ms_05056888003V10.

Elecsys BRAHMS PCT

Procalcitonin

Elecsys 2010
MODULAR ANALYTICS E170
05056888 003 100 cobas e 411
cobas e 601
cobas e 602

English R2 Anti-PCT-Ab~Ru(bpy) (black cap), 1 bottle, 9 mL:

Intended use Monoclonal anti-PCT antibody (mouse) labeled with ruthenium
Immunoassay for the in vitro quantitative determination of PCT complex 5.6 µg/mL; phosphate buffer 95 mmol/L, pH 7.5;
(procalcitonin) in human serum and plasma. preservative.
The Elecsys BRAHMS PCT assay can be used to aid in the early detection
of clinically relevant bacterial infections. PCT Cal1 PCT calibrator 1 (white cap), 1 bottle (lyophilized) for 4 mL:
The electrochemiluminescence immunoassay “ECLIA” is intended for use PCT (recombinant) approximately 0.10 ng/mL in a human
on Elecsys and cobas e immunoassay analyzers.
serum matrix; preservative.
Summary
Procalcitonin (PCT) is a 116 amino acid prohormone with a molecular PCT Cal2 PCT calibrator 2 (black cap), 1 bottle (lyophilized) for 4 mL:
weight of approximately 12.7 kD. PCT is expressed by neuroendocrine cells PCT (recombinant) approximately 54 ng/mL in a human
(C cells of the thyroid, pulmonary and pancreatic tissues) and successively serum matrix; preservative.
enzymatically cleaved into (immature) calcitonin, katacalcin, and an
N‑terminal region. The blood of healthy individuals contains only low levels PC PCT1 PreciControl PCT 1 (beige cap), 2 bottles (lyophilized) each
of PCT.1,2 It was discovered that PCT increases during bacterial infection. for 4 mL:
It is probable that multiple tissues express PCT throughout the body in PCT (recombinant) approximately 0.50 ng/mL in a human
response to sepsis as was shown in an animal model.3 PCT circulating in
septic patients consists of only 114 amino acids lacking the N-terminal serum matrix; preservative.
dipeptide Ala‑Pro.4 PC PCT2 PreciControl PCT 2 (brown cap), 2 bottles (lyophilized) each
Increased PCT levels are often found in patients suffering from bacterial for 4 mL:
sepsis, especially severe sepsis and septic shock.5,6,7,8,9,10 PCT is
considered as a prognostic marker to support outcome prediction in sepsis PCT (recombinant) approximately 10 ng/mL in a human
patients.8,11,12,13 serum matrix; preservative.
In acute pancreatitis PCT was found to be a reliable indicator of severity Calibrators: The exact lot‑specific calibrator values are encoded in the
and of major complications.14,15 barcoded labels of the test‑specific reagent.
In patients suffering from community-acquired respiratory tract infections or Controls: The exact lot‑specific target values and ranges are encoded in the
ventilator‑induced pneumonia PCT has been proposed as a guide for the barcodes as well as printed on the enclosed (or electronically available)
decision of antibiotic treatment necessity and to monitor treatment success. value sheet.
16,17
Precautions and warnings
Test principle For in vitro diagnostic use.
Sandwich principle. Total duration of assay: 18 minutes. Exercise the normal precautions required for handling all laboratory
▪ 1st incubation: Antigen in the sample (30 µL), a biotinylated monoclonal reagents.
PCT‑specific antibody, and a monoclonal PCT‑specific antibody labeled Disposal of all waste material should be in accordance with local guidelines.
with a ruthenium complexa) react to form a sandwich complex. Safety data sheet available for professional user on request.
All human material should be considered potentially infectious. All products
▪ 2nd incubation: After addition of streptavidin-coated microparticles, the derived from human blood are prepared exclusively from the blood of
complex becomes bound to the solid phase via interaction of biotin and donors tested individually and shown to be free from HBsAg and antibodies
streptavidin. to HCV and HIV. The testing methods applied were FDA-approved or
▪ The reaction mixture is aspirated into the measuring cell where the cleared in compliance with the European Directive 98/79/EC, Annex II,
microparticles are magnetically captured onto the surface of the List A.
electrode. Unbound substances are then removed with However, as no testing method can rule out the potential risk of infection
ProCell/ProCell M. Application of a voltage to the electrode then induces with absolute certainty, the material should be handled with the same level
chemiluminescent emission which is measured by a photomultiplier. of care as a patient specimen. In the event of exposure, the directives of the
▪ Results are determined via a calibration curve which is instrument- responsible health authorities should be followed.18,19
specifically generated by 2‑point calibration and a master curve provided Avoid foam formation in all reagents and sample types (specimens,
via the reagent barcode. calibrators and controls).
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
Reagent handling
Reagents - working solutions The reagents in the kit (M, R1 and R2) are ready for use and are supplied in
The reagent rackpack (M, R1, R2) is labeled as PCT. bottles compatible with the system.
M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Calibrators and controls
Carefully dissolve the contents of one bottle by adding exactly 4 mL of
Streptavidin-coated microparticles 0.72 mg/mL; preservative. distilled or deionized water and allow to stand closed for 15 minutes to
R1 Anti-PCT-Ab~biotin (gray cap), 1 bottle, 9 mL: reconstitute. Mix carefully, avoiding foam formation. Transfer the
reconstituted calibrators/controls into empty labeled snap‑cap bottles.
Biotinylated monoclonal anti-PCT antibody (mouse) 2.0 µg/mL;
Unless the entire volume is necessary for calibration and quality control on
phosphate buffer 95 mmol/L, pH 7.5; preservative. the analyzer, transfer aliquots of the freshly reconstituted calibrators and
controls into empty snap‑cap bottles (CalSet Vials/ControlSet Vials). Attach
the supplied labels to these additional bottles. Store the aliquots at -20 °C
for later use. Perform only one calibration or control procedure per aliquot.
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Procalcitonin

Note: Do not combine bottles from different lots. Use only control bottles out Materials required (but not provided)
of one lot with each other. ▪  11776576322, CalSet Vials, 2 x 56 empty snap‑cap bottles
All information required for correct operation is read in from the respective
reagent barcodes. ▪  03142949122, ControlSet Vials, 2 x 56 empty snap‑cap bottles
Please note: Both the vial labels, and the additional labels (if available) ▪ General laboratory equipment
contain 2 different barcodes. The barcode between the yellow markers is ▪ Elecsys 2010, MODULAR ANALYTICS E170 or cobas e analyzer
for cobas 8000 systems only. If using a cobas 8000 system, please turn Accessories for Elecsys 2010 and cobas e 411 analyzers:
the vial cap 180° into the correct position so the barcode can be read by the
system. Place the vial on the instrument as usual. ▪  11662988122, ProCell, 6 x 380 mL system buffer
Storage and stability ▪  11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
Store at 2‑8 °C. solution
Do not freeze. ▪  11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
Store the Elecsys reagent kit upright in order to ensure complete ▪  11933159001, Adapter for SysClean
availability of the microparticles during automatic mixing prior to use. ▪  11706802001, Elecsys 2010 AssayCup, 60 x 60 reaction vessels
Stability of the reagent rackpack ▪  11706799001, Elecsys 2010 AssayTip, 30 x 120 pipette tips
Accessories for MODULAR ANALYTICS E170, cobas e 601 and
unopened at 2-8 °C up to the stated expiration date cobas e 602 analyzers:
after opening at 2-8 °C 12 weeks ▪  04880340190, ProCell M, 2 x 2 L system buffer
on the analyzers 4 weeks ▪  04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
solution
Stability of the calibrators and controls
▪  03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
lyophilized calibrators/controls up to the stated expiration date CleanCell M before use
reconstituted calibrators/controls on 2 hours (use only once) ▪  03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
the analyzers finalization and rinsing during reagent change
reconstituted calibrators/controls at 3 months (freeze only once) ▪  12102137001, AssayTip/AssayCup Combimagazine M,
48 magazines x 84 reaction vessels or pipette tips, waste bags
-20 °C
▪  03023150001, WasteLiner, waste bags
Store the calibrators and controls upright in order to prevent the solution
from adhering to the snap‑cap. ▪  03027651001, SysClean Adapter M
Accessories for all analyzers:
Specimen collection and preparation
Only the specimens listed below were tested in a sufficient number and ▪  11298500316, Elecsys SysClean, 5 x 100 mL system cleaning
found acceptable. solution
Serum collected using standard sampling tubes or tubes containing Assay
separating gel. For optimum performance of the assay follow the directions given in this
Li‑heparin and K3‑EDTA plasma. document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions.
Criterion: Slope 0.9-1.1 + intercept within < ± 2 x analytical sensitivity (LDL)
+ coefficient of correlation > 0.95. Resuspension of the microparticles takes place automatically prior to use.
Read in the test‑specific parameters via the reagent barcode. If in
Stable for 24 hours at 2‑8 °C, 3 months at -20 °C. Freeze only once. exceptional cases the barcode cannot be read, enter the 15‑digit sequence
After drawing the blood, measure samples within 24 hours or freeze at of numbers.
-20 °C. Bring the cooled reagents to approximately 20 °C and place on the reagent
Frozen samples can lead to a lower recovery of up to 8 %. disk (20 °C) of the analyzer. Avoid foam formation. The system
The sample types listed were tested with a selection of sample collection automatically regulates the temperature of the reagents and the
tubes that were commercially available at the time of testing, i.e. not all opening/closing of the bottles.
available tubes of all manufacturers were tested. Sample collection systems Place the reconstituted calibrators (in the system-compatible bottles with
from various manufacturers may contain differing materials which could barcoded labels) in the sample zone.
affect the test results in some cases. When processing samples in primary All the information necessary for calibrating the assay is automatically read
tubes (sample collection systems), follow the instructions of the tube into the analyzer.
manufacturer.
After calibration has been performed, discard the calibrators.
Centrifuge samples containing precipitates before performing the assay.
Analyze the controls PC PCT1 and PC PCT2. The information on the
Do not use samples and controls stabilized with azide. barcoded label of the control serum bottle is read in automatically. After the
Ensure the samples, calibrators and controls are at 20‑25 °C prior to control procedure has been performed, discard the controls.
measurement.
Calibration
Due to possible evaporation effects, samples, calibrators and controls on Traceability: This method has been standardized against the BRAHMS PCT
the analyzers should be analyzed/measured within 2 hours. LIA assay.
Materials provided Every Elecsys BRAHMS PCT reagent set has a barcoded label containing
See “Reagents – working solutions” section for reagents. specific information for calibration of the particular reagent lot. The
predefined master curve is adapted to the analyzer using PCT Cal1 and
▪ 2 barcode cards PCT Cal2.
▪ control barcode sheet Calibrator sequence on all systems: Always measure PCT Cal2 before
▪ 2 x 8 bottle labels (calibrators) PCT Cal1.
▪ 2 x 14 bottle labels (controls) Calibration frequency: Calibration must be performed once per reagent lot
using fresh reagent (i.e. not more than 24 hours since the reagent kit was
▪ 6 empty labeled snap-cap bottles registered on the analyzer). Renewed calibration is recommended as
follows:

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Procalcitonin

▪ after 8 weeks when using the same reagent lot Dilution

▪ after 7 days (when using the same reagent kit on the analyzer) Samples with PCT concentrations above the measuring range can be
diluted manually with PCT negative human serum or plasma. The
▪ as required: e.g. quality control findings outside the defined limits recommended dilution is 1:4. The concentration of the diluted sample must
Quality control be > 1.0 ng/mL. After manual dilution, multiply the result by the dilution
For quality control, use PC PCT 1 and PC PCT 2. factor.
In addition, other suitable control material can be used. Expected values
Controls for the various concentration ranges should be run individually at Reference range
least once every 24 hours when the test is in use, once per reagent kit, and A study performed with the Elecsys BRAHMS PCT assay using 492
following each calibration. samples from apparently healthy males (245) and females (247) revealed
The control intervals and limits should be adapted to each laboratory’s the following normal value: 0.046 ng/mL (95th percentile).
individual requirements. Values obtained should fall within the defined Clinical cut-off
limits. Each laboratory should establish corrective measures to be taken if Results obtained with the Elecsys BRAHMS PCT assay are in agreement
values fall outside the defined limits. with the literature.20 A study performed on samples from patients admitted
Follow the applicable government regulations and local guidelines for to an ICU (intensive care unit) showed that PCT values:
quality control. < 0.5 ng/mL represent a low risk of severe sepsis and/or septic shock
Note: When using two reagent kits with different lots in the same run, the > 2.0 ng/mL represent a high risk of severe sepsis and/or septic shock
controls will be measured with both reagent lots. Use only control values
measured with the corresponding lots. Each laboratory should investigate the transferability of the expected values
to its own patient population and if necessary determine its own reference
Calculation ranges.
The analyzer automatically calculates the analyte concentration of each
sample in ng/mL. Clinical performance
Clinical studies were conducted on samples from 283 ICU patients. The
Limitations - interference patients were classified into categories based on the ACCP/SCCM
The assay is unaffected by icterus (bilirubin < 428 µmol/L or < 25 mg/dL), (American College of Chest Physicians/Society of Critical Care Medicine)
hemolysis (Hb < 0.559 mmol/L or < 0.900 g/dL), lipemia (Intralipid consensus criteria on their first day of ICU admission: SIRS (systemic
< 1500 mg/dL) and biotin (< 123 nmol/L or < 30 ng/mL). inflammatory response syndrome), sepsis, severe sepsis and septic shock.
22
Criterion: Recovery within ± 15 % of initial value.
Samples should not be taken from patients receiving therapy with high The PCT values of the patients with SIRS (n = 95) or sepsis (n = 71)
biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin compared to patients with severe sepsis (n = 60) or septic shock (n = 57)
administration. were as follows:
No interference was observed from rheumatoid factors up to a Results with a cut-off at 0.5 ng/mL
concentration of 1500 IU/mL.
Clinical classification
There is no high‑dose hook effect at PCT concentrations up to 1000 ng/mL.
Elecsys BRAHMS PCT SIRS Severe sepsis/ Total
In vitro tests were performed on 18 commonly used and 10 special
pharmaceuticals. No interference with the assay was found. septic shock
In rare cases, interference due to extremely high titers of antibodies to < 0.5 ng/mL 63 5 68
analyte‑specific antibodies, streptavidin or ruthenium can occur. These ≥ 0.5 ng/mL 32 112 144
effects are minimized by suitable test design.
PCT levels can be increased in certain situations without infectious origin. Total 95 117 212
These include, but are not limited to:20 Based on the above data the sensitivity was 96 %, the specificity 66 %, the
▪ prolonged or severe cardiogenic shock positive predictive value 78 % and the negative predictive value 93 %.
▪ prolonged severe organ perfusion anomalies Clinical classification
▪ small cell lung cancer or medullary C‑cell carcinoma of the thyroid Elecsys BRAHMS PCT SIRS Sepsis Total
▪ early after major trauma, major surgical intervention, severe burns < 0.5 ng/mL 63 25 88
▪ treatments which stimulate the release of pro‑inflammatory cytokines
≥ 0.5 ng/mL 32 46 78
▪ neonates (< 48 h after birth)21
Total 95 71 166
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other Based on the above data the sensitivity was 65 %, the specificity 66 %, the
findings. positive predictive value 59 % and the negative predictive value 72 %.
Limits and ranges Results with a cut‑off at 2 ng/mL
Measuring range
Clinical classification
0.02-100 ng/mL (defined by the lower detection limit and the maximum of
the master curve). Values below the lower detection limit are reported as Elecsys BRAHMS PCT SIRS Severe sepsis/ Total
< 0.02 ng/mL. Values above the measuring range are reported as septic shock
> 100 ng/mL. < 2 ng/mL 88 18 106
Lower limits of measurement
≥ 2 ng/mL 7 99 106
Lower detection limit of the test
Lower detection limit: ≤ 0.02 ng/mL Total 95 117 212
The lower detection limit represents the lowest measurable analyte level Based on the above data the sensitivity was 85 %, the specificity 93 %, the
that can be distinguished from zero. It is calculated as the value lying two positive predictive value 93 % and the negative predictive value 82 %.
standard deviations above that of the lowest standard (master calibrator,
standard 1 + 2 SD, repeatability study, n = 21).

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Clinical classification Analytical specificity

Elecsys BRAHMS PCT SIRS Sepsis Total The Elecsys BRAHMS PCT assay does not show any significant cross
reactions with the following substances, tested with PCT concentrations of
< 2 ng/mL 88 55 143 approx. 0.4 ng/mL and 1.5 ng/mL (max. tested concentration):
≥ 2 ng/mL 7 16 23 Substances Non-interfering concentrations (ng/mL)
Total 95 71 166 Human katacalcin 30
Based on the above data the sensitivity was 23 %, the specificity 93 %, the Human calcitonin 10
positive predictive value 70 % and the negative predictive value 62 %.
Human alpha-CGRPb) 10000
Specific performance data
Representative performance data on the analyzers are given below. Human beta-CGRP 10000
Results obtained in individual laboratories may differ. b) Calcitonin Gene-Related Peptide
Precision Functional sensitivity
Precision was determined using Elecsys reagents, pooled human ≤ 0.06 ng/mL
serum/plasma and controls in a protocol (EP5‑A2) of the CLSI (Clinical and The functional sensitivity is the lowest analyte concentration that can be
Laboratory Standards Institute): 2 runs per day in duplication each for reproducibly measured with an intermediate precision CV of 20 %.
21 days (n = 84). The following results were obtained:
Concordance with BRAHMS PCT LIA/BRAHMS PCT sensitive
Elecsys 2010 and cobas e 411 analyzers KRYPTOR
Repeatability Intermediate A comparison study was performed with the Elecsys BRAHMS PCT assay
precision and the BRAHMS PCT LIA. Cut-off values of 0.5 ng/mL and 2 ng/mL have
been evaluated.
Sample Mean SD CV SD CV
ng/mL ng/mL % ng/mL % BRAHMS PCT LIA
Human plasma 1 0.060 0.005 8.8 0.010 16.3 Elecsys BRAHMS PCT < 0.5 ng/mL ≥ 0.5 ng/mL Total
Human plasma 2 0.622 0.013 2.1 0.026 4.2 < 0.5 ng/mL 104 49 153
Human plasma 3 41.2 0.879 2.1 2.02 4.9 ≥ 0.5 ng/mL 6 370 376
PreciControl PCT1 0.520 0.007 1.3 0.019 3.7 Total 110 419 529
PreciControl PCT2 10.2 0.096 0.9 0.404 4.0 BRAHMS PCT LIA
MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers Elecsys BRAHMS PCT < 2 ng/mL ≥ 2 ng/mL Total
Repeatability Intermediate < 2 ng/mL 266 10 276
precision ≥ 2 ng/mL 11 242 253
Sample Mean SD CV SD CV Total 277 252 529
ng/mL ng/mL % ng/mL % The concordance between both assays was 90 % at the cut-off value of
Human serum 1 0.080 0.006 7.1 0.007 8.7 0.5 ng/mL and 96 % at the cutoff-value of 2 ng/mL.
Human serum 2 0.431 0.008 1.8 0.011 2.6 The Elecsys BRAHMS PCT assay was also compared to the BRAHMS
PCT sensitive KRYPTOR. Cut-off values of 0.5 ng/mL and 2 ng/mL have
Human serum 3 54.4 0.618 1.1 0.895 1.6 been evaluated.
PreciControl PCT1 0.491 0.013 2.6 0.016 3.2 BRAHMS PCT sensitive KRYPTOR
PreciControl PCT2 9.59 0.181 1.9 0.222 2.3 Elecsys BRAHMS PCT < 0.5 ng/mL ≥ 0.5 ng/mL Total
Method comparison < 0.5 ng/mL 183 20 203
A comparison of the Elecsys BRAHMS PCT assay (y) with the BRAHMS ≥ 0.5 ng/mL 2 392 394
PCT LIA (x) using human heparin plasma gave the following correlations
(ng/mL): Total 185 412 597
Number of samples measured: 152
BRAHMS PCT sensitive KRYPTOR
Passing/Bablok23 Linear regression
Elecsys BRAHMS PCT < 2 ng/mL ≥ 2 ng/mL Total
y = 1.065x - 0.090 y = 1.143x - 0.194
< 2 ng/mL 312 24 336
τ = 0.856 r = 0.981
≥ 2 ng/mL 1 260 261
The sample concentrations were between approximately 0.3 and
approximately 82 ng/mL. Total 313 284 597
A comparison of the Elecsys BRAHMS PCT assay (y) with the BRAHMS The concordance between both assays was 96 % at the cut-off value of
PCT sensitive KRYPTOR (x) using human heparin plasma gave the 0.5 ng/mL and 96 % at the cutoff-value of 2 ng/mL.
following correlations (ng/mL): References
Number of samples measured: 185 1 Gendrel D, Bohuon C. Procalcitonin as a marker of bacterial infection.
Pediatr Infect Dis J 2000;19:679-688.
Passing/Bablok23 Linear regression
2 Becker KL, Nylén ES, White JC, et al. Procalcitonin and the Calcitonin
y = 0.850x - 0.035 y = 1.090x - 0.709 Gene Family of Peptides in Inflammation, Infection, and Sepsis: A
τ = 0.953 r = 0.988 Journey from Calcitonin Back to Its Precursors. J Clin Endocrinol Metab
2004;89(4):1512-1525.
The sample concentrations were between approximately 0.04 and
approximately 85 ng/mL.

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3 Müller B, White JC, Nylén ES, et al. Ubiquitous Expression of the This product may not be used by purchaser to conduct any Point-of-Care
Calcitonin-I Gene in Multiple Tissues in Response to Sepsis. J Clin testing including but not limited to any near patient testing on hospital wards
Endocrinol Metab 2001;86(1):396-404. and/or emergency departments and/or in doctor’s offices and/or in any
4 Weglöhner W, Struck J, Fischer-Schulz C, et al. Isolation and other locations outside private or public clinical laboratories. No general
characterization of serum procalcitonin from patients with sepsis. patent or other license of any kind other than this specific right of use from
Peptides 2001;22:2099-2103. purchase is granted hereby.
For further information, please refer to the appropriate operator’s manual for
5 Gaïni S, Koldkjær OG, Mǿller HJ, et al. A comparison of high-mobility the analyzer concerned, the respective application sheets, the product
group-box 1 protein, lipopolysaccharide-binding protein and information and the Method Sheets of all necessary components (if
procalcitonin in severe community-aquired infections and bacteraemia: available in your country).
a prospective study. Crit Care 2007;11(4):77-87.
A point (period/stop) is always used in this Method Sheet as the decimal
6 Castelli GP, Pognani C, Cita M, et al. Procalcitonin, C-reactive protein, separator to mark the border between the integral and the fractional parts of
white blood cells and SOFA score in ICU: diagnosis and monitoring of a decimal numeral. Separators for thousands are not used.
sepsis. Minerva Anestesiol 2006;72:69-80.
Reagent developed in collaboration with B·R·A·H·M·S.
7 Gaïni S, Koldkjær OG, Pedersen C, et al. Procalcitonin,
lipopolysaccharide-binding protein, interleukin-6, and C-reactive protein B·R·A·H·M·S PCT is a registered trademark of BRAHMS Aktiengesellschaft.
in community-acquired infections and sepsis: a prospective study. Crit
Care 2006;10(2):53-63.
8 Clec’h C, Ferriere F, Karoubi P, et al. Diagnostic and prognostic value
of procalcitonin in patients with septic shock. Crit Care Med
2004;32(5):1166-1169. Symbols
9 Rey C, Los Arcos M, Concha A, et al. Procalcitonin and C-reactive Roche Diagnostics uses the following symbols and signs in addition to
protein as markers of systemic inflammatory response syndrome in those listed in the ISO 15223‑1 standard.
critically ill children. Intensive Care Med 2007;33:477-484.
10 Andreola B, Bressan S, Callegaro S, et al. Procalcitonin and C- Contents of kit
Reactive Protein as Diagnsotic Markers of Severe Bacterial Infections Analyzers/Instruments on which reagents can be used
in Febrile Infants and Children in the Emergency Department. Pediatr
Infect Dis J 2007;26(8):672-677. Reagent
11 Novotny A, Emmanuel K, Matevossian E, et al. Use of procalcitonin for Calibrator
early prediction of lethal outcome of postoperative sepsis. The
American Journal of Surgery 2007;194:35-39. Volume after reconstitution or mixing
12 Hausfater P, Juillien G, Madonna-Py B, et al. Serum procalcitonin COBAS, COBAS E, ELECSYS, MODULAR and PRECICONTROL are trademarks of Roche. INTRALIPID is a
measurement as diagnostic and prognostic marker in febrile adult trademark of Fresenius Kabi AB.
patients presenting to the emergency department. Crit Care All other product names and trademarks are the property of their respective owners.
2007;11(3):60-69. Significant additions or changes are indicated by a change bar in the margin.
13 Dahaba AA, Hagara B, Fall A, et al. Procalcitonin for early prediction of © 2014, Roche Diagnostics
survival outcome in postoperative critically ill patients with severe
sepsis. Br J Anaesth 2006;97:503-508.
14 Rau B, Schilling MK, Beger HG. Laboratory Markers of Severe Acute
Pancreatitis. Dig Dis 2004;22:247-257. Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
www.roche.com
15 Sato N, Endo S, Kasai T, et al. Relationship of the serum procalcitonin
level with the severity of acute pancreatitis. Research Communications
in Molecular Pathology and Pharmacology 2004;115,116:243-249.
16 Stolz D, Christ-Crain M, Gencay MM, et al. Diagnostic value of signs,
symptoms and laboratory values in lower respiratory tract infection.
Swiss Med Wkly 2006;136:434-440.
17 Christ-Crain M, Müller B. Biomarkers in respiratory tract infections:
diagnostic guides to antibiotic prescription, prognostic markers and
mediators. Eur Respir J 2007;30:556-573.
18 Occupational Safety and Health Standards: bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
19 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
20 Meisner M. Procalcitonin (PCT) – A new innovative infection parameter.
Biochemical and clinical aspects. Thieme Stuttgart, New York 2000,
ISBN: 3-13-105503-0.
21 Chiesa C, Panero A, Rossi N, et al. Reliability of Procalcitonin
Concentrations for the Diagnosis of Sepsis in Critically ill neonates. Clin
Infect Dis 1998;26:664-672.
22 American College of Chest Physicians/Society of Critical Care Medicine
Definitions for sepsis and organ failure and guidelines for the use of
innovative therapies in sepsis. Crit Care Med 1992;20:864-874.
23 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
for method comparison studies in clinical chemistry, Part III.
J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

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