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https://www.um.edu.mt/library/oar/handle/123456789/97537| Title: | Validation of a host response assay, septicyte LAB, for discriminating sepsis from systemic inflammatory response syndrome in the ICU |
| Authors: | Miller 3rd, Russell R. Lopansri, Bert K. Burke, John P. Levy, Mitchell Opal, Steven Rothman, Richard E. D'Alessio, Franco R. Sidhaye, Venkataramana K. Aggarwal, Neil R. Balk, Robert Greenberg, Jared A. Yoder, Mark Patel, Gourang Gilbert, Emily Afshar, Majid Parada, Jorge P. Martin, Greg S. Esper, Annette M. Kempker, Jordan A. Narasimhan, Mangala Tsegaye, Adey Hahn, Stella Mayo, Paul Poll, Tom van der Schultz, Marcus J. Scicluna, Brendon P. Klein Klouwenberg, Peter M.C. Rapisarda, Antony Seldon, Therese A. McHugh, Leo C. Yager, Thomas D. Cermelli, Silvia Sampson, Dayle Rothwell, Victoria Newman, Richard Bhide, Shruti Fox, Brian A. Kirk, James T. Navalkar, Krupa Davis, Roy F. Brandon, Roslyn A. Brandon, Richard B. |
| Keywords: | Infection -- Immunological aspects Inflammation -- Immunological aspects Septicemia -- Diagnosis |
| Issue Date: | 2018 |
| Publisher: | American Thoracic Society |
| Citation: | Miller III, R. R., Lopansri, B. K., Burke, J. P., Levy, M., Opal, S., Rothman, R. E., ... & Brandon, R. B. (2018). Validation of a host response assay, SeptiCyte LAB, for discriminating sepsis from systemic inflammatory response syndrome in the ICU. American Journal of Respiratory and Critical Care Medicine, 198(7), 903-913. |
| Abstract: | Rationale: A molecular test to distinguish between sepsis and systemic inflammation of noninfectious 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 noninfectious systemic inflammation in critically ill adults. Methods: The study employed a prospective, observational, noninterventional design and recruited a heterogeneous cohort of adult critical care patients from seven sites in the United States (n = 249). An additional group of 198 patients, recruited in the large MARS (Molecular Diagnosis and Risk Stratification of Sepsis) consortium trial in the Netherlands ( www.clinicaltrials.gov identifier NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. The performance of SeptiCyte LAB was compared with 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 the curve of 0.82-0.89 for discriminating sepsis from noninfectious systemic inflammation. The relative likelihood of sepsis versus noninfectious 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. The 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 registered with www.clinicaltrials.gov (NCT01905033 and NCT02127502). |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/97537 |
| Appears in Collections: | Scholarly Works - FacHScABS |
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| Validation_of_a_host_response_assay_septicyte_LAB_for_discriminating_sepsis_from_systemic_inflammatory_response_syndrome_in_the_ICU.pdf Restricted Access | 901.15 kB | Adobe PDF | View/Open Request a copy |
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