| Title: |
Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation |
| Authors: |
Balk, Robert; Esper, Annette M.; Martin, Greg S.; 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.; Greenberg, Jared A.; Yoder, Mark; Patel, Gourang; Gilbert, Emily; Parada, Jorge P.; Afshar, Majid; Kempker, Jordan A.; van der Poll, Tom; Schultz, Marcus J.; Scicluna, Brendon P.; Klein Klouwenberg, Peter M.C.; Liebler, Janice; Blodget, Emily; Kumar, Santhi; Navalkar, Krupa; Yager, Thomas D.; Sampson, Dayle; Kirk, James T.; Cermelli, Silvia; Davis, Roy F.; Brandon, Richard B. |
| Publisher Information: |
MDPI AG |
| Publication Year: |
2024 |
| Collection: |
University of Malta: OAR@UM / L-Università ta' Malta |
| Subject Terms: |
Host-virus relationships; Septicemia -- Diagnosis; Chronic diseases; Inflammation |
| Description: |
(1) Background: SeptiCyte RAPID is a molecular test for discriminating sepsis from non-infectious systemic inflammation, and for estimating sepsis probabilities. The objective of this study was the clinical validation of SeptiCyte RAPID, based on testing retrospectively banked and prospectively collected patient samples. (2) Methods: The cartridge-based SeptiCyte RAPID test accepts a PAXgene blood RNA sample and provides sample-to-answer processing in ~1 h. The test output (SeptiScore, range 0-15) falls into four interpretation bands, with higher scores indicating higher probabilities of sepsis. Retrospective (N = 356) and prospective (N = 63) samples were tested from adult patients in ICU who either had the systemic inflammatory response syndrome (SIRS), or were suspected of having/diagnosed with sepsis. Patients were clinically evaluated by a panel of three expert physicians blinded to the SeptiCyte test results. Results were interpreted under either the Sepsis-2 or Sepsis-3 framework. (3) Results: Under the Sepsis-2 framework, SeptiCyte RAPID performance for the combined retrospective and prospective cohorts had Areas Under the ROC Curve (AUCs) ranging from 0.82 to 0.85, a negative predictive value of 0.91 (sensitivity 0.94) for SeptiScore Band 1 (score range 0.1-5.0; lowest risk of sepsis), and a positive predictive value of 0.81 (specificity 0.90) for SeptiScore Band 4 (score range 7.4-15; highest risk of sepsis). Performance estimates for the prospective cohort ranged from AUC 0.86-0.95. For physician-adjudicated sepsis cases that were blood culture (+) or blood, urine culture (+)(+), 43/48 (90%) of SeptiCyte scores fell in Bands 3 or 4. In multivariable analysis with up to 14 additional clinical variables, SeptiScore was the most important variable for sepsis diagnosis. A comparable performance was obtained for the majority of patients reanalyzed under the Sepsis-3 definition, although a subgroup of 16 patients was identified that was called septic under Sepsis-2 but not under Sepsis-3. (4) Conclusions: ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://www.um.edu.mt/library/oar/handle/123456789/129405 |
| DOI: |
10.3390/jcm13051194 |
| Availability: |
https://www.um.edu.mt/library/oar/handle/123456789/129405; https://doi.org/10.3390/jcm13051194 |
| Rights: |
info:eu-repo/semantics/openAccess ; The copyright of this work belongs to the author(s)/publisher. The rights of this work are as defined by the appropriate Copyright Legislation or as modified by any successive legislation. Users may access this work and can make use of the information contained in accordance with the Copyright Legislation provided that the author must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the prior permission of the copyright holder |
| Accession Number: |
edsbas.49080AE9 |
| Database: |
BASE |