Diagnose Sepsis with more certainty in just one hour with SeptiCyte® RAPID

Last updated: 12th May, 2021

Products are for professional/laboratory use.  SeptiCyte® RAPID revolutionizes sepsis diagnosis and treatment, with actionable results available in an hour. SeptiCyte® RAPID can determine the likelihood of sepsis and differentiate from non-infectious systemic inflammatory response syndrome (SIRS) in critically ill patients. The test, which uses a small volume of blood, can be performed easily in any hospital lab with the Biocartis Idylla™ molecular testing system.

Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, is one of the main causes of morbidity and mortality in critically ill patients. There remains a high unmet need for a rapid, sensitive, reliable diagnostic test to provide physicians with actionable results to rule out sepsis with high confidence or expedite preventative action with prompt therapeutic intervention for a potential life-threatening situation. SeptiCyte® RAPID seeks to address this unmet clinical challenge.

Clinical validation
Clinical research results published in peer reviewed medical journals have demonstrated the accuracy of SeptiCyte® technology in both adults and children suspected of sepsis1-5. Clinical observations and in silico analyses have shown SeptiCyte® RAPID can discriminate sepsis from SIRS across a heterogeneous patient population, including those with immunosuppression.

Actionable results in 1 hour
SeptiCyte® RAPID performance is independent of illness severity, superior to other clinical variables in discriminating SIRS/sepsis1. SeptiCyte® RAPID can recognize the host immune response to bacterial, viral or fungal pathogens causing sepsis and provide the physician with highly accurate and actionable results in 1 hour.

Improve outcome, lower costs
Studies have revealed higher costs and mortality are associated with a delayed sepsis diagnosis6. So an early accurate sepsis rule in/rule out using SeptiCyte® RAPID can efficiently improve patient outcomes. Furthermore, it can relieve financial burdens. An economic study7 indicated an average ICU in the US could save ~ $5M/year adopting SeptiCyte® LAB.

Expedite and optimize clinical workflow
With high accuracy, SeptiCyte® RAPID can strengthen clinical decision making either enabling early sepsis protocol implementation, if there is a high SeptiScore® (high PPV) or re-evaluating etiology of symptoms if there is a low SeptiScore® (high NPV), both of which improve patient management and antibiotic stewardship.

*SeptiCyte® RAPID is available for IVD use in New Zealand and RUO use in Australia.

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1. Miller R, Lopansri B, McHugh L, Rapisarda A, Seldon T, Burke J. 2015. Validation of a novel host response assay to distinguish SIRS and sepsis in critically ill patients. Am. J Respir Crit Care Med . 2018 Oct 1;
2. D.M. Verboom, M.E. Koster-Brouwer, J.P. Ruurda, et al., A high-risk gastro-intestinal surgery, Journal of Critical Care, https://doi.org/10.1016/j.jcrc.2019.07.020.
3. Zimmerman JJ, Sullivan E, Yager TD, et al: Diagnostic accuracy of a host gene expression signature that discriminates clinical severe sepsis syndrome and infection-negative systemic inflammation among critically ill children. Crit Care Med 2017; 45:e418–e425.
4. Koster-Brouwer ME, Verboom DM, Scicluna BP, Van De Groep K, Frencken JF, Janssen D, et al. Validation of a novel molecular host response assay to diagnose infection in hospitalized patients admitted to the ICU with acute respiratory failure. Crit Care Med 2018;46(3):368–74.
5. R Brandon, J Kirk, T Yager, S Cermelli, R Davis, D Sampson, P Sillekens, I Keuleers, T Vanhoey. Clinical performance of a rapid sepsis test on a near-patient molecular testing platform. # P481 ISICEM 2020, Brussels
6. Paoli CJ et al., Epidemiology and Costs of Sepsis in the United States-An Analysis Based on Timing of Diagnosis and Severity Level. Crit Care Med 2018:1889-1897.
7. McHugh L. Modeling improved patient management and hospital savings with SeptiCyte® LAB in the diagnosis of sepsis at ICU admission. Open Forum Infectious Disease 2018;5 (suppl 1):s589, #2022.

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