Immunexpress and University Hospitals Cleveland Medical Center Present Quality Improvement Feasibility with SeptiCyte® RAPID at the 2023 American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo
“The early accurate diagnosis of sepsis can be challenging, but recent advancements in FDA-cleared lab tests have introduced new tools that may enhance earlier diagnosis.”
Layla Sankari, Hallie H Dolin, Rana Hejal, Habib I Mohammad, Anne Windau, Christina Greig, Deepali R Savadekar, Casey M Weisenberger, Kenneth Remy, Frank Jacono, and Xiaochun S Zhang. University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH
“A combination of SeptiCyte RAPID with NEWS2 may assist clinicians in rapidly and accurately identifying and assessing risk of poor outcomes in acutely ill patients with Sepsis.”
Dr. Richard Brandon, Dr. Krupa A. Navalkar, Dr. Thomas D. Yager, Dr. Silvia Cermelli, Dr. Roy F. Davis
“For patients initially classified as indeterminate and then reassessed by a forced diagnosis, SeptiCyte® RAPID significantly differentiated between SIRS and sepsis.”
E. Hassan, P. Meijer, R. Davis, S. Cermelli and R. Balk
1. In this study, a large percentage of patients initially suspected of sepsis were retrospectively determined to not have sepsis.
2. SeptiCyte® RAPID used alone outperformed other rapid and easily measured markers of sepsis.
3. SeptiCyte® RAPID should be used early in the diagnostic pathway for patients suspected of sepsis to determine likelihood of sepsis. qSOFA, should be used to determine likelihood of poor outcome once a sepsis likelihood has been determined.
4. Rapid and early identification of patients with sepsis using SeptiCyte® RAPID can lead to better management of patients suspected of sepsis.
Dr. Silvia Cermelli, Dr. Krupa A. Navalkar, Dr. Roy F. Davis, Dr. Richard Brandon, Dr. Thomas D. Yager, Dr. Robert Balk
“The results of this study confirm the equivalence of PAXgene® and EDTA blood sample types in the clinical setting when processed with the SeptiCyte® RAPID CE-IVD cartridge. Combined with the small 240 µL blood volume requirement and the convenient and long storage conditions, the addition of the widely used EDTA blood tube as a validated sample type has the potential to greatly expand the clinical utility of this new near patient sepsis diagnostic”
Parcina M, Vasse M, Hannet I, Kirk J. Multi-site validation of EDTA blood as a sample type for SeptiCyte® RAPID CE-IVD, a near-patient diagnostic test for sepsis on the Biocartis Idylla™ System. Association for Molecular Pathology 2022 Annual Meeting Abstracts. J Mol Diagn 2022, 24:S1 Abstract G001
“SeptiCyte® RAPID has been shown to out perform other tools for suspected sepsis including lactate and PCT, providing an earlier and more accurate sepsis diagnosis. This fast and accurate sepsis diagnosis improves patient outcomes.”
“SeptiCyte® RAPID can be processed using EDTA blood samples. The assay can distinguish COVID-19 cases with Severe or Critical presentation on CT from those with Mild or Moderate presentation.”
“SeptiCyte® RAPID proved superior to routinely used diagnostic tools for the differentiation of sepsis from infection negative systemic inflammation”
Hassan E, Davis R, Sampson D, et al. Open Forum Infectious Diseases, Volume 8, Issue Supplement_1, November 2021, S588.
“Diagnostic performance demonstrated that SeptiCyte® RAPID discriminated critical/severe COVID-19 cases from moderate/mild cases.”
M Hardy-Werbin et al ESMID e-library
“A study showing the performance of SeptiCyte RAPID in patients with malignancies and/or on anti-neoplastic or corticosteroid therapies”
Davis R, Navalkar K, van der Poll T, et al. Critical Care Medicine 2021;49(1):643
“SeptiCyte® RAPID test is a rapid, repeatable, reproducible, near-patient, immune-response sepsis diagnostic, providing accurate results in ~ 1 hr to differentiate sepsis from SIRS”
Cermelli S, Heath K, Kauleers I. et al. The Journal of Molecular Diagnostics 2020;22(11)S26.
“SeptiCyte® RAPID differentiated patients with candidemia from those with INSI/SIRS, not infected and healthy subjects”
Sampson D, Bulter J, Sengers H. The Journal of Molecular Diagnostics 2020;22(11)S29
“First demonstration of a validated, fully-integrated, rapid, repeatable, reproducible, near-patient, immune-response sepsis diagnostic”
“Preliminary diagnostic characteristics of SeptiCyte® RAPID test in differentiating sepsis from SIRS”
J Kirk et al Critical Care 2020 24 (Suppl 1): 87
“The SeptiCyte® signature has broad diagnostic utility in heterogenous sepsis patient population”
K Navaler et al Critical Care 2020 24 (Suppl 1): 87
“First quantification of uncertainty in sepsis diagnosis at admission, discharge and over the patient stay in a matched cohort”
“FDA-clearance study of the first gene signature assay for sepsis”
“SeptiCyte® technology provides actionable results to aid early recognition and treatment of sepsis patients, independently of the presence of the causative pathogen”
“Pilot validation of the SeptiCyte® technology among critically ill children”
Zimmerman J, Sullivan E, Sampson D, et al. Critical Care Medicine 2015;43(12):258.