Validation of a Host Response Assay, Septicyte LAB, for Discriminating Sepsis from SIRS in the ICU Journal Article

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Authors: Miller Iii, R. R.; Lopansri, B. K.; Burke, J. P.; Levy, M; Opal, S; Rothman, R. E.; D'Alessio, F. R.; Sidhaye, V. K.; Aggarwal, N. R.; Balk, R; Greenberg, J. A.; Yoder, M; Patel, G.; Gilbert, E; Afshar, M; Parada, J. P.; Martin, G. S.; Esper, A. M.; Kempker, J. A.; Narasimhan, M; Tsegaye, A; Hahn, S; Mayo, P; van der Poll, T.; Schultz, M. J.; Scicluna, B. P.; Klein Klouwenberg, P.; Rapisarda, A; Seldon, T. A.; McHugh, L. C.; Yager, T. D.; Cermelli, S.; Sampson, D; Rothwell, V.; Newman, R.; Bhide, S.; Kirk, J. T.; Navalkar, K.; Davis, R. F.; Brandon, R. A.; Brandon, R. B.
Article Title: Validation of a Host Response Assay, Septicyte LAB, for Discriminating Sepsis from SIRS in the ICU
Abstract: RATIONALE: A molecular test to distinguish between sepsis and systemic inflammation of non-infectious etiology could potentially have clinical utility. OBJECTIVES: This study evaluated the diagnostic performance of a molecular host response assay (SeptiCyte LAB) designed to distinguish between sepsis and non-infectious systemic inflammation in critically ill adults. METHODS: The study employed a prospective, observational, non-interventional design, and recruited a heterogeneous cohort of adult critical care patients from seven sites in the USA (N=249). An additional group of 198 patients, recruited in the large MARS consortium trial in the Netherlands (clinicaltrials.gov identifier: NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. Performance of SeptiCyte LAB was compared to retrospective physician diagnosis by a panel of three experts. MEASUREMENTS AND MAIN RESULTS: In receiver operating characteristic curve analysis, SeptiCyte LAB had an estimated area under curve of 0.82-0.89 for discriminating sepsis from non-infectious systemic inflammation. The relative likelihood of sepsis versus non-infectious systemic inflammation was found to increase with increasing test score (range 0-10). In a forward logistic regression analysis, the diagnostic performance of the assay was improved only marginally when used in combination with other clinical and laboratory variables including procalcitonin. Performance of the assay was not significantly affected by demographic variables including age, sex, or race/ethnicity. CONCLUSIONS: 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 registrations available at clinicaltrials.gov, IDs NCT02127502 and NCT01905033.
Journal Title: American journal of respiratory and critical care medicine
ISSN: 1535-4970; 1073-449X
Publisher: Unknown  
Journal Place: United States
Date Published: 2018
Language: eng
DOI/URL:

10.1164/rccm.201712-2472OC
Notes: LR: 20180510; ClinicalTrials.gov/NCT01905033; ClinicalTrials.gov/NCT02127502; GR: R01 HL124099/HL/NHLBI NIH HHS/United States; JID: 9421642; OTO: NOTNLM; 2018/04/07 06:00 [pubmed]; 2018/04/07 06:00 [medline]; 2018/04/07 06:00 [entrez]; aheadofprint