to determine the impact on early detection, treatment and outcomes of sepsis.


Erkan Hassan, Pharm.D.,FCCM* , Roy Davis, M.D. Ph.D† , Dayle Sampson, Ph.D.† , Russell Miller, III, M.D., M.P.H., FCCM‡ , on behalf of the MARS & VENUS Study Investigators *

Consultant Immunepxress, Inc. Baltimore, MD† / Immunexpress, Inc, Seattle, WA‡ / FirstHealth of the Carolinas, Pinehurst, N.C.*


1. Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: Analysis for the Global Burden of Disease Study. Lancet 2020;395:200-211.

2. Martin-Loeches I, Levy MM, Artigas A. Management of severe sepsis: Advances, challenges, and current status. Drug Design, Development and Therapy 2015;9:2079-2088.

3. Hernandez G, Ospina-Tascon GA, Damiani LP. Effect of resuscitation strategy targeting peripheral perfusion status vs serum lactate levels on 28 day mortality among patients with septic shock. The ANDROMEDA-SHOCK Randomized controlled trial. JAMA 2019;321(17):654-664.

4. Paudel R, Dogra P, Montgomery-Yates AA, et al. Procalcitonin: A promising tool or just another overhyped test? Int J Med Sci 2020;17(3):332-337.

5. Miller RR, Lopansri BK, Burke JP, et al. Validation of a host response assay, SeptiCyte® LAB, for discriminating sepsis from systemic inflammatory response syndrome in the ICU. Am J Respir Crit Care Med 2018;198(7):903-913.


The investigator partners, clinical study coordinators, laboratory technical staff and participants in the VENUS/VENUS supplement clinical trials