ADVIA Centaur ®

ADVIA Centaur ® XP
ADVIA Centaur ® XPT
Immunoassay Systems

Procalcitonin (PCT)

Current revision and date a Rev. F, 2015-06

Product Name ADVIA Centaur® BRAHMS Procalcitonin assay REF 10378883
Systems ADVIA Centaur system
ADVIA Centaur XP system
ADVIA Centaur XPT system
Materials Required but Not ADVIA Centaur BRAHMS PCT Quality Control Material REF 10378884
Provided
ADVIA Centaur Wash 1 (2 x 1500 mL) REF 01137199

ADVIA Centaur Wash 1 (2 x 2500 mL) REF 03773025

Specimen Types Serum, lithium-heparinized or sodium-heparinized
plasma, EDTA plasma
Assay Range 0.02–75 ng/mL
Reagent Storage 2–8°C
Reagent On-System Stability 60 days
a In Rev. B or later, a vertical bar in the margin indicates a technical update to the previous version.

Intended Use
The ADVIA Centaur® BRAHMS PCT (Procalcitonin) assay is for in vitro diagnostic use in the
quantitative measurement of procalcitonin in human serum and plasma using the
ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. This assay is not intended
for use on any other system.
The ADVIA Centaur BRAHMS PCT assay is indicated, in conjunction with other laboratory
findings and clinical assessments, as an aid in the risk assessment of critically ill patients on their
first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock.

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Summary and Explanation

Severe sepsis and septic shock are among the leading causes of death in critically ill patients in
the ICU. The economic burden of this disease is tremendous. In 2001, a study in the United
States (US) estimated the average cost per patient to be $US 22,100 with an average stay of
19.6 days in the ICU, for a total annual cost estimated at $16.7 Billion.1
Despite great efforts to understand the underlying pathophysiology and to improve
therapeutic concepts, the mortality rate of sepsis remains high at 30–50% and up to 80%
mortality from septic shock.2
In the US, about 750,000 patients per year suffer from sepsis, causing an estimated
215,000 deaths per year, or over 500 per day. As the general population ages and technology
supports and prolongs longevity, the frequency of sepsis is expected to increase at a rate of
approximately 1.5% per year.1 According to an epidemiological study conducted by Emory
University School of Medicine and Centers for Disease Control and Prevention, sepsis rates in
the US increased by over 300% between 1979 and 2000. This is also due in part to the
over-prescribing of antibiotics and the emergence of antibiotic-resistant strains of common
bacteria.3
Early diagnosis and treatment of sepsis is associated with better patient outcomes.4
Procalcitonin (PCT) is a 116-amino acid peptide that shares a common structure with the
pro-hormone of calcitonin. Under normal metabolic conditions, calcitonin pro-hormone is
produced by the thyroid’s C-cells, where it undergoes proteolysis to yield the hormone
calcitonin. Calcitonin is then involved in calcium homeostasis. Under normal conditions,
plasma levels of the calcitonin pro-hormone have been shown to be under 0.1 ng/mL.5,6
However, during episodes of severe bacterial infection and sepsis, the level of blood-circulating
PCT increases to levels generally above 2 ng/mL, and sometimes to levels well above
500 ng/mL.7 In response to pro-inflammatory stimuli, such as bacterial infection, operation, or
trauma, PCT can be produced by nearly every tissue of the body.
Assicot, et al were among the first to report an increase of PCT levels at the onset of bacterial
infection. They also observed that PCT levels were correlated with the severity of the
infection.8 PCT immunoassays have been widely studied since these initial findings, and the
ability of PCT to aid in the diagnosis of severe sepsis has been well recognized.

Principles of the Procedure

The ADVIA Centaur BRAHMS PCT assay is a one-pass, 20-minute antibody sandwich
immunoassay in which the Solid Phase contains monoclonal antibody to fluorescein covalently
linked to paramagnetic particles. The Ancillary Reagent contains two antibodies to
procalcitonin labeled with fluorescein.

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Reagents
Reagent Description Storage Reagent Stability
ADVIA Centaur 5.0 mL/reagent pack 2–8°C Unopened: Stable until the
BRAHMS PCT anti-PCT (monoclonal mouse) antibody expiration date on the
ReadyPack® (~0.5 µg/mL) labeled with acridinium ester in carton
primary reagent protein buffer with bovine serum albumin On-system: 60 days
pack; (BSA), surfactant, and preservatives
Lite Reagent
ADVIA Centaur 10.0 mL/reagent pack 2–8°C Unopened: Stable until the
BRAHMS PCT anti-fluorescein (mono-clonal mouse)-coated expiration date on the
ReadyPack paramagnetic particles (PMP) (~0.15 mg/mL) carton
primary reagent in buffer with surfactant and preservatives On-system: 60 days
pack;
Solid Phase
Reagent
ADVIA Centaur 5.0 mL/reagent pack 2–8°C Unopened: Stable until the
BRAHMS PCT anti-PCT (monoclonal mouse) antibody expiration date on the
ReadyPack (~13.3 µg/mL) labeled with fluorescein in carton
ancillary reagent protein buffer with BSA, surfactant, and On-system: 60 days
pack; preservatives
Ancillary
Reagent

ADVIA Centaur 2.0 mL/vial 2–8°C Unopened: (Lyophilized)

BRAHMS PCT lyophilized, recombinant PCT in equine serum Stable until the expiration
Calibrator with preservatives date on the vial
Reconstituted: 24 hours
On-system: 8 hours

≤ -20°C Reconstituted: 42 days;

freeze-thaw 5 times

ADVIA Centaur 1500 mL/pack 2–25°C Unopened: Stable until the

Wash 1a phosphate-buffered saline with sodium azide expiration date on the pack
(< 0.1%) and surfactant On-system: 1 month

ADVIA Centaur 2500 mL/pack 2–25°C Unopened: Stable until the

Wash 1a phosphate-buffered saline with sodium azide expiration date on the pack
(< 0.1%) and surfactant On-system: 1 month

ADVIA Centaur 25.0 mL/reagent pack 2–8°C Unopened: Until the

ReadyPack equine serum with sodium azide (0.1%) and expiration date on the pack
ancillary reagent preservatives On-system:
pack; 28 consecutive days after
Multi-Diluent 1b accessing the ancillary
reagent pack
a See Materials Required but Not Provided
b See Optional Materials

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Warnings and Precautions

Safety data sheets (MSDS/SDS) available on [Link]/diagnostics.

CAUTION
This device contains material of animal origin and should be handled as a potential carrier and
transmitter of disease.

Contains sodium azide as a preservative. Sodium azide can react with copper or lead plumbing
to form explosive metal azides. On disposal, flush reagents with a large volume of water to
prevent buildup of azides. Disposal into drain systems must be in compliance with prevailing
regulatory requirements.
H319, H315, H317 Warning!
P280, Causes serious eye irritation. Causes skin irritation. May cause an allergic skin
P305+P351+P338, reaction.
P501 Wear protective gloves/protective clothing/eye protection/face protection. IF IN
EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing. Dispose of contents and
container in accordance with all local, regional, and national regulations.
Contains: ProClin 300; ADVIA Centaur BRAHMS PCT Calibrator

Dispose of hazardous or biologically contaminated materials according to the practices of your

institution. Discard all materials in a safe and acceptable manner and in compliance with
prevailing regulatory requirements.
For in vitro diagnostic use.

Preparing Reagents
All reagents are liquid and ready to use.
Mix all primary reagent packs by hand before loading them on the system. Visually inspect the
bottom of the reagent pack to ensure that all particles are dispersed and resuspended. For
detailed information about preparing the reagents for use, refer to the system operating
instructions.
Note
• Discard the primary reagent packs at the end of the on-system stability interval.
• Do not use reagents beyond the expiration date.

Storing and Stability

Store the reagents upright at 2–8°C.
Protect reagent packs from all heat and light sources. Reagent packs loaded on the system are
protected from light. Store unused reagent packs at 2–8°C away from heat and light sources.
All reagents are stable at 2–8°C until the expiration date on the packaging.

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Specimen Collection and Handling

Serum, lithium-heparinized or sodium-heparinized plasma, and EDTA plasma are the
recommended sample types for this assay.
The following recommendations for handling and storing blood samples are furnished by the
Clinical and Laboratory Standards Institute (CLSI), and augmented with additional sample
handling studies:9
• Collect all blood samples observing universal precautions for venipuncture.
• Allow serum to clot adequately before centrifugation.
• Keep tubes stoppered and upright at all times.
• Do not use samples that have been stored at room temperature for longer than 8 hours.
• Tightly cap and refrigerate specimens at 2–8°C if the assay is not completed within 8 hours.
• Freeze samples at or below -20°C if the sample is not assayed within 48 hours.
• Freeze samples up to five times, and mix thoroughly after thawing.
The purpose of handling and storage information is to provide guidance to users. It is the
responsibility of the individual laboratory to use all available references and/or its own studies
when establishing alternate stability criteria to meet specific needs.

Procedure
Materials Provided
The following materials are provided:

REF Contents Number of Tests

10378883 1 ReadyPack primary reagent pack containing ADVIA Centaur 100
BRAHMS PCT Lite Reagent and Solid Phase
1 ReadyPack Ancillary reagent pack containing Ancillary Reagent

ADVIA Centaur and ADVIA Centaur CP BRAHMS PCT

Master Curve card
1 vial of lyophilized ADVIA Centaur BRAHMS PCT low calibrator

1 vial of lyophilized ADVIA Centaur BRAHMS PCT high calibrator

Barcode labels for the calibrators

ADVIA Centaur and ADVIA Centaur CP BRAHMS PCT
Calibrator Assigned Value cards

Materials Required but Not Provided

The following materials are required to perform this assay, but are not provided:

Item Description
REF 10378884 ADVIA Centaur BRAHMS PCT 2 x 2 mL control 1
quality control material 2 x 2 mL control 2
Expected Value card
REF 01137199 ADVIA Centaur Wash 1 2 x 1500 mL/pack
(112351)
REF 03773025 ADVIA Centaur Wash 1 a 2 x 2500 mL/pack
a for use with systems with 2500 mL capacity

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Optional Materials
The following materials may be used to perform this assay, but are not provided:

Item Description
REF 07907174 ADVIA Centaur Multi-Diluent 1 6 ReadyPack ancillary reagent packs
(110313) containing 25 mL/pack
REF 07293184 ADVIA Centaur Multi-Diluent 1 2 ReadyPack ancillary reagent packs
(110312) containing 25 mL/pack

Assay Procedure
For detailed instructions on performing the procedure, refer to the system operating
instructions.
The system automatically performs the following actions:
• Dispenses 100 µL of sample into a cuvette and incubates for 15 seconds.
• Dispenses 45 µL of Ancillary Reagent and incubates for 5.75 minutes at 37°C.
• Dispenses 100 µL of Solid Phase and 50 µL of Lite Reagent and incubates for 18 minutes
at 37°C.
• Separates the Solid Phase from the mixture and aspirates the unbound reagent.
• Washes the cuvettes with Wash 1.
• Dispenses 300 µL each of Acid Reagent and Base Reagent to initiate the chemiluminescent
reaction.
A direct relationship exists between the amount of PCT present in the patient sample and the
amount of relative light units (RLUs) detected by the system.

Preparing the System

Ensure that the system has sufficient primary and ancillary reagent packs. For detailed
information about preparing the system, refer to the system operating instructions.
Load the ReadyPack reagent packs in the primary reagent area using the arrows as a placement
guide. The system automatically mixes the primary reagent packs to maintain homogeneous
suspension of the reagents. For detailed information about loading reagents, refer to the
system operating instructions.
If automatic dilution of a sample is required, load ADVIA Centaur Multi-Diluent 1 in the ancillary
reagent entry.

Preparing the Samples

This assay requires 100 µL of sample for a single determination. This volume does not include
the unusable volume in the sample container or the additional volume required when
performing duplicates or other tests on the same sample. For detailed information about
determining the minimum required volume, refer to the system operating instructions.
Before placing samples on the system, ensure that samples have the following characteristics:
• Samples are free of fibrin or other particulate matter.
• Samples are free of bubbles.

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On-System Stability
The ADVIA Centaur BRAHMS PCT assay reagents are stable unopened until the expiration date
on the carton or onboard the system for 60 days.

Performing Calibration
For calibration of the ADVIA Centaur BRAHMS PCT assay, use ADVIA Centaur BRAHMS PCT
Calibrators provided with each kit. The calibrators provided in this kit are matched to the
ReadyPack primary reagent pack.
Note The PCT Calibrators provided in this kit are matched to the Solid Phase, Lite Reagent,
and Ancillary Reagent. Do not mix PCT Calibrator lots with different lots of Solid Phase, Lite
Reagent, and Ancillary Reagent.

Preparing Calibrators
1. Add 2.0 mL of reagent water into each calibrator vial using a volumetric or precision pipet.
Note For information about reagent water, refer to the system operating instructions.
2. Let the calibrators stand for 15 to 20 minutes at room temperature (20° to 30°C) to allow
the lyophilized material to dissolve.
3. Gently swirl and invert the vials until homogeneous.
The calibrator can be aliquoted into sample cups that are sealed tightly. Freeze for up to
42 days and thaw up to five times. To ensure complete homogeneity, thawed calibrators must
be gently mixed and inverted.

Calibration Frequency
Calibrate the assay at the end of the 35-day calibration interval.
Additionally, the ADVIA Centaur BRAHMS PCT assay requires a two-point calibration:
• When changing lot numbers of primary reagent packs.
• When replacing system components.
• When quality control results are repeatedly out of range.

Using Barcode Labels

Note Calibrator barcode labels are lot-number specific. Do not use barcode labels from one
lot of calibrators with any other lot of calibrators.
Use the PCT Calibrator barcode labels to label the Low and High Calibrator sample cups when
performing the PCT assay. Place the barcode label on the sample cup so that the readable
characters on the side of the label are vertical on the sample cup.

Performing Master Curve Calibration

The ADVIA Centaur BRAHMS PCT assay requires a Master Curve calibration when using a new
lot number of Solid Phase, Lite Reagent, and Ancillary Reagent. For each new lot number of
Solid Phase, Lite Reagent, and Ancillary Reagent, use the barcode reader or keyboard to enter
the Master Curve values on the system. The Master Curve card contains the Master Curve
values. For detailed information about entering calibration values, refer to the system
operating instructions.

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Performing Quality Control

Follow government regulations or accreditation requirements for quality control frequency.
For detailed information about entering quality control values, refer to the system operating
instructions.
To monitor system performance and chart trends, as a minimum requirement, assay two levels
of quality control material on each day that samples are analyzed. Assay quality control
samples when performing a two-point calibration. Treat all quality control samples the same as
patient samples.
Siemens Healthcare Diagnostics recommends the use of commercially available quality control
materials with at least 2 levels (low and high). A satisfactory level of performance is achieved
when the analyte values obtained are within the Acceptable Control Range for the system or
within your range, as determined by an appropriate internal laboratory quality control scheme.

Taking Corrective Action

If the quality control results do not fall within the Expected Values or within the laboratory’s
established values, do not report results. Take the following actions:
• Verify that the materials are not expired.
• Verify that required maintenance was performed.
• Verify that the assay was performed according to the instructions for use.
• Rerun the assay with fresh quality control samples.
• If necessary, contact your local technical support provider or distributor for assistance.

Results
Effect of Ambient Temperature on Results
CAUTION
The operating range for the ADVIA Centaur BRAHMS PCT assay is 20–25°C (68–77°F).
Do not report results for the ADVIA Centaur BRAHMS PCT assay if your laboratory temperature is
below 20°C (68°F) or above 25°C (77°F). The ADVIA Centaur BRAHMS PCT assay is susceptible to
ambient temperature change, which has the potential to affect recoveries of patient samples and
controls. The recoveries of patient samples and control materials may change by ±2.6% for each
Celsius degree change in an ambient temperature range of 20–25°C (68–77°F).
Quality control results for this assay will reflect any temperature effects on assay results. To ensure
optimal assay performance, each laboratory should determine how often quality control material is
run based on the ambient temperature conditions for that laboratory.

Dilutions
The following information pertains to dilutions:
• Dilute and retest patient samples with PCT levels greater than 75 ng/mL to obtain
accurate results.
• For automatic dilutions, ensure that ADVIA Centaur Multi-Diluent 1 is loaded and set
the system parameters as follows:
Dilution point: ≥ 75 ng/mL
Dilution factor: 20
For detailed information about automatic dilutions, refer to the system operating
instructions.

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Interpretation of Results
Results of this assay should always be interpreted in conjunction with patient's medical history,
clinical presentation and other findings.

Limitations
The operating range for the ADVIA Centaur BRAHMS PCT assay is 20–25°C (68–77°F). Do not
report results for the ADVIA Centaur BRAHMS PCT assay if your laboratory temperature is below
20°C (68°F) or above 25°C (77°F).
Do not pour the calibrators back into the vials after calibration because evaporation could
occur, which may affect performance.
Dispose of any calibrator remaining in the sample cups after 8 hours.
Do not refill calibrator sample cups when the contents are depleted. If required, dispense fresh
calibrators.
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering
with in vitro immunoassays.10 Patients routinely exposed to animals or to animal serum
products can be prone to this interference and anomalous values may be observed. Additional
information may be required for diagnosis.
Do not use samples which contain fluorescein. Fluorescein levels greater than 0.10 μg/mL can
produce falsely reduced results in this assay. Evidence suggests that patients undergoing
retinal fluorescein angiography can retain amounts of fluorescein in the body for up to 48–72
hours post treatment. In the cases of patients with renal insufficiency, including many
diabetics, retention could be much longer. Such samples can produce falsely reduced values
when tested with this assay, and should not be tested.11, 12 Testing of samples spiked with a
theoretical maximum level of fluorescein (250 μg/mL) used in these patients have resulted in
procalcitonin levels < 0.2 ng/mL instead of the true value of 0.5 ng/mL.

Expected Values
In normal subjects, procalcitonin concentrations are < 0.1 ng/mL. In a population of 456
subjects (96 serum, 88 sodium-heparinized plasma, 190 lithium-heparinized plasma, and 82
EDTA plasma), 456 had procalcitonin values < 0.1 ng/mL. The 95% confidence interval for the
mean concentration is 0.023 to 0.028 ng/mL procalcitonin.

Performance Characteristics
Performance characteristics studies were performed on the ADVIA Centaur system.

Analytical Measuring Range

The ADVIA Centaur BRAHMS PCT assay measures procalciton concentrations from
0.02–75 ng/mL.

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Specificity
The following potential cross reactants were added to a human serum-based sample at the
concentrations indicated, and were evaluated for potential interference in the ADVIA Centaur
BRAHMS PCT assay. The results demonstrated a < 0.3% interference from each compound or
protein tested.

Cross-reactant Concentration Tested (ng/mL) Cross-reactivity (%)

Calcitonin-Human 8 -0.25
Calcitonin-Salmon 30 -0.03
Calcitonin-EeL 30 0.03
Xigris 144 0.00
α-CGRP 30 0.03
β-CGRP 30 0.00
Katacalcin 30 -0.20
Cefotaxim 900,000 0.00
Dobutamine 11,200 0.00
Dopamine 130,000 0.00
Furosemide 20,000 0.00
Heparin 40,000 0.00
Imipenem 1,180,000 0.00
Noradrenaline 2000 0.00
Vancomycin 3,500,000 0.00

Sensitivity
The ADVIA Centaur BRAHMS PCT assay measures PCT concentrations up to 75 ng/mL
with a limit of blank (LoB) concentration of 0.03 ng/mL. The limit of blank is defined as the
concentration of analyte that corresponds to the 95th percentile of the distribution of the
human negative basepool. The PCT human negative basepool was assayed 6 times using 2 lots
of reagents on 2 systems (n = 60) over a period of at least 5 days.
The Limit of Detection (LoD) is determined according to CLSI protocol EP17-A.13 Limit of
detection is defined as the lowest concentration of PCT that can be detected with 95%
probability. The LoD was determined by using low-level PCT samples that were assayed
6 times using 2 lots of reagents on 2 systems (n = 60) over a period of 5 days. The LoD was
determined to be 0.04 ng/mL.
The functional sensitivity is the lowest concentration at which the total imprecision for the
assay does not exceed 20%. The functional sensitivity of the ADVIA Centaur BRAHMS PCT assay
is < 0.05 ng/mL. Multiple samples in the range of 0.01 to 0.20 ng/mL were assayed 3 times in
each of at least 45 runs using 3 lots of reagents on 3 systems (n = 135) over a period of 5 days.

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Precision
Precision was evaluated according to the CLSI protocol EP5-A2.14 According to this protocol,
the assay was run 2 times per day, three replicates per run for 20 days (n = 120 per sample)
using the ADVIA Centaur BRAHMS PCT assay. The method was calibrated on the first run of
day one. The following results were obtained:

Mean Within Run (%CV) Between Run (%CV) Total (%CV)

0.20 4.3 8.5 9.8
0.28 2.6 3.7 5.1
0.33 1.9 4.2 5.1
0.50 2.1 4.4 5.3
0.97 1.5 2.1 3.4
1.81 1.6 7.7 7.9
3.95 1.6 8.5 8.6
7.53 2.1 7.6 7.9
65.94 1.5 7.2 7.4

Accuracy / Method Comparison

For 202 samples in the range of 0.05 to 80 ng/mL, the relationship between the ADVIA Centaur
BRAHMS PCT assay and the BRAHMS Kryptor assay is described by using Passing Bablok
regression:
ADVIA Centaur BRAHMS PCT = 0.95 (BRAHMS Kryptor) - 0.00 ng/mL
Correlation coefficient (r) = 0.99
ADVIA Centaur BRAHMS PCT

BRAHMS Kryptor PCT ng/mL

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Interferences

Serum specimens that are . . . Demonstrate ≤ 10% change in results . . .

hemolyzed Up to 500 mg/dL of hemoglobin
lipemic Up to 1000 mg/dL of triglycerides
icteric Up to 40 mg/dL of conjugated bilirubin
icteric Up to 40 mg/dL of unconjugated bilirubin
proteinemic As low as 3.5 g/dL of protein

Serum specimens that contain . . . Demonstrate ≤ 10% change in results . . .

biotin Up to 500 ng/mL
cholesterol Up to 400 mg/dL
fluorescein As low as 0.1 ug/mL
human immunoglobulin As low as 3.6 g/dL

High-Dose Hook Effect

High procalcitonin levels can cause a paradoxical decrease in the RLUs (high-dose hook effect).
In this assay, procalcitonin levels as high as 2000 ng/mL will assay greater than
75 ng/mL.

Standardization
An International PCT- Reference Preparation is not available. The ADVIA Centaur BRAHMS PCT
Assay is standardized using a reference preparation antigen as master standard. This highest
available standard is specified by BRAHMS with:
• N-terminal amino acid sequencing (Edmann’s method)
• Mass analysis
Assay standardization is verified through regression analysis of a PCT-positive patient
population.

Technical Assistance
For customer support, please contact your local technical support provider or distributor.
[Link]/diagnostics

References
1. Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of
severe sepsis in the United States: Analysis of incidence, outcome, and associated costs of
care. Crit Care Med. 2001; 29(7):1303-1310.
2. Brun-Buisson C. The epidemiology of the systemic inflammatory response. Intensive Care
Med. 2000;26(1):S64-74.
3. Martin GS, Mannino, DM. Eaton S, Moss M. The epidemiology of sepsis in the United States
from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54.
4. Yu DT, Black E, Sands KE, et al. Severe sepsis: variation in resource and therapeutic
modality use among academic centers. Crit Care Med. 2003;7:R24-R34.
5. Snider RH, Nylen ES, Becker KL. Procalcitonin and its component perptides in systemic
inflammation: immunochemical characterization. J Investig Med. 1997; 45(9):552-560.
6. BRAHMS PCT Sensitive KRYPTOR assay instruction manual. (ver. 2.0us)

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7. Harbarth S, Holeckova K, Froidevaux C, et al. Diagnostic value of procalcitonin, interleukin-

6, and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J Respir Crit
Care Med. 2001; 164:396-402.
8. Assicot M, Gendrel D, Carsin H, et al. High serum procalcitonin concentrations in patients
with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8.
9. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Handling
and Processing of Blood Specimens; Approved Guideline - Third Edition. Wayne, PA: Clinical
and Laboratory Standards Institute; 2004. NCCLS Document H18-A3.
10. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays.
Clin Chem. 1988;34:27–33.
11. Inloes R, Clark, D and Drobnies A: Interference of fluorescein, used in retinal angiography
with certain clinical laboratory tests. Clin Chem 1987, 33:2126–2127.
12. Fluorescein Novartis 500mg/5mL (fluorescein sodium) [product information]. North Ryde,
NSW: Novartis Pharmaceuticals Australia Pty Limited; 2012
13. Clinical and Laboratory Standards Institute (formerly NCCLS). Protocols for Determination
of Limits of Detection and Limits of Quantitation; Approved Guideline. Wayne, PA:
Clinical and Laboratory Standards Institute; 2004. CLSI Document EP17-A.
14. Clinical and Laboratory Standards Institute (formerly NCCLS). Evaluation of Precision
Performance of Quantitative Measurement Methods; Approved Guideline -
Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
NCCLS Document EP5-A2.

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Definition of Symbols
The following symbols may appear on the product labeling:

Symbol Definition Symbol Definition

In vitro diagnostic medical device Catalog number

Authorized Representative in
Legal manufacturer
the European Community

CE Mark with identification number

CE Mark
of notified body

Consult instructions for use Biological risk

Do not freeze (> 0°C) Temperature limitation

Lower limit of temperature Upper limit of temperature

Keep away from sunlight and heat Up

Use by Contains sufficient for (n) tests

Shake the reagent pack vigorously.

Refer to Preparing Reagents in the
Batch code assay-specific ADVIA Centaur
product instructions for detailed
information.

YYYY-MM-DD Date format (year-month-day) Rev. Revision

Variable hexadecimal number that

ensures the Master Curve and
Master Curve Definition
Calibrator definition values entered
are valid.

Lot Details Green dot

Recycle Printed with soy ink

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Trademarks
ADVIA Centaur and ReadyPack are trademarks of Siemens Healthcare Diagnostics.
Reagent developed in collaboration with .
PCT is a registered trademark of BRAHMS Aktiengesellschaft.
© 2014 Siemens Healthcare Diagnostics. All rights reserved.
US Pats 5,609,822; 5,788,928

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PCT ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT Systems

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