Molecular Laboratory Test Can Discriminate Sepsis From Noninfectious SIRS

The use of Septicyte^TM LAB (Immunexpress; Seattle, Washington) may serve as an effective complementary diagnostic tool in a physician’s assessment of critically ill adult patients in the diagnosis of sepsis vs noninfectious systemic inflammation syndrome (SIRS), according to a study published in the American Journal of Respiratory and Critical Care Medicine.

Researchers performed a prospective observational non-interventional study of 249 individuals from 7 US sites (Baltimore, Maryland; Chicago, Illinois; Maywood, Illinois; Long Island, New York; Atlanta, Georgia; Murray, Utah; Salt Lake City, Utah), and 198 patients from the MARS consortium trial in The Netherlands (ClinicalTrials.gov Identifiers: NCT02127502 and NCT01905033, respectively) to evaluate the diagnostic ability of the molecular test Septicyte^TM LAB in distinguishing between sepsis and non-infectious systemic inflammation in critically ill adults and compare the findings with the retrospective physician diagnosis (RPD).

Data was analyzed by 3 panelists using 3 different RPD algorithms for classifying patients as having sepsis, SIRS, or indeterminate: consensus (2 panelists agreed), unanimous (all 3 panelists agreed), and forced (all panelists disagreed or deemed a case indeterminate; case review undergoes a second blinded independent case review and forced into either the sepsis or SIRS category).

The SeptiScore^TM values were overall significantly higher in patients with sepsis, with a receiver under the operator curve analysis providing area under the curve (AUC) values for unanimous, consensus, and forced RPD of 0.89, 0.85, and 0.82, respectively. When using a binary cutoff value of 3.1, the AUC values were 0.97, 0.94, and 0.92, respectively, as scores ≥3.1 were found to be indicative of sepsis and <3.1 indicative of SIRS.

When SeptiScores^TM were further broken down into numerical bands (band 1: 0 to 3.0; band 2: 3.1 to 4.4; band 3: 4.5 to 5.9; band 4: 6 to 10), there was a positive correlation between the probability of sepsis and band number, with bands 3 and 4 more often associated with a unanimous sepsis score (86.0%) compared with SIRS (29.8%).

Researchers concluded that SeptiCyte^TM LAB was successful in discriminating patients with sepsis from patients with SIRS with good reliability in an ethnically diverse patient population. The AUC had an overall range of 0.82 to 0.89, with the highest being a unanimous RPD and lowest with forced RPD (0.89 and 0.82, respectively).

Clinicians should consider the use of SeptiCyte^TM LAB in critically ill adults because it has good prognostic ability when integrated into a physician’s assessment in the clinical decision making process.

Disclosures: This study was funded by Immunexpress. Several authors disclosed financial relationships with pharmaceutical and medical device companies.

Reference

Miller, RR III, Lopansri BK, Burke, JP, et al. Validation of a host response assay, SeptiCyte^TM LAB, for discriminating sepsis from SIRS in the ICU [published online April 6, 2018]. Am J Resp Crit Care Med. doi:10.1164/rccm.201712-2472OC