Profile of the SeptiCyte™ LAB gene expression assay to diagnose infection in critically ill patients
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Publication date
2019-02
Authors
Verboom, Diana M
Koster-Brouwer, Maria E.
Varkila, Meri R J
Bonten, Marc
Cremer, Olaf L
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Document Type
Article
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taverne
Abstract
Sepsis is a severe and frequently occurring clinical syndrome, caused by the inflammatory response to infections. Recent studies on the human transcriptome during sepsis have yielded several gene-expression assays that might assist physicians during clinical assessment of patients suspected of sepsis. SeptiCyte™ LAB (Immunexpress, Seattle, WA) is the first gene expression assay that was cleared by the FDA in the United States to distinguish infectious from non-infectious causes of systemic inflammation in critically ill patients. The test consists of the simultaneous amplification of four RNA transcripts (CEACAM4, LAMP1, PLAC8, and PLA2G7) in whole blood using a quantitative real time PCR reaction. This review provides an overview of the challenges in the diagnosis of sepsis, the development of gene expression signatures, and a detailed description of available clinical performance studies evaluating SeptiCyte™ LAB.
Keywords
SeptiCyte™ LAB, biomarkers, diagnosis, gene expression assay, infection, sepsis, Humans, Transcriptome, Critical Illness, Gene Expression Profiling/instrumentation, Sepsis/diagnosis, SeptiCyte (TM) LAB, Taverne, Genetics, Molecular Medicine, Molecular Biology, Pathology and Forensic Medicine, Journal Article, Review, Research Support, Non-U.S. Gov't
Citation
Verboom, D M, Koster-Brouwer, M E, Varkila, M, Bonten, M & Cremer, O L 2019, 'Profile of the SeptiCyte™ LAB gene expression assay to diagnose infection in critically ill patients', Expert Review of Molecular Diagnostics, vol. 19, no. 2, pp. 95-108. https://doi.org/10.1080/14737159.2019.1567333