Stratification of COVID-19 severity using SeptiCyte RAPID, a novel host immune response test

Abstract

SeptiCyte RAPID is a gene expression assay measuring the relative expression levels of host response genes PLA2G7 and PLAC8, indicative of a dysregulated immune response during sepsis. As severe forms of COVID-19 may be considered viral sepsis, we evaluated SeptiCyte RAPID in a series of 94 patients admitted to Foch Hospital (Suresnes, France) with proven SARS-CoV-2 infection. EDTA blood was collected in the emergency department (ED) in 67 cases, in the intensive care unit (ICU) in 23 cases and in conventional units in 4 cases. SeptiScore (0-15 scale) increased with COVID-19 severity. Patients in ICU had the highest SeptiScores, producing values comparable to 8 patients with culture-confirmed bacterial sepsis. Receiver operating characteristic (ROC) curve analysis had an area under the curve (AUC) of 0.81 for discriminating patients requiring ICU admission from patients who were immediately discharged or from patients requiring hospitalization in conventional units. SeptiScores increased with the extent of the lung injury. For 68 patients, a chest computed tomography (CT) scan was performed within 24 hours of COVID-19 diagnosis. SeptiScore > 7 suggested lung injury ≥ 50 % (AUC = 0.86). SeptiCyte RAPID was compared to other biomarkers for discriminating Critical + Severe COVID-19 in ICU, versus Moderate + Mild COVID-19 not in ICU. The mean AUC for SeptiCyte RAPID was superior to that of any individual biomarker or combination thereof. In contrast to C-reactive protein (CRP), correlation of SeptiScore with lung injury was not impacted by treatment with anti-inflammatory agents. SeptiCyte RAPID can be a useful tool to identify patients with severe forms of COVID-19 in ED, as well as during follow-up.

Competing Interest Statement

TDY, KN, JTK are current or former employees and shareholders in Immunexpress. The other authors declare no competing interests.

Funding Statement

This study has been supported in part by contract # 75A50120C00125 from the DRIVe Solving Sepsis program of the Biomedical Advanced Research and Development Authority (BARDA), part of the US HHS Office of the Assistant Secretary for Preparedness and Response.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was conducted under a blanket protocol for COVID-related research at the Foch Hospital (Information reutilisation des donnees personnelles et des echantillons biologiques a des fins de recherche V2 - 9 avril 2020), which had been established and approved by the local ethics committee of the Foch Hospital (IRB00012437). The study was performed in agreement with French ethical laws, such that the patients and their families were informed that their biological samples and data used for routine care could be used in an anonymous manner unless they expressed their opposition. No patients enrolled in this study, or their families, expressed opposition to the use of their biological samples and data, which according to the French ethical laws and Foch Hospital ethics committee constitutes informed consent.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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Data Availability

All data produced in the present study are available upon reasonable request to the authors

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