RT Journal Article SR Electronic T1 Immune Profiling Panel: a proof of concept study of a new multiplex molecular tool to assess the immune status of critically-ill patients JF bioRxiv FD Cold Spring Harbor Laboratory SP 636522 DO 10.1101/636522 A1 Dina M. Tawfik A1 Laurence Vachot A1 Adeline Bocquet A1 Fabienne Venet A1 Thomas Rimmelé A1 Guillaume Monneret A1 Sophie Blein A1 Jesse L. Montogomery A1 Andrew C. Hemmert A1 Alexandre Pachot A1 Virginie Moucadel A1 Javier Yugueros Marcos A1 Karen Brengel-Pesce A1 François Mallet A1 Julien Textoris YR 2019 UL http://biorxiv.org/content/early/2019/05/15/636522.abstract AB Background Critical illness such as sepsis is a life-threatening syndrome defined as a dysregulated host response to infection and is characterized by patients exhibiting various impaired immune profiles. In the field of diagnosis, a gap still remains in identifying the immune profile of critically-ill patients in the ICU. The availability of an immune profiling tool holds a great potential in providing patients at high risk with more accurate and precise management. In this study, a multiplex immune profiling panel prototype was assessed for its ability to semi-quantify immune markers directly from blood, using the FilmArray® System.Results The Immune Profiling Panel (IPP) prototype consists of 16 biomarkers that target both the innate and adaptive immune responses, pro- and anti-inflammatory mediators as well as genes involved in diverse regulatory pathways. The analytical studies carried out on healthy volunteers showed minimal inter- and intra-variability in testing the samples across the tested lots. The majority of the assays were linear with an R2 higher than 0.8. Results from the IPP pouch were comparable to qPCR and were within the limits of agreement. Finally, quantification cycle values of the target genes were normalized against reference genes to account for the different composition of cells among specimens. The use of the selected panel of markers in IPP demonstrated various gene modulations that could distinctly differentiate three profiles: healthy, borderline mHLA-DR septic shock patients and low mHLA-DR septic shock patients.Conclusion The Immune Profiling Panel allowed host transcriptomic analysis of immune response biomarkers directly from whole blood in less than an hour. The use of IPP showed great potential for the development of a fully automated, rapid and easy-to-use immune profiling tool, enabling the stratification of critically-ill patients at high risk in the ICU.IPPImmune Profiling PanelICUIntensive Care UnitmHLA-DRmonocytic Human Leukocyte Antigen-DRCqquantification cycleRTReverse TranscriptionqPCRquantitative polymerase chain reactionRNARiboNucleic AcidSDStandard Deviation