Validation of AIA-360 for Determination of Presepsin: A Useful Tool for the Diagnosis of Sepsis at the Emergency Department

Sepsis is a life-threatening condition, and clinicians should diagnose it as soon as possible to enable rapid intervention. The study aims to validate the AIA-360 Presepsin (PSEP) test for its use in determination in the diagnosis of septic patients after admission to emergency departments (ED). A total of 97 blood samples were collected from patients at the ED and from blood donors of Tor Vergata Hospital. Here, 15 samples were obtained from patients with a confirmed diagnosis of sepsis, and 44 samples with non-septic inflammatory condition. A control group of 38 samples from healthy subjects was also included. The non-septic inflammatory condition group and the confirmed sepsis group had a median of 874.40 pg/mL and 1467.10 pg/mL, respectively, while the control group showed a PSEP median value of 473.90 pg/mL, thus showing a significant statistical difference among all groups. The ROC curves highlighted a good sensitivity (93.33%) and specificity (76.19%) for PSEP values, suggesting the best cut-off point of 890 pg/mL. (p-value < 0.001; Mann–Whitney test). The PSEP test can improve and speed up the diagnosis of sepsis after admission to the ED with respect to other biomarkers, mainly due to its early kinetics.