A molecular host response assay, called SeptiCyte Lab, holds promise as a tool to distinguish between sepsis and noninfectious systemic inflammation (SIRS), reported researchers in an industry-funded study.
Sepsis is a complex and hard-to-diagnose condition, noted two members of the editorial advisory board of CHEST Physician® in interviews. To make things more complicated, there’s not even a standard definition of sepsis, explained board member Nirmal S. Sharma, MD, of the University of South Florida, Tampa.
Dr. Nirmal S. Sharma
“Although newer sepsis definitions have been proposed, all of them have pitfalls and are not used universally. Additionally, the presence of inflammatory response leading to suspicion of sepsis can be due to a new infection or underlying disease processes, thus making it difficult to identify the possible cause,” said Dr. Sharma. “Culture-negative cases due to the use of antibiotics prior to suspicion/onset of sepsis can further muddle the picture. Finally, in certain subsets of patients, such as the immunocompromised and elderly, the signs of sepsis may be delayed due to inadequate/dampened immune response, thus making early diagnosis difficult.”
Blood testing can provide information about germs that are causing an infection, but “they often take several days, and we need to start the antibiotics before we have those results,” added Daniel R. Ouellette, MD, FCCP, the other board member interviewed.
The SeptiCyte Lab assay, which was approved by the FDA for use in diagnosing sepsis in 2017, was developed to help physicians distinguish sepsis from SIRS in patients during their first day of ICU treatment, noted the authors of the new study in the American Journal of Respiratory and Critical Care Medicine.
This new tool seems to overcome some of the obstacles encountered when other diagnostic methods are used to determine if a patient has sepsis.
Russell R. Miller III, MD, FCCM, and his colleagues performed their SeptiCyte Lab assay on patients’ blood samples; this involved real-time, reverse-transcription, quantitative polymerase chain reaction screening designed to analyze the relative expression levels of four genes. The testing procedure took approximately 6 hours from the draw of the blood sample, according to the study, which was recently published online.