Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU

Miller, Russell R.; Lopansri, Bert K.; Burke, John P.; Levy, Mitchell M.; Opal, Steven M.; Rothman, Richard E.; D’Alessio, Franco R.; Sidhaye, Venkataramana K.; Aggarwal, Neil R.; Balk, R.A.; Greenberg, Jared A.; Yoder, Mark; Patel, Gourang; Gilbert, Emily; Afshar, Majid; Parada, Jorge P.; Martin, Greg S.; Esper, Annette; Kempker, Jordan A.; Narasimhan, Mangala; Tsegaye, Adey; Hahn, Stella; Mayo, Paul H.; Poll, Tom van der; Schultz, Marcus J.; Scicluna, Brendon P.; Klouwenberg, Peter Klein; Rapisarda, Antony; Seldon, Therese; McHugh, Leo; Yager, Thomas D.; Cermelli, Silvia; Sampson, Dayle; Rothwell, Victoria; Newman, Richard; Bhide, S.; Fox, Brian; Kirk, James T.; Navalkar, Krupa; Davis, Roy F.; Brandon, Roslyn A.; Brandon, Richard B.

doi:10.1164/rccm.201712-2472oc

Cited by 98 publications

(94 citation statements)

References 32 publications

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“…In a multicohort discovery and validation study in ICU patients, SeptiCyte Lab showed significantly higher diagnostic accuracy for discriminating sepsis from SIRS than did procalcitonin (42). A recent multicohort trial of SeptiCyte Lab sponsored by its manufacturer in 447 ICU patients showed area under the receiver operating characteristic (ROC) curve (AUC) for discriminating sepsis from SIRS ranging from 0.82 to 0.89, with negative predictive values ranging from 89% to 94% (43). It showed a head-to-head AUC of 0.85 for SeptiCyte Lab versus 0.80 for procalcitonin in patients with both measurements.…”

Section: Transcriptomics In the Diagnosis Of Infectionsmentioning

confidence: 99%

Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges

Gunsolus

Sweeney²,

Liesenfeld³

et al. 2019

J Clin Microbiol

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Sepsis is a major source of mortality and morbidity globally. Accurately diagnosing sepsis remains challenging due to the heterogeneous nature of the disease, and delays in diagnosis and intervention contribute to high mortality rates. Measuring the host response to infection enables more rapid diagnosis of sepsis than is possible through direct detection of the causative pathogen, and recent advances in host response diagnostics and prognostics hold promise for improving outcomes. The current review discusses recent advances in the technologies used to probe the host response to infection, particularly those based on transcriptomics. These are discussed in the context of contemporary approaches to diagnosing and prognosing sepsis, and recommendations are made for successful development and validation of host response technologies.

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Section: Transcriptomics In the Diagnosis Of Infectionsmentioning

confidence: 99%

Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges

Gunsolus

Sweeney²,

Liesenfeld³

et al. 2019

J Clin Microbiol

View full text Add to dashboard Cite

show abstract

“…Therefore, given the wide variety of pathogens that can cause disease, clinical microbiology laboratories could benefit from using the approach of "sepsis diagnostic panels" that combine detection of pathogens and key aspects of the patient's innate and systemic immune response. One novel approach is the Immunexpress SeptiCyte LAB assay, which produces a 4-gene expression bloodbased signature and discriminates viral and nonviral causes of systemic inflammation (35). Full review of this approach is beyond the scope of this review.…”

Section: Rapid Molecular Methods For the Diagnosis Of Sepsis And Bactmentioning

confidence: 99%

Rapid Diagnostics for Blood Cultures: Supporting Decisions for Antimicrobial Therapy and Value-Based Care

Wolk

Johnson

2019

The Journal of Applied Laboratory Medicine

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Bacteremia and sepsis are critically important syndromes with high mortality, morbidity, and associated costs. Bloodstream infections and sepsis are among the top causes of mortality in the US, with >600 deaths each day. Most septic patients can be found in emergency medicine departments or critical care units, settings in which rapid administration of targeted antibiotic therapy can reduce mortality. Unfortunately, routine blood cultures are not rapid enough to aid in the decision of therapeutic intervention at the onset of bacteremia. As a result, empiric, broad-spectrum treatment is common-a costly approach that may fail to target the correct microbe effectively, may inadvertently harm patients via antimicrobial toxicity, and may contribute to the evolution of drug-resistant microbes. To overcome these challenges, laboratorians must understand the complexity of diagnosing and treating septic patients, focus on creating algorithms that rapidly support decisions for targeted antibiotic therapy, and synergize with existing emergency department and critical care clinical practices put forth in the Surviving Sepsis Guidelines. IMPACT STATEMENTPatients infected with bacteria in their bloodstream can benefit from deployment of laboratory technology that is more rapid and more accurate than historical methods. This review will characterize the current and novel laboratory technology and the potential effect of technology to improve care for patients with blood stream infections. The review provides a snapshot of emerging technologies for laboratorians to consider as they strategize about how best to support quality initiatives focusing on sepsis in their organizations.

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“…Combined analysis of leukocyte biomarkers has also been investigated. Finally, proteomics and transcriptomics have also been proposed to allow discrimination between bacterial and viral infection (Oved et al , ; Miller et al , ).…”

Section: Sepsis: a New Who Global Health Prioritymentioning

confidence: 99%

Sepsis therapies: learning from 30 years of failure of translational research to propose new leads

2020

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Sepsis has been identified by the World Health Organization (WHO) as a global health priority. There has been a tremendous effort to decipher underlying mechanisms responsible for organ failure and death, and to develop new treatments. Despite saving thousands of animals over the last three decades in multiple preclinical studies, no new effective drug has emerged that has clearly improved patient outcomes. In the present review, we analyze the reasons for this failure, focusing on the inclusion of inappropriate patients and the use of irrelevant animal models. We advocate against repeating the same mistakes and propose changes to the research paradigm. We discuss the long‐term consequences of surviving sepsis and, finally, list some putative approaches—both old and new—that could help save lives and improve survivorship.

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Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU

Abstract: SeptiCyte LAB appears to be a promising diagnostic tool to complement physician assessment of infection likelihood in critically ill adult patients with systemic inflammation. Clinical trial registered with www.clinicaltrials.gov (NCT01905033 and NCT02127502).

Cited by 98 publications

References 32 publications

Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges

Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges

Rapid Diagnostics for Blood Cultures: Supporting Decisions for Antimicrobial Therapy and Value-Based Care

Sepsis therapies: learning from 30 years of failure of translational research to propose new leads

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