Clinical Performance

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Intended Use

・Aid the diagnosis and prognosis of sepsis
・Assessment of the degree of septic severity
・Aid the risk stratification of critically ill septic patients

Presepsin reflects the development from SIRS to severe sepsis

 Concentration of Presepsin is significantly higher in sepsis or severe sepsis patients than normal subjects and SIRS patients [1]. This suggests that Presepsin increases specifically with bacterial infections.

Presepsin reflects the development from SIRS to severe sepsis

Comparison of Presepsin values in different pathological conditions
192 blood specimen collection points (normal, 22; local infection, 28; SIRS, 41; sepsis, 87; and severe sepsis, 14) were collected from 41 patients. Classification into SIRS, sepsis, and severe sepsis was based on definitions proposed by the ACCP/SCCM.

Correlation of Presepsin value and APACHE II score

 Presepsin value has a good correlation with clinical signs, such as Acute Physiology and Chronic Health Evaluation II (APACHE II) score, which is an index of severity [1]. This suggests that Presepsin accurately reflects patient condition.

Correlation of Presepsin value and APACHE II score

Correlation of presepsin value and APACHE II score

ROC Analysis

 Receiver Operating Characteristics (ROC) analysis was conducted with four sepsis diagnostic markers (Presepsin, PCT, IL-6 and CRP) [1]. The area under the curve (AUC) of Presepsin calculated from the ROC curve was 0.845; it was higher than the AUC of PCT (0.652), CRP (0.815), or IL-6 (0.672). When the cutoff value of presepsin was set at 399 pg/ml, its clinical sensitivity was 80.3% and clinical specificity 78.5%.

ROC analysis with four sepsis diagnostic markers

ROC analysis with four sepsis diagnostic markers

Early diagnosis and high specificity

 This patient was admitted into the hospital with extensive burns. He was diagnosed as SIRS at Day 0 and this turned into sepsis from Day 5. Presepsin began to increase earlier than PCT and CRP, and discriminated sepsis from SIRS [1].

Clinical course in burn patient

Clinical course in burn patient
The patient was admitted into hospital with extensive burns that covered 76% of his body. Test data on arrival included elevated white blood cell (WBC) count of 38,880/ll, and a diagnosis of SIRS was made. On Day 6, staphylococci were isolated by blood culture.

High Specificity and Sensitivity

 Presepsin and PCT levels were compared between healthy and sepsis groups. Presepsin concentration was 2,363 ± 2,161 pg/ml in the sepsis group and 123 ± 67.6 pg/ml in the healthy group. Meanwhile PCT concentration was 0.024 ± 0.019 ng/ml in the healthy group and 10.98 ± 28.93 ng/ml in the sepsis group [2].
This suggests that Presepsin has high specificity and sensitivity for sepsis diagnosis.

Comparison of Presepsin and PCT concentrations

Comparison of Presepsin and PCT concentrations
The serum Presepsin and PCT levels were compared between healthy (n = 20) and sepsis groups (n = 20). The sepsis group was diagnosed with suspected or confirmed sepsis by blood culture.

Presepsin elevates early in sepsis condition

Plasma Presepsin levels were elevated earlier than IL-6 along with occurrence of blood bacteria in a rabbit cecal ligation and puncture (CLP) model. This result suggests that Presepsin is useful in determining the prompt initiation of anti-sepsis therapy [3].

The time course of Presepsin and IL-6 levels in the CLP model.

The time course of Presepsin and IL-6 levels in the CLP model.
The number of bacteria in blood at 2 h was 2.94 ± 0.60 ×105 colony forming units (Mean±S.E.M. of 7 animals).

[1]  Shozushima T, Takahashi G, Matsumoto N, Kojika M, Okamura Y, Endo S.
Usefulness of presepsin (sCD14-ST) measurements as a marker for the diagnosis and severity of sepsis that satisfied diagnostic criteria of systemic inflammatory response syndrome.
J Infect Chemother. 2011 Dec;17(6):764-9. Epub 2011 May 12.

[2]  Okamura Y, Yokoi H.
Development of a point-of-care assay system for measurement of presepsin (sCD14-ST).
Clin Chim Acta. 2011 Nov 20;412(23-24):2157-61. Epub 2011 Aug 3.

[3]  Katsuki Naitoh et al.,
The new sepsis marker, sCD14-ST (PRESEPSIN), induction mechanism in the rabbit sepsis models.
Presentation of SEPSIS 2010