Secondary Logo

Journal Logo

Institutional members access full text with Ovid®

Validation of a Novel Molecular Host Response Assay to Diagnose Infection in Hospitalized Patients Admitted to the ICU With Acute Respiratory Failure

Koster-Brouwer, Maria E. MSc1,2; Verboom, Diana M. MD1,2; Scicluna, Brendon P. PhD3; van de Groep, Kirsten MD1,2; Frencken, Jos F. MD1,2; Janssen, Davy4; Schuurman, Rob PhD4; Schultz, Marcus J. MD, PhD5; van der Poll, Tom MD, PhD3,6; Bonten, Marc J.M. MD, PhD1,4; Cremer, Olaf L. MD, PhD2; ; on behalf of the MARS Consortium

doi: 10.1097/CCM.0000000000002735
Clinical Investigations
Buy
SDC

Objectives: Discrimination between infectious and noninfectious causes of acute respiratory failure is difficult in patients admitted to the ICU after a period of hospitalization. Using a novel biomarker test (SeptiCyte LAB), we aimed to distinguish between infection and inflammation in this population.

Design: Nested cohort study.

Setting: Two tertiary mixed ICUs in the Netherlands.

Patients: Hospitalized patients with acute respiratory failure requiring mechanical ventilation upon ICU admission from 2011 to 2013. Patients having an established infection diagnosis or an evidently noninfectious reason for intubation were excluded.

Interventions: None.

Measurement and Main Results: Blood samples were collected upon ICU admission. Test results were categorized into four probability bands (higher bands indicating higher infection probability) and compared with the infection plausibility as rated by post hoc assessment using strict definitions. Of 467 included patients, 373 (80%) were treated for a suspected infection at admission. Infection plausibility was classified as ruled out, undetermined, or confirmed in 135 (29%), 135 (29%), and 197 (42%) patients, respectively. Test results correlated with infection plausibility (Spearman’s rho 0.332; p < 0.001). After exclusion of undetermined cases, positive predictive values were 29%, 54%, and 76% for probability bands 2, 3, and 4, respectively, whereas the negative predictive value for band 1 was 76%. Diagnostic discrimination of SeptiCyte LAB and C-reactive protein was similar (p = 0.919).

Conclusions: Among hospitalized patients admitted to the ICU with clinical uncertainty regarding the etiology of acute respiratory failure, the diagnostic value of SeptiCyte LAB was limited.

1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.

2Department of Intensive Care Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.

3Center of Experimental and Molecular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

4Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands.

5Department of Intensive Care Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

6Division of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Supported, in part, by the Center for Translation Molecular Medicine (http://www.ctmm.nl), project MARS (grant 041-201). We received SeptiCyte LAB kits and technical assistance from Immunexpress. Neither the sponsor nor Immunexpress played a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; or the decision to submit the article for publication.

The University Medical Center Utrecht received funding from Immunexpress. Furthermore, Immunexpress provided SeptiCyte LAB kits and technical assistance in kind. The Academic Medical Center Amsterdam and the University Medical Center Utrecht received funding from the Center for Translational and Molecular Medicine, project MARS.

The authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: M.E.Brouwer-6@umcutrecht.nl

Copyright © 2018 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.