Journal of Critical Care 29 (2014) 965–970

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Journal of Critical Care

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Usefulness of presepsin (sCD14 subtype) measurements as a new

marker for the diagnosis and prediction of disease severity of sepsis in
the Korean population☆,☆☆
Oh Joo Kweon, MD, Jee-Hye Choi, PhD, Sang Kil Park, MS, Ae Ja Park, MD, PhD ⁎
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea

a r t i c l e i n f o a b s t r a c t

Keywords: Purpose: Presepsin has recently emerged as a new useful sepsis marker, and our study is focused on the
Presepsin usefulness of presepsin as earlier detection and monitoring biomarker for sepsis comparing with other
Sepsis conventional biomarkers.
Septic shock
Materials and methods: We compared the mean values of presepsin, procalcitonin, interleukin 6, and high-
Infection
sensitivity C-reactive protein levels between infection group and noninfection group of study subjects and
assessed whether the values decreased during treatment. Furthemore, we evaluated the diagnostic accuracy
of presepsin in sepsis and compared the mean level of presepsin to the Acute Physiology and Chronic Health
Evaluation III score and mortality rate on the 30th day.
Results: Mean presepsin levels were significantly different between infection group and noninfection group
(1403.47 pg/mL vs 239.00 pg/mL). During treatment, mean levels of presepsin decreased significantly, and in
the receiver operating characteristic curve analysis, the area under curve value of presepsin was significantly
higher than that of other biomarkers. The presepsin levels did not correlate significantly with Acute
Physiology and Chronic Health Evaluation III scores and mortality rates on the 30th day.
Conclusions: Presepsin showed significantly higher values in infection group than in noninfection group. The
diagnostic accuracy of presepsin was higher than other conventional biomarkers. For early diagnosis and
treatment of bacterial sepsis, presepsin could be a more useful marker than the other markers.
© 2014 Elsevier Inc. All rights reserved.

1. Introduction Various biomarkers such as procalcitonin (PCT), interleukin 6 (IL-6),

Sepsis is defined as a systemic inflammatory response to infection,
and it is an increasingly common cause of morbidity and mortality,
particularly in the elderly, immunocompromised, and critically ill
patients [1,2]. It is well known that an early diagnosis and treatment
of sepsis with appropriate drugs can improve the prognosis and increase
the survival rate in patients with sepsis [3]. Blood culture is considered
as the criterion standard for diagnosis of sepsis, but it takes several days
to obtain the blood culture results. In addition, blood culture has a low
sensitivity and a high contamination rate. Therefore, the diagnosis of
sepsis generally depends on the physician’s experience; furthermore,
the nonspecific symptoms of sepsis make it difficult to establish the
diagnosis based on clinical findings alone [1].
☆ Funding: This research received no specific grant from any funding, agency in the
public, commercial, or not-for-profit sectors.
☆☆ Conflicts of interest: The authors have no conflicts of interest or financial ties
to disclose.
⁎ Corresponding author at: Department of Laboratory Medicine, Chung-Ang
University College of Medicine, Heukseok-ro 102, Dongjak-gu, Seoul 156-755, Korea.
Tel.: +82 2 6299 2717; fax: +82 2 6263 6410.
E-mail address: ajcp@unitel.co.kr (A.J. Park).
tumor necrosis factor, and high-sensitivity C-reactive protein (hs-CRP)
are used as the diagnostic markers for bacterial sepsis. Among them, PCT
is known to have a high specificity for diagnosing sepsis compared with
the other biomarkers. But in conditions without bacterial infection, such
as severe trauma, invasive surgical procedure, and critical burn injuries,
PCT levels could increase beyond the reference range, thus resulting in
false-positive results [4].
Cluster of differentiation 14 (CD14) is glycoprotein that is expressed
in macrophages, monocytes, and granulocytes, and it is the receptor for
lipopolysaccharide (LPS)/LPS binding protein (LPBP) complex. The LPS-
LPBP-CD14 complex is released into the circulation by shedding from
the cell membrane yielding soluble CD14 (sCD14). However, plasma
protease activity also generates another sCD14 molecule called sCD14
subtype or presepsin, a 13-kd protein that is a truncated N-terminal
fragment of CD14 [5]. The mechanisms of presepsin release are not well
known, but one of the mechanisms is related to the phagocytosis
process and cleavage with lysozomal enzymes of microorganism [6]. It is
known that the presepsin level is elevated before the elevation of IL-6
and PCT levels along with the occurrence of bacteremia, and many
studies that compared presepsin with other conventional markers such
as PCT and IL-6 demonstrated its superiority in sensitivity and specificity
for diagnosing sepsis compared with the other markers [6-8].

http://dx.doi.org/10.1016/j.jcrc.2014.06.014
0883-9441/© 2014 Elsevier Inc. All rights reserved.
966 O.J. Kweon et al. / Journal of Critical Care 29 (2014) 965–970
Presepsin was originally measured by sandwich enzyme-linked
immunosorbent assay, but this was not convenient and took a long
time to obtain the results [5,9,10]. Therefore, this test was largely
substituted by a fully automated point-of-care presepsin assay based
on the chemiluminescent enzyme immunoassay, which uses whole
blood specimens [9].
We measured the presepsin level in various pathologic conditions
and at different time points and compared its clinical usefulness as an
early diagnostic marker for bacterial sepsis with that of other
conventional markers such as IL-6, PCT, and hs-CRP in Korean
patients. We also evaluated the correlation of presepsin level with
disease severity using the Acute Physiology and Chronic Health
Evaluation III scores (APACHE III score) and with mortality on the 30th
day [11].
2. Patients and methods
2.1. Patient inclusion and exclusion criteria
The subjects visited the emergency department of Chung-Ang
University Hospital, Seoul, Korea, from September 2012 to June 2013
(a 10-month period). We divided the subjects into 4 groups
according to criteria of The American College of Chest Physicians/
Society of Critical Care Medicine Consensus Conference and systemic
inflammatory response syndrome (SIRS), sepsis, severe sepsis, and
septic shock [1].
Systemic inflammatory response syndrome group subjects were
defined by the patients with 2 or more of the following conditions:
(1) fever (oral temperature N38°C) or hypothermia (b 36°C),
(2) tachypnea (N 24 breaths per minute), (3) tachycardia (heart rate
N 90 beats per minute), and (4) leukocytosis (N 12 000/L) or
leukopenia (b 4000/L) or more than 10% band forms of neutrophil.
Sepsis group were defined by the people with SIRS as a result of
bacterial infection. Actually, not only bacterial infection but also
fungal, viral, or parasite infections can all cause sepsis, but our study
focused only on bacterial infection because bacterial infection is the
most common cause of sepsis. The SIRS subjects with positive blood
culture results for bacteria were involved in sepsis groups. Severe
sepsis group were defined by the sepsis patients with more than one
of organ dysfunction signs including (1) cardiovascular: arterial
systolic blood pressure less than 90 mm Hg or mean arterial pressure
less than 70 mm Hg that responds to administration of intravenous
fluid, (2) renal: urine output less than 0.5 mL/kg per hour for 1 hour
despite adequate fluid resuscitation, (3) respiratory: PaO2/fraction of
inspired oxygen less than 250, (4) hematologic: platelet count less
than 80 000/L or 50% decrease in platelet count from highest value
recorded over previous 3 days, (5) unexplained metabolic acidosis: a
pH 7.30 or a base deficit 5.0 mEq/L and a plasma lactate level more
than 1.5 times upper limit of normal for reporting laboratory, (6)
pulmonary artery wedge pressure less than 12 mm Hg or central
venous pressure less than 8 mm Hg with adequate fluid resuscitation,
and (7) acute alteration of mental status. Lastly, septic shock was
defined as a sepsis with hypotension (a systolic blood pressure of
b 90 mm Hg or its reduction by 40 mm Hg or more from baseline in the
absence of other causes for hypotension) despite adequate fluid
resuscitation along with organ dysfunction signs or a sepsis patients
who need to be used inotropics or vasopressors for maintaining a
systolic blood pressure of more than 90 mm Hg or mean arterial
pressure of more than 70 mm Hg.
The number of subjects in each group was 20, 25, 22, and 26,
respectively. In addition, 25 healthy control subjects were assessed.
Thus, a total of 118 subjects were enrolled in our prospective
cohort study. We excluded the patients with chronic renal failure
(CRF) or a history of resuscitation because patients with these
conditions were known to have falsely elevated presepsin levels
with unknown causes [7]. Similarly, severe trauma patients and
patients with severe burns were excluded because of falsely
elevated PCT levels [4]. And patients who were treated for infection
before admitted to hospital were also excluded for the reliable data
of biomarkers.
On the first day, blood specimens were collected immediately after
admission to the hospital; and on the 3rd and 7th day, blood
specimens were collected early in the morning. Each specimen was
assigned a randomized identification code, and all analysis was
performed in a blinded manner. This study was approved by
Institutional Review Board of the Chung-Ang University Hospital.
2.2. Measurement methods
Presepsin levels were measured using whole blood specimens
that were collected in EDTA tube and were analyzed within
4 hours after collection. Presepsin measurements were performed
using PATHFAST presepsin assay kit with PATHFAST analyzer
(Mitsubishi Chemical Medience Corporation, Tokyo, Japan), which
was based on noncompetitive chemiluminescent enzyme immu-
noassay. All of the procedures were conducted according to the
manufacturer’s instructions, and the presepsin value in whole
blood samples was automatically corrected according to the
hematocrit value.
Measurements of PCT, IL-6, and hs-CRP were performed using SST
serum with VIDAS BRAHMS PCT assay (BioMerieux, Paris, France),
Quantikine enzyme-linked immunosorbent assay IL-6 assay (R&D
Systems, Minneapolis, MN), and Olympus C-reactive protein Latex
assay (Olympus, Tokyo, Japan), respectively.
2.3. Statistical analysis
The statistical analyses were performed using independent t test
and one-way analysis of variance for assessing the differences in
biomarker levels among different groups. For assessing the relation-
ship of presepsin levels with APACHE III score, both independent t test
and regression curve analysis were conducted. A receiver operating
characteristic (ROC) curve analysis was performed for assessing
the diagnostic accuracy of presepsin and other biomarkers in sepsis.
P b .05 were regarded as significant. Data presented in figures are
expressed as mean ± SD value.
3. Results
3.1. Patient characteristics
Characteristics of 118 studied subjects are shown in Table 1.
Among total 118 subjects, 59 were male, and 59 were female. Mean
ages of normal, SIRS, sepsis, severe sepsis, and septic shock group
subjects were 50.64, 63.00, 65.74, 59.67, and 61.19 years old,
respectively. Study subjects were with various diagnosis including
pneumonia, acute pyelonephritis, urinary tract infection, cerebro-
vascular disease, hepatobiliary system infection, pelvic inflammatory
disease, and others. For pathogens of sepsis, severe sepsis, and septic
shock groups, gram-negative bacteria were slightly more than gram-
positive bacteria.
3.2. Levels of 4 sepsis biomarkers in different condition
We measured presepsin, PCT, IL-6, and hs-CRP levels in the
subjects assigned to 5 different groups on the day of admission.
With respect to presepsin levels, there were significant
differences among normal, SIRS, sepsis, and severe sepsis groups,
and the presepsin levels increased from normal to severe sepsis
groups. But there were no differences in presepsin levels between
severe sepsis and septic shock groups (Fig. 1A). The mean presepsin
level in the infection groups: sepsis + severe sepsis + septic
 O.J. Kweon et al. / Journal of Critical Care 29 (2014) 965–970 967

Table 1
Patient characteristics of 118 studied subjects

Normal SIRS Sepsis Severe sepsis Septic shock Total

n 25 20 25 22 26 118
Male 11 (44%) 12 (60%) 13 (52%) 14 (63.6%) 9 (34.6%) 59 (50%)
Female 14 (56%) 8 (40%) 12 (48%) 8 (36.4%) 17 (65.4%) 59 (50%)
Mean age [min-max] 50.64 [20-73] 63.00 [29-89] 65.74 [29-91] 59.67 [36-83] 66.81 [38-78] 61.19 [20-91]
Diagnosis
Pneumonia – 4 3 7 11 –
Acute pyelonephritis – 1 6 4 4 –
Urinary tract infection – 1 4 2 5 –
Cerebrovascular disease – 3 2 1 – –
Hepatobiliary system infection – 3 4 5 1 –
Pelvic inflammatory disease – – – – 1 –
Prostatitis – – – 1 –
Gastrointestinal tract disease – – 2 – 2 –
Endocarditis – – 1 – – –
Others – 8 3 3 1 –
Gram positive – – 6 (24%) 11 (50%) 16 (61.5%) –
Gram negative – – 19 (76%) 11 (50%) 10 (38.5%) –

shock groups was significantly higher than that in the noninfec-
tion groups; normal control and SIRS groups (1403.47 pg/mL vs
239.00 pg/mL; P b .01).
Results of PCT measurements showed that there was a significant
difference in PCT levels between SIRS and sepsis groups; a much
higher PCT value was observed in the sepsis group (P b .01). But data
showed no differences in PCT levels among sepsis, severe sepsis, and
septic shock groups (Fig. 1B).
Interleukin 6 levels in the SIRS, sepsis, severe sepsis, and septic
shock groups were significantly higher than the IL-6 level in the
normal group (P b .01), but there were no differences in IL-6 levels
among these 4 groups (Fig. 1C).
Similar to IL-6 levels, hs-CRP levels were higher in the 4 patient
groups than in the normal control group. Although P values were
statistically significant, there was no tendency in hs-CRP levels among
these 4 patient groups (Fig. 1D).

Fig. 1. Levels of the 4 sepsis biomarkers in different conditions on the first day; presepsin (A) PCT (B), IL-6 (C), and hs-CRP (D). Full lines indicate the median values of biomarkers,
and dashed lines indicate the mean values of biomarkers.
968 O.J. Kweon et al. / Journal of Critical Care 29 (2014) 965–970

Table 2 Table 3
Mean values of the 4 sepsis biomarkers in infection group on the first, third, and Area under curve from the ROC curve analysis and the optimal cut-off value of 4
seventh day biomarkers and their diagnostic accuracy at the optimal cut-off value

Presepsin (pg/mL) PCT (ng/mL) IL-6 (pg/mL) hs-CRP (mg/L) AUC Cut-off value Sensitivity (%) Specificity (%) PPV (%) NPV (%)

First day 1403.47 22.05 0.30 139.92 Presepsin 0.937 430.00 pg/mL 87.7 82.2 88.9 80.4
Third day 946.37 15.42 0.17 130.20 PCT 0.915 1.00 ng/mL 86.3 86.7 91.3 79.6
Seventh day 683.70 2.93 0.09 66.59 IL-6 0.869 0.02 pg/mL 98.6 66.7 82.8 96.8
hs-CRP 0.853 11.40 mg/L 98.6 66.7 84.8 84.6

3.3. Changes in biomarker levels during treatment
In infection groups, we measured the biomarker levels on the first
(day of admission), third, and seventh day to assess the changes
in biomarker levels, while treating the patients and with the passage
of time.
There were a significant decrease in presepsin levels between the
first and the third day (1403.47 pg/mL to 946.37 pg/mL; P b .01), but
there were no differences in presepsin levels between the third and
the seventh day (Table 2). Procalcitonin and IL-6 levels were
significantly decreased with the passage of time (P b .01), but there
was a more significant decrease in PCT and IL-6 values between the
third and the seventh day than between the first and the third day.
The hs-CRP level was no different between the first and the third day,
but there was a significant decrease in the hs-CRP level on the seventh
day (P b .01).
arterial pressure, arterial blood pH, heart rate, respiratory rate,
sodium level (serum), potassium level (serum), creatinine level,
hematocrit, white blood cell count, blood urea nitrogen level, urine
output, serum albumin level, bilirubin level, glucose level, and
Glasgow Coma Scale [11]. Acute Physiology and Chronic Health
Evaluation III scores were calculated in all of the patients who were
admitted to the intensive care unit, and we divided these patients into
3 groups according to the APACHE III score: 0 to 10, 11 to 30, and more
than 31. There was a tendency for an increase in presepsin values with
an increase in APACHE III scores but the P N .05. We also analyzed
these data using regression curve analysis. In the regression curve
analysis, the R value between APACHE III scores and presepsin levels
was 0.39, so there was no significant relationship between APACHE III
scores and presepsin levels (Fig. 3).
3.6. The analysis of mortality rates on the 30th day

3.4. Diagnostic accuracy of the 4 biomarkers for sepsis We investigated whether the patients in the infection groups
survived until the 30th day and evaluated the relationship between
Receiver operating characteristic curve analysis was performed for
assessing the diagnostic accuracy of these 4 biomarkers of sepsis. The
results showed that the area under curve (AUC) value of presepsin was
the highest among the 4 biomarkers followed by the value of PCT, IL-6,
and hs-CRP. When we used a presepsin cut-off value of 430.00 pg/mL for
diagnosing sepsis, sensitivity, specificity, positive predictive value (PPV),
and negative predictive value (NPV) were 87.7%, 82.2%, 88.9%, and 80.4%,
respectively. Thus, presepsin was superior biomarker compared with the
other markers in diagnosing sepsis (Fig. 2 and Table 3).

3.5. Correlation between presepsin values and APACHE III score

Acute Physiology and Chronic Health Evaluation III score is a

severity index that is based on age, temperature (rectal), mean

Fig. 3. APACHE III score and presepsin level on the first day. As the APACHE III score
Fig. 2. The ROC curve analysis of 4 biomarkers in the infection groups (sepsis + severe increased, the mean presepsin level on the first day increased, but it was not
sepsis + septic shock groups). statistically significant.
 O.J. Kweon et al. / Journal of Critical Care 29 (2014) 965–970
Fig. 4. The mortality rate on the 30th day and the presepsin levels on the first day.
mortality rate on the 30th day and presepsin values on the first day.
The results showed that there was no relationship between mortality
on the 30th day and presepsin values on the first day (Fig. 4).
4. Discussion
Blood culture is considered as the criterion standard for establish-
ing the diagnosis of bacterial sepsis, but several drawbacks such as
high contamination rate, long turnaround time, and low sensitivity
have led to the development of several biomarkers for establishing the
diagnosis of sepsis. Among them, PCT was recognized as the best
conventional biomarkers for diagnosing bacterial sepsis. But, falsely
elevated PCT levels were observed in several conditions, and
therefore, the specificity of PCT was doubtful. For this reason, there
was a need to identify new diagnostic markers, and presepsin is one of
those biomarkers. To the best of our knowledge, this is the first study
to assess the usefulness of presepsin in the Korean population, and we
demonstrated that presepsin was a superior diagnostic biomarker
compared with the other conventional markers as has already been
shown in studies conducted in other countries [6,7,12,13].
In our study, we measured the levels of 4 biomarkers, PCT, IL-6,
hs-CRP, and presepsin in patients with different conditions on the
day of admission. Presepsin values were significantly increased
among normal, SIRS, sepsis, and severe septic shock groups.
Presepsin values were significantly higher in the infection groups
than in the noninfection groups. Procalcitonin values, which are
already being used in a clinical setting, were also significantly
different between the infection and noninfection groups, but there
was no difference in PCT levels between sepsis and severe sepsis
groups. Interleukin 6 and hs-CRP levels were increased from normal
to SIRS groups, but there were no differences in IL-6 and hs-CRP levels
among SIRS, sepsis, severe sepsis, and septic shock groups. Therefore,
these 2 biomarkers had a lower specificity than presepsin and PCT in
diagnosing infections.
To assess the changes in biomarker levels during treatment of
these patients, we measured the biomarker levels at different time
point (first, third, and seventh day). Presepsin showed a significant
decrease from the first to the third day. Procalcitonin and IL-6 levels
continuously decreased from the first to the seventh day. The hs-CRP
levels were no different between the first and the third day, but there
were a significant decrease in the hs-CRP level on the seventh day.
According to the results of our study, presepsin, PCT, and IL-6 levels
decreased more rapidly after treatment than the hs-CRP level.
The ROC curve analysis demonstrated that presepsin was a
superior diagnostic markers compared with the other conventional
969
biomarkers. The AUC value of presepsin was 0.937; it was higher than
the AUC value of PCT of 0.915. This result was similar to other studies.
Shozushima et al [6] performed the ROC curve analysis and stated that
the AUC value for presepsin, PCT, IL-6, and C-reactive protein were
0.879, 0.666, 0.658, and 0.856, respectively. Endo et al [7] also
reported that the AUC values and AUC value of presepsin was 0.908,
the AUC value of PCT was 0.905, and the AUC value for IL-6 was 0.825.
Cakir Madenci et al [12] studied the presepsin levels in burn patients
with sepsis, and they observed similar diagnostic performances of
presepsin with PCT (AUC, 83.4 and 84.7, respectively). Furthermore,
Liu et al [13] reported the AUC values of 0.820 for presepsin and AUC
values of 0.724 for PCT.
Optimal cut-off value of presepsin in our study for the diagnosis of
sepsis was different compared with that in other studies; in our study,
the optimal cut-off value of presepsin was 430 pg/mL; but in the study
by Shozushima et al [6], the optimal cut-off value of presepsin was
399 pg/mL; in the study by Endo et al [7], the optimal cut-off value of
presepsin was 600 pg mL; in the study by Cakir Madenci et al [12], the
optimal cut-off value of presepsin was 542 pg/mL; and in the study by
Liu et al [13], the optimal cut-off value of presepsin was 317 pg/mL.
The reasons for the differences in the optimal cut-off value of
presepsin might be the study design, especially the patient inclusion
criteria. We excluded the patients with CRF, burn patients, and severe
trauma patients from this study, but the other studies did not exclude
these patients; falsely elevated values of presepsin or PCT are
observed in these conditions.
Although there was no statistically significant relationship
between the presepsin level and APACHE III score in our study, a
tendency for an increase in the presepsin level along with an increase
in the APACHE III was demonstrated (P N .05). Shozushima et al [6]
had reported that the presepsin level was correlated with the APACHE
II score. One of the causes for this discrepancy can be the number of
patients studied. In the study by Shozushima et al [6], the APACHE II
score was evaluated in a total of 104 patients, but in our study, the
APACHE III score was evaluated in only 37 patients who were
admitted to the intensive care unit. But because the APACHE III score
is based on the APACHE II score, adding 5 additional variables (blood
urea nitrogen level, urine output, serum albumin level, bilirubin level,
and glucose level) and reformatting the Glasgow Coma variables, we
assume that if the number of subjects, in whom the APACHE III score
was evaluated, was increased, our results would be similar to the
results of the study by Shozushima et al [6].
In our study, the mortality rates on the 30th day did not correlate
with the presepsin levels on the first day. There was no tendency for
an increase in the mortality rate with an increase in the mean values
of presepsin. But Liu et al [13] reported that there were significant
differences in the mean levels of presepsin between the 28-day
survivors and nonsurvivors (412 pg/mL vs 744 pg/mL; P b .00001). We
compared the mean values of presepsin on the first day between the
survivors and nonsurvivors, but there were no statistically significant
differences (data not shown). Therefore, further studies should be
performed to investigate the relationship between the mortality rate
and the initial presepsin levels.
Our study had several limitations. First of all, we focused only on
bacteria as the causative organisms of sepsis, not on fungus, virus, and
parasites. Thus, additional studies evaluating the effect of microor-
ganisms other than bacteria to level of presepsin values are needed to
be performed. And we could not assess the effect of diagnoses of study
subjects to the biomarker levels. Because the study subjects were with
various diagnoses, there were not enough subject numbers in each
diagnosis for statistic analysis. Finally, we did not exclude the patients
with acute kidney injury (AKI) patients. Because corticotropin-
releasing factor could results in falsely increased presepsin values,
AKI also had potential to cause falsely elevated results of presepsin
levels. In our study, there were only 5 patients with AKI, and
additional evaluation for those effects had not been performed.
970 O.J. Kweon et al. / Journal of Critical Care 29 (2014) 965–970
5. Conclusion
In our study, the mean presepsin levels were significantly different
between the infection and noninfection groups, and hence, presepsin
could be one of the useful markers for establishing an earlier diagnosis
of bacterial sepsis in the Korean population. Compared with the AUC
value of PCT, the AUC of presepsin was slightly but significantly
higher. Furthermore, the presepsin levels were different between
sepsis and severe sepsis groups, but the PCT levels were not different
between these 2 groups. Correlation of the presepsin levels with
APACHE III score and mortality rate should be evaluated in a future
study with a larger number of subjects.
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