Diagnostic accuracy: sensitivity and specificity

The diagnostic validity of Presepsin has been evaluated in numerous clinical studies. Comparisons of different medical scores and relevant biomarkers in sepsis diagnosis revealed an important role for PATHFASTTM Presepsin.

Improved 30 day mortality prediction (Fig. 3)
Presepsin showed superior risk of 30 day mortality prediction at admission in septic patients compared to APACHE II, GCS, MEDS, SOFA and procalcitonin.

Support of medical scores (Fig. 4A+B)
Quick-SOFA (qSOFA) was defined by The Third International Consensus Definitions for Sepsis and Septic Shock in 2016 in order to provide a simplified version of SOFA without the need of laboratory tests. It can be directly assessed at patient admission. For discrimination between uncomplicated sepsis and severe sepsis or septic shock Presepsin showed superior discriminatory power compared to clinical scores and biomarkers. Additionally simultaneous assessment by combining Presepsin and qSOFA improved the diagnostic validity significantly. Combination of Presepsin and qSOFA showed a detection rate for non-survivors of 93% and 67% and for patients with severe sepsis/septic shock of 92% and 58% whereas qSOFA alone only reached 67% and 58%, respectively. Presepsin showed also a predictive superiority compared to lactate and procalcitonin [4].

Presepsin and procalcitonin levels for mortality prediction (Fig. 5)
Evolution of Presepsin levels over time in survivors was significantly different from that in deceased patients in the ICU. PCT levels decreased rapidly and similarly in survivors and non-survivors whereas Presepsin clearly differentiates already after 24 hours between the two cases.
In comparison to survivors Presepsin levels in non-survivors stayed constantly high over the time period observed. Conversely, PCT levels fell rapidly and similarly from day 1 to 7 in survivors and non-survivors.
Presepsin appears as an early marker of mortality with better prognostic performance than PCT and can be used as an aid in risk stratification strategies in septic patients [6].
Patients with decreasing levels of Presepsin over 7 days in ICU were more likely to have received an early appropriate first-line empirical antibiotic therapy on day 1 than those with increasing levels [5].

Negative Predictive Value and cut off values (Fig. 6)
An important diagnostic factor is the high Negative Predictive Value (NPV) of Presepsin. In fact for healthy individuals, not affected by a clear bacterial outbreak, the values of Presepsin are below 200 pg/mL. A Presepsin cut off value of 1.622pg/ml excludes 30 day mortality by a Negative Predictive Value (NPV) of 98,5% [3]. Presepsin concentration is already related to the severity of the disease at the time of first presentation and may be useful in the differential diagnosis in patients presenting with clinical signs of SIRS and sepsis in the emergency department. In summary, based on the Presepsin values measured in the study patients with different disease severity degrees (SIRS, sepsis, severe sepsis or septic shock) and the close relationship between Presepsin and outcome decision thresholds for risk stratification could be established [1, 10].