SeptiCyte RAPID shows promise in pediatric sepsis study

Immunexpress said a multicenter study in Pediatric Critical Care Medicine found SeptiCyte RAPID helped distinguish sepsis from noninfectious inflammation in critically ill children. The results suggest the test could improve early decision-making when paired with routine clinical and laboratory data.

Why it matters: - Sepsis and noninfectious systemic inflammatory response syndrome can look similar in critically ill children. - Faster, more accurate differentiation could support earlier treatment when sepsis is likely and better antibiotic stewardship when it is not. - The study addresses a gap in pediatric validation for host-response sepsis tests.

What happened: - Immunexpress announced publication of a multicenter clinical validation study of SeptiCyte RAPID in Pediatric Critical Care Medicine. - The retrospective, noninterventional study evaluated 284 children ages 1 month to 18 years. - The children were enrolled across four studies at pediatric centers in the United States and Australia. - The test distinguished sepsis from noninfectious SIRS in critically ill children suspected of sepsis.

The details: - SeptiCyte RAPID is a sample-to-answer, cartridge-based host-response molecular test. - The test uses as little as 250 uL of whole EDTA blood. - SeptiCyte RAPID reports a SeptiScore from 0 to 15 in about one hour. - The score is reported across four interpretation bands that reflect increasing likelihood of sepsis. - In children with a consensus clinical diagnosis, SeptiCyte RAPID produced an area under the receiver operating characteristic curve of 0.83. - The test outperformed other clinical parameters used alone or in combination. - Adding six routine laboratory tests, including organ dysfunction variables, increased the AUC to 0.87. - Performance was consistent across infants and toddlers, children and adolescents. - No statistically significant difference appeared between the U.S. and Australian cohorts. - Among clinically adjudicated sepsis patients with positive blood cultures, 68.4% had a Band 4 result, the highest sepsis probability band. - Higher SeptiScores corresponded to a greater probability of sepsis, with a positive likelihood ratio of 3.51. - Lower SeptiScores helped rule out sepsis, with a likelihood ratio of 0.09. - The study authors concluded the test may be used with available clinical and laboratory parameters, including early organ dysfunction measures, to support earlier and more accurate identification of sepsis in children. - SeptiCyte RAPID is intended for use with clinical assessments, vital signs and other laboratory findings as an aid in differentiating infection-positive sepsis from non-infectious systemic inflammation. - The test runs on the Biocartis Idylla platform and is CE Marked in Europe. - SeptiCyte RAPID has FDA clearance in the U.S. for hospitalized adult patients suspected of sepsis and approval for adult and pediatric application by TGA in Australia.

Between the lines: - The study suggests host-response testing may add value because routine clinical signs alone can be insufficient in early pediatric sepsis evaluation. - Consistent performance across age groups and countries strengthens the case that the test may travel well across care settings. - The blood-culture subgroup result points to potential usefulness in identifying higher-risk patients who may need faster action. - Lead author Dr. Jerry Zimmerman of the University of Washington said the findings show promise for helping clinicians manage diagnostic uncertainty in real time.

What's next: - SeptiCyte RAPID may be considered alongside existing clinical and laboratory data in pediatric sepsis workups. - Further clinical use and additional validation could help define how the test fits into early sepsis pathways. - Immunexpress continues to position SeptiCyte technology as a tool for earlier and more confident decision-making in suspected sepsis.

The bottom line: - The study adds pediatric evidence that SeptiCyte RAPID can help separate sepsis from noninfectious inflammation and improve diagnostic confidence when used with routine clinical information. - More information is available through the company's social profile and video channel.