Sepsis Test Demonstrates Clinical Utility in Critically Ill Heterogeneous Patient Populations

Sepsis is the primary cause of death in hospitals, resulting in more fatalities than any other condition due to its rapid onset and the challenges associated with early detection. If not identified or treated promptly, sepsis can lead to tissue damage, organ failure, permanent disability, and often death. Physicians around the world face difficulties in quickly and reliably diagnosing sepsis due to inadequate diagnostic tools. A patient's pre-existing medical conditions can influence the body's immune response to infection as well as the clinical parameters utilized for diagnosing sepsis. The effectiveness of a diagnostic test for sepsis relies on its capability to distinguish between sepsis and systemic inflammatory response syndrome (SIRS) in various critically ill patient populations, including immunocompromised individuals and those with cancer. Now, a sample-to-answer, cartridge-based host response molecular test for sepsis has shown consistent performance in differentiating sepsis from SIRS, regardless of demographics or the presence of medical conditions.

Immunexpress’ (Seattle, WA, USA) SeptiCyte RAPID is a sample-to-answer, cartridge-based host response molecular test for sepsis that utilizes reverse transcription polymerase chain reaction (RT-PCR) to quantify the relative expression levels of host response genes extracted from whole blood. SeptiCyte RAPID is designed to be used alongside clinical assessments, vital signs, and laboratory findings to help differentiate infection-positive (sepsis) from infection-negative SIRS in patients exhibiting escalating signs and symptoms of critical illness. The test generates a score (SeptiScore) that categorizes results into four distinct interpretation bands based on the increasing likelihood of sepsis. SeptiCyte RAPID is intended for in-vitro diagnostic use and operates on the Biocartis Idylla Platform.

In a study published in the Journal of Clinical Medicine, SeptiCyte RAPID demonstrated its ability to effectively differentiate between sepsis and SIRS across various races, differing medical conditions, treatment regimens, and sources of infection, as well as classify patients into distinct phenotypes based on clinical severity. Identifying the phenotypes of complex sepsis patients is crucial for determining the most appropriate and individualized treatments. The study demonstrated that the performance of SeptiCyte RAPID remained largely unaffected by key variables associated with patient heterogeneity, including differences among racial groups and underlying disease states. The test successfully identified septic shock in both Black and White patients.

No significant performance differences were observed based on the presence or absence of conditions such as hyperglycemia, impaired immunity, hypertension, cardiovascular disease, kidney disease, cancer, or obesity. Using unsupervised learning methods, two to three distinct patient subgroups were identified among those with sepsis. One subgroup was primarily composed of patients displaying more severe sepsis, including septic shock. The study found two to three distinct patient subgroups within the entire cohort of sepsis or SIRS patients. SeptiCyte RAPID consistently demonstrated strong performance across subgroups in both sepsis and SIRS patients. SeptiCyte RAPID is CE Marked as a near-patient sample-to-answer test in European Union (EU) member countries and those aligned with the EU IVD Directive (98/79/EC). As of November 2021, SeptiCyte RAPID has also received FDA clearance for use in hospitalized patients suspected of having sepsis.

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