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European Journal of Trauma Original Article

Quantitative versus Semiquantitative


Procalcitonin Measurement
Experience in a Trauma Intensive Care Unit

Linda E. Pelinka1, Katharina Sendova2, Walter Mauritz2, Heinz Redl1

Abstract and highly increased (> 2 ng/ml) readings are usually


Background: Procalcitonin, an excellent marker of sep- correct. Because of the rate of incorrectly low readings,
sis, is measured in trauma intensive care units by a the PCT-Q® test is unreliable for trauma patients.
standard quantitative test. Recently, a quicker semi-
quantitative test has become available. The aim of this Key Words
study was to compare both tests to determine whether Trauma intensive care · Sepsis marker · Sensitivity ·
the quicker new test is as reliable as the standard test Specificity
for trauma patients.
Patients and Methods: This prospective 4-month study Eur J Trauma 2003;29:81–4
included all severely traumatized patients admitted to DOI 10.1007/s00068-003-1233-4
our intensive care unit. Parallel procalcitonin measure-
ments were performed daily, comparing the standard
LUMItestPCT® to the categorization (normal < 0.5
ng/ml, moderately increased 0.5–2 ng/ml, or highly Introduction
increased > 2 ng/ml) by the quicker PCT-Q® test (both Procalcitonin is an excellent marker of sepsis of various
B.R.A.H.M.S.-Diagnostica GmbH, Henningsdorf, Ger- origins [1–3], ranging from neonatal sepsis [4] to trans-
many). plant rejection [5, 6] and acute pancreatitis [7, 8] with a
Results: Procalcitonin was measured in 167 samples high positive as well as negative predictive value in non-
from 15 patients (Injury Severity Score 29 ± 13). Among leukopenic patients [9]. In the trauma intensive care set-
the increased procalcitonin levels (increased LUMItest- ting, early identification of patients who are developing
PCT®), the PCT-Q® test picked up only 14 of 38 samples sepsis and might benefit from early intensive manage-
(36.8%). Among the normal procalcitonin levels (nor- ment and/or surgical revision is of utmost importance.
mal LUMItestPCT®) the PCT-Q® test classified 127 of 129 To help accomplish this, procalcitonin has been meas-
samples (98.4%) the same, i.e. correctly, and two sam- ured routinely in our trauma intensive care unit for sev-
ples (1.6%) moderately increased, i.e. too high. Com- eral years by means of a quantitative test. Recently, a
pared to the LUMItestPCT®, the PCT-Q® test has a low semiquantitative test which is twice as quick as the stan-
sensitivity of 44% and a high specificity of 97%. dard quantative test has become available. The aim of
Conclusions: The semiquantitative PCT-Q® test is high- this study was to compare the quicker semiquantitative
ly specific but far less sensitive than the LUMItestPCT®. test to the standard quantitative test in order to deter-
Normal procalcitonin readings by the PCT-Q® test are mine whether the quicker test is equally reliable and
often incorrectly low, while moderately (0.5–2 ng/ml) thus suitable for the trauma intensive care setting.

1
Ludwig Boltzmann Institute for Experimental and Clinical Trauma-
tology, Vienna, Austria,
2
Department of Anesthesiology and Intensive Care Medicine, Lorenz
Boehler Trauma Center, Vienna, Austria.
Received: July 4, 2002; revision accepted: February 20, 2003

European Journal of Trauma 2003 · No. 2 © Urban & Vogel 81


Pelinka LE, et al. Quantitative vs Semiquantitative Procalcitonin Measurement

Patients and Methods 100 98.4


PCT-Q ® higher than LUMItestPCT ®
This prospective study was conducted for 4 months and PCT-Q ® same as LUMItestPCT ®
included all severely traumatized patients admitted to PCT-Q ® lower than LUMItestPCT ®
the intensive care unit of our trauma center. 80
Prior to inclusion into the study, informed written

% of readings per category


65.6
consent was obtained from the next of kin. The trial pro-
tocol was approved by an ethics committee in accor- 60
dance with the Declaration of Helsinki. Procalcitonin 50.0 50.0

was measured daily, both by the quantitative immunolu-


40
minometric LUMItestPCT® and by the semiquantita- 34.4
tive immunochromatographic PCT-Q® test (both
B.R.A.H.M.S.-Diagnostica GmbH, Henningsdorf, Ger-
20
many). According to the manufacturer, both the PCT-
Q® test and the LUMItestPCT® can measure procalci-
1.6
tonin in serum and in plasma. We performed all 0
procalcitonin measurements in serum according to the Normal Moderately Highly increased
instructions provided by the manufacturer. According- (< 0.5 ng/ml) increased (> 2 ng/ml)
(< 0.5–2 ng/ml)
ly, we used a luminometer (Lumat LB 9507, Bethold
Procalcitonin readings
GmbH, Bad Wildbad, Germany) for the procalcitonin
readings with the LUMItestPCT®. Procalcitonin levels Figure 1. Comparison of procalcitonin readings by semiquantitative
PCT-Q® test (three categories: normal < 0.5 ng/ml, moderately
were measured by the LUMItestPCT® and compared to
increased 0.5–2 ng/ml, and highly increased > 2 ng/ml) versus quanti-
the corresponding categorization (< 0.5 ng/ml, 0.5–2 tative LUMItestPCT®. Among the samples with normal procalcitonin
ng/ml, and > 2 ng/ml) by the PCT-Q® test. readings (by LUMItestPCT®), the PCT-Q® test classified 98.4% the
same, i.e., correctly, and the remaining 1.6% too high. Among the sam-
ples with moderately increased procalcitonin readings (by LUMItest-
Statistics PCT®), the PCT-Q® test classified 34.4% the same, i.e., correctly, the
For sensitivity (increased LUMItestPCT® and PCT-Q® remaining 65.6% too low, and none too high. Among the samples
test/LumitestPCT®) and specificity (normal LUMItest- with highly increased procalcitonin readings (by LUMItestPCT®), the
PCT® and PCT-Q® test/LumitestPCT®), raw and simul- PCT-Q® test classified 50% the same, i.e., correctly, and the remaining
50% too low.
taneous 95% confidence intervals were calculated from
the percentiles of 10,000 bootstrap resamples [10]. To
adjust for the different numbers of samples per patient, Thus, the PCT-Q® test only picked up 14 of all 38
the values were weighted by the reciprocal individual increased procalcitonin levels (36.8%). Among the nor-
sample size. The bootstrap resamples were taken by a mal procalcitonin levels (as measured by the LUMItest-
nested design. The values between separate patients PCT®), however, the PCT-Q® test classified 127 of 129
and in individual patients were resampled. The statisti- samples (98.4%) the same (< 0.5 ng/ml), i.e., correctly,
cal calculations were performed with R 1.6.2. and only two of 129 samples (1.6%) as moderately
increased (0.5–2 ng/ml), i.e. incorrectly (Figure 1). We
Results found that normal procalcitonin readings (< 0.5 ng/ml) by
Procalcitonin was measured daily in 167 samples from 15 the PCT-Q® test were often incorrectly low (falsely nor-
severely traumatized patients (Injury Severity Score 29 ± mal), while moderately (0.5–2 ng/ml) and highly
13) for an average of 11.6 days (range 3–25 days). Among increased (> 2 ng/ml) readings were usually correct.
the increased procalcitonin levels (as measured by the The sensitivity was low (44%), whereas the speci-
LUMItestPCT®), the PCT-Q® test classified three of six ficity was high (97%) for the PCT-Q® test compared to
highly increased procalcitonin levels (50%) and eleven of the LUMItestPCT®. The PCT-Q® test only picked up
32 moderately increased procalcitonin levels (34.4%) the increased procalcitonin levels in 14 (increased PCT-Q®
same (> 2 ng/ml and 0.5–2 ng/ml, respectively), i.e. cor- test and increased LUMItestPCT®) of 38 samples
rectly (Figure 1). The PCT-Q® test classified all remain- (Table 1a). The sensitivity of the PCT-Q® test was 44%.
ing samples with increased procalcitonin levels (as meas- The true value can be expected in the range from 6% to
ured by the LUMItestPCT®) too low, i.e. incorrectly. 72% with a probability of 95% (Table 2). The PCT-Q®

82 European Journal of Trauma 2003 · No. 2 © Urban & Vogel


Pelinka LE, et al. Quantitative vs Semiquantitative Procalcitonin Measurement

Tables 1a and 1b. Results by the LUMItestPCT® versus the PCT-Q® test. patients and the highly increased procalcitonin levels (>
The results counting each sample separately (a) were similar to the
2 ng/ml) found in systemic inflammatory response syn-
results weighted by the number of samples per patient (b).
drome.
a) Results counting each sample separately, LUMItestPCT® versus PCT-Q® The total number of samples measured by both tests
test (n = 167) is not identical with the total patient number
Increased Normal Total (n = 15). However, the study is focused upon the com-
LUMItestPCT® LUMItestPCT®
parison between two different tests in individual sam-
Increased PCT-Q® test 14 2 16
ples gained only from severely traumatized patients, i.e.,
Normal PCT-Q® test 24 127 151 from a comparable group. Thus, the number of samples
Total 38 129 167 measured by both tests in severely traumatized patients
is relevant, rather than the actual number of patients.
High procalcitonin levels were detected in 14 of 38 samples by the PCT-
Q® test. Normal procalcitonin levels were detected in 127 of 129 samples Since the total number of samples measured per patient
by the PCT-Q® test. varied, clustering of samples was taken into considera-
tion in the statistical analysis. At the increased procalci-
b) Results weighted by the number of samples per patient, LUMItestPCT®
versus PCT-Q® test tonin level (> 0.5 ng/ml), the total number of highly
Increased Normal Total
increased samples (> 2 ng/ml) was unfortunately very
LUMItestPCT® LUMItestPCT® small. Nevertheless, it should be pointed out that the
PCT-Q® test only picked up 36.8% of all increased pro-
Increased PCT-Q® test 1.8 0.3 2.1 calcitonin levels (50% of the highly and 34.4% of the
Normal PCT-Q® test 2.3 10.6 12.9 moderately increased procalcitonin levels). For the low
Total 4.1 10.9 15.0
procalcitonin category, it might have appeared reason-
To adjust for the different numbers of samples per patient, the values we- able to measure procalcitonin in healthy volunteers
re weighted by the reciprocal individual sample size. The results weighted using both the PCT-Q® test and the LUMItestPCT®.
by the number of samples per patient were similar to the results shown in
Table 1a, which counted each sample separately. However, we elected not to do so since the PCT-Q® test
is not sensitive enough to pick up procalcitonin in
Table 2. Sensitivity (44%) and specificity (97%) of the PCT-Q® test com- healthy volunteers.
pared to the LUMItestPCT® with raw (Raw CI) and simultaneous 95% Apart from the fact that the PCT-Q® test is semi-
confidence intervals (Sim CI). quantitative and immunochromatographic while the
LUMItestPCT® is quantitative and immunoluminomet-
Parameter Raw CI Sim CI
ric, there are principal differences between the two
Sensitivity (%) 44 8–69 6–72 tests, both with regard to cost and to handling. In theo-
Specificity (%) 97 90–100 89–100 ry, the LUMItestPCT® is roughly 25% cheaper per sin-
gle test than the PCT-Q® test. Furthermore, the
LUMItestPCT® takes twice as long to perform (1 h) as
test picked up normal procalcitonin levels in 127 (nor- the PCT-Q® test. In practice, however, the LUMItest-
mal LUMItestPCT® and normal PCT-Q® test) of 129 PCT® requires double measurements and standard
samples (Table 1a). The true value can be expected in curves as well as a luminometer. Furthermore, the
the range from 6% to 72% with a probability of 95% LUMItestPCT® requires experienced personnel since it
(Table 2). The specificity of the PCT-Q® test was 97%. is far more complicated to perform than the PCT-Q®
The true value can be expected in the range from 89% test. Thus, in practice, the LUMItestPCT® is only cheap-
to 100% with a probability of 95% (Table 2). The results er for laboratories with access to a luminometer and
weighted by the number of samples per patient (Table enough experienced personnel. Nevertheless, the PCT-
1b) were similar to the results counting each sample sep- Q® test, though quicker and very simple to perform, is
arately (Table 1a). also less accurate. We consider this lack of accuracy of
the PCT-Q® test a serious drawback in the trauma inten-
Discussion sive care unit.
The PCT-Q® test was less sensitive than the LUMItest Since the PCT-Q® test is highly specific, increased
PCT® at both the moderately increased procalcitonin procalcitonin readings can be considered reliable, i.e, it
levels (0.5–2 ng/ml) found in some multiple trauma is unlikely that the PCT-Q® test yields falsely increased

European Journal of Trauma 2003 · No. 2 © Urban & Vogel 83


Pelinka LE, et al. Quantitative vs Semiquantitative Procalcitonin Measurement

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time might be lost if incipient sepsis were overlooked or Correspondence Address
underestimated due to falsely normal procalcitonin Linda E. Pelinka, MD
readings. Ludwig Boltzmann Institute for
Experimental and Clinical Traumatology
Donaueschingenstraße 13
Acknowledgments 1200 Vienna
The authors wish to thank Anna Khadem, MTA, for technical assis- Austria
tance and are highly indebted to Heinz Petto, PhD, for valuable dis- Phone (+43/1) 33110-464, Fax -460
cussion and statistical evaluation. e-mail: lindapel@via.at

84 European Journal of Trauma 2003 · No. 2 © Urban & Vogel

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