ADVIA Centaur ®

ADVIA Centaur ® XP
ADVIA Centaur ® XPT
Immunoassay Systems

CEA
Current revision and date a Rev. L, 2015-01
Product Name ADVIA Centaur® CEA assay (500 Tests) REF 09788458
(110762)
ADVIA Centaur CEA assay (100 Tests) REF 00937450
(110761)
Systems ADVIA Centaur system
ADVIA Centaur XP system
ADVIA Centaur XPT system
Materials Required but Not ADVIA Centaur Calibrator D (6 pack) REF 00133564
Provided (672183)
ADVIA Centaur Calibrator D (2 pack) REF 04956492
(672173)
Specimen Types Serum
Assay Range 0.5–100 ng/mL (µg/L)
Reagent Storage 2–8°C
Reagent On-System Stability 14 days
a In Rev. B or later, a vertical bar in the margin indicates a technical update to the previous version.

WARNING
The concentration of CEA in a given specimen, as determined by assays from different manufacturers,
can vary due to differences in assay methods and reagent specificity. The results reported by the
laboratory to the physician must include the identity of the CEA assay used. Values obtained with
different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the
assay method used for determining serial CEA levels is changed, the laboratory must perform additional
serial testing to confirm baseline values.
United States federal law restricts this device to sale and distribution by or on the order of a physician, or
to a clinical laboratory; and use is restricted to, by, or on the order of a physician.

Intended Use
For in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen (CEA)
in serum to aid in the management of cancer patients in whom changing concentrations of CEA
are observed using the ADVIA Centaur®, ADVIA Centaur XP, and ADVIA Centaur XPT systems.

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Summary and Explanation

Carcinoembryonic antigen is a glycoprotein normally found in embryonic entodermal
epithelium. In the mid-1960s, Gold and Freedman isolated CEA from extracts of malignant
tissue.1,2 CEA belongs to a group of tumor markers referred to as oncofetal proteins. Increased
serum CEA levels have been detected in persons with primary colorectal cancer1,2 and in
patients with other malignancies including gastrointestinal tract, breast, lung, ovarian,
prostatic, liver, and pancreatic cancers.1–5 Elevated serum CEA levels have also been detected
in patients with nonmalignant disease, especially patients who are older or who are
smokers.5,6 CEA levels are not useful in screening the general population for undetected
cancers. However, CEA levels provide important information about patient prognosis,
recurrence of tumors after surgical removal, and effectiveness of therapy.1–6
Serial CEA levels are useful in monitoring the course of disease. CEA levels generally fall to
normal or near normal levels within 1 to 4 months after surgical removal of cancerous tissue. A
rise in CEA levels may be the first indication of recurrence, and may precede physical signs and
symptoms.2,6,7 Serial CEA levels are also useful in assessing the effectiveness of chemotherapy
or radiation treatment. A sustained rise in CEA levels can indicate ineffective therapy or
possible metastasis.1–5, 7
CEA is a useful tool for monitoring and managing cancer therapy, and provides the clinician
with additional information about patient prognosis.

Principles of the Procedure

The ADVIA Centaur CEA assay is a two-site sandwich immunoassay using direct
chemiluminometric technology, which uses constant amounts of two antibodies. The first
antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-CEA antibody labeled with
acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-CEA
antibody covalently coupled to paramagnetic particles.

Reagents
Reagent Description Storage Reagent Stability
ADVIA Centaur 5.0 mL/reagent pack 2–8°C Unopened: Stable until the
CEA ReadyPack® polyclonal rabbit anti-CEA antibody expiration date on the carton
primary reagent (~400 ng/mL) labeled with acridinium ester in On-system: 14 days
pack; phosphate buffered saline with protein
Lite Reagent stabilizers, sodium azide (0.12%), and
preservatives
ADVIA Centaur 25.0 mL/reagent pack 2–8°C Unopened: Stable until the
CEA ReadyPack monoclonal mouse anti-CEA antibody expiration date on the carton
primary reagent (~120 µg/mL) covalently coupled to On-system: 14 days
pack; Solid paramagnetic particles in phosphate buffered
Phase Reagent saline with protein stabilizers, sodium azide
(0.11%), and preservatives
ADVIA Centaur 5.0 mL/reagent pack 2–8°C Unopened: Until the expiration
CEA ReadyPack bicine buffer, gelatin, and BSA with date on the pack
ancillary reagent preservatives and sodium azide (0.1%) On-system:
pack; 28 consecutive days after
CEA Diluent a accessing the ancillary reagent
pack
ADVIA Centaur 10.0 mL/reagent vial 2–8°C Unopened: Until the expiration
CEA Diluent a bicine buffer, gelatin, and BSA with date on the vial
preservatives and sodium azide (0.1%)
a 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 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.
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
For liquids: All reagents are liquid and ready to use.
Use this procedure to mix ADVIA Centaur CEA primary reagent packs that are unpierced.

CAUTION
Do not use this procedure for pierced ADVIA Centaur CEA reagent packs. Discard pierced ADVIA Centaur
CEA reagent packs that have been removed from the system.

1. Hold the reagent pack firmly with thumb on one side and fingers on the other side. Shake
vigorously for 15 seconds, using a back and forth motion.

15 sec.

2. Hold the reagent pack firmly at one end, with film side up, and tap sharply on a bench top
five times to reduce foaming caused by shaking.

x5

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Visually inspect the bottom of the reagent pack to ensure that all particles are dispersed and
resuspended.

CAUTION
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.

Specimen Collection and Handling

Serum is the recommended sample type for this assay.
Plasma samples should not be used because their performance in this assay has not been
determined.
The following recommendations for handling and storing blood samples are furnished by the
Clinical and Laboratory Standards Institute (CLSI): 8
• Collect all blood samples observing universal precautions for venipuncture.
• Allow samples 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 only once 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

09788458 5 ReadyPack primary reagent packs containing ADVIA Centaur 500
(110762) CEA Lite Reagent and Solid Phase
ADVIA Centaur CEA Master Curve card
00937450 1 ReadyPack primary reagent pack containing ADVIA Centaur 100
(110761) CEA Lite Reagent and Solid Phase
ADVIA Centaur CEA Master Curve card

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Materials Required but Not Provided

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

Item Description
REF 00133564 ADVIA Centaur Calibrator D 6 vials of low calibrator
(672183) 6 vials of high calibrator
REF 04956492 ADVIA Centaur Calibrator D 2 vials of low calibrator
(672173) 2 vials of high calibrator

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

Item Description
REF 07584944 ADVIA Centaur CEA Diluent 2 ReadyPack ancillary reagent packs
(110322) containing 5 mL/pack
REF 01989969 ADVIA Centaur CEA Diluent 10 mL/vial
(672255)
REF 672427 ADVIA Centaur CEA Master Curve Material 6 x 1 mL

Assay Procedure
For detailed instructions on performing the procedure, refer to the system operating
instructions.
The system automatically performs the following steps:
1. Dispenses 50 µL of sample into a cuvette.
2. Dispenses 50 µL of Lite Reagent and 250 µL of Solid Phase and incubates for 7.5 minutes
at 37°C.
3. Separates, aspirates, and washes the cuvettes with reagent water.
Note For information about reagent water, refer to the system operating instructions.
4. Dispenses 300 µL each of Acid Reagent and Base Reagent to initiate the chemiluminescent
reaction.
5. Reports results according to the selected option, as described in the system operating
instructions.

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 unpierced 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 CEA Diluent in the ancillary
reagent entry.

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Preparing the Samples

This assay requires 50 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, see the system operating instructions.
Note The sample volume required to perform onboard dilution differs from the sample
volume required to perform a single determination. For detailed information, refer to
Dilutions.
Before placing samples on the system, ensure that samples have the following characteristics:
• Samples are free of fibrin or other particulate matter. Remove particulates by
centrifugation at 1000 x g for 15–20 minutes.
• Samples are free of bubbles.

On-System Stability
The ADVIA Centaur CEA assay reagents are stable unopened until the expiration date on the
carton or onboard the system for 14 days.

Performing Calibration
For calibration of the ADVIA Centaur CEA assay, use the ADVIA Centaur Calibrator D. Perform
that calibration as described in the calibrator instructions for use.

Calibration Frequency
Calibrate the assay at the end of the 21-day calibration interval.
Additionally, the ADVIA Centaur CEA 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.

Performing Master Curve Calibration

The ADVIA Centaur CEA assay requires a Master Curve calibration when using a new lot
number of Lite Reagent and Solid Phase. For each new lot number of Lite Reagent and Solid
Phase, 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.

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, two levels of
quality control material should be assayed on each day that samples are analyzed. Quality
control samples should also be assayed 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.

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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
Calculation of Results
For detailed information about how the system calculates results, refer to the system operating
instructions.
The system reports serum CEA results in ng/mL (mass units) or µg/L (SI units), depending on
the units defined when setting up the assay. The conversion formula is 1 ng/mL = 1 µg/L.

Dilutions
The sample volume required to perform onboard dilution differs from the sample volume
required to perform a single determination. Refer to the following information for the sample
volume required to perform onboard dilutions:

Dilution Sample Volume (µL)

1:5 40
1:10 40
1:50 40
1:100 40

The following information pertains to dilutions:

• Serum samples with CEA levels greater than 100 ng/mL (µg/L) must be diluted and retested
to obtain accurate results.
• Patient samples can be automatically diluted by the system or prepared manually.
• For automatic dilutions, ensure that ADVIA Centaur CEA Diluent is loaded and set the
system parameters as follows:
Dilution point: ≤ 100 ng/mL (µg/L)
Dilution factor: 5, 10, 50, 100
For detailed information about automatic dilutions, refer to the system operating
instructions.
• Manually dilute the patient samples when patient results exceed the linearity of the assay
using automatic dilution, or when laboratory protocol requires manual dilution.
• Use CEA Diluent to manually dilute patient samples, and then load the diluted sample in
the sample rack, replacing the undiluted sample.
• Ensure that results are mathematically corrected for dilution. If a dilution factor is entered
when scheduling the test, the system automatically calculates the result.

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

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Limitations
WARNING
Do not use the ADVIA Centaur CEA immunoassay as a screening test for diagnosis.
Note
Do not interpret levels of CEA as absolute evidence of the presence or the absence of malignant disease.
Measurements of CEA should always be used in conjunction with other diagnostic procedures, including
information from the patient’s clinical evaluation.
The concentration of CEA in a given specimen determined with assays from different manufacturers can
vary due to differences in assay methods, calibration, and reagent specificity. CEA determined with
different manufacturers’ assays will vary depending on the method of standardization and antibody
specificity.

Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering
with in vitro immunoassays.9 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.

Expected Values
The expected results for the ACS:180® CEA assay were previously established. Data was
obtained as shown in the following table. Serum samples from healthy subjects and patients
with various malignant diseases were analyzed. The cancer patients included in this study
represented a variety of disease states from active, progressive malignancy to no clinical
evidence of disease. The frequency of positive CEA results was significantly lower in patients
with no evidence of active disease compared to those with active disease.

% Distribution of CEA (ng/mL) (µg/L)

Clinical Condition N 0–2.5 2.6–5.0 5.1–10.0 10.1–20 > 20.0

Healthy Subject
Nonsmokers 225 98.2 1.8 0 0 0
Smokers 150 87.3 8.0 4.7 0 0

Cancerous Diseases
Colorectal 250 37.6 10.8 7.2 6.4 38.0
Lung 158 46.2 15.8 10.8 7.0 20.2
Breast 221 68.3 14.9 7.7 2.3 6.8
Gastric 35 60.0 17.1 8.6 5.7 8.6
Ovarian 35 82.8 11.4 2.9 2.9 0
Pancreatic 43 44.2 20.9 16.3 7.0 11.6
Liver 6 50.0 16.7 0 33.3 0
Lymphoproliferative 15 80.0 20.0 0 0 0
Othera 41 75.0 10.0 10.0 5.0 0

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% Distribution of CEA (ng/mL) (µg/L)

Clinical Condition N 0–2.5 2.6–5.0 5.1–10.0 10.1–20 > 20.0

Nonmalignant Diseases
Cirrhosis 53 41.5 13.2 32.1 13.2 0
Other benign liver 5 40.0 20.0 0 40.0 0
Ulcerative colitis 11 90.9 9.1 0 0 0
Benign polyps 23 65.2 21.8 13.0 0 0
Colon and intestinal 15 66.7 20.0 0 13.3 0
Gastrointestinal 21 76.2 14.2 0 4.8 4.8
Breast 53 96.2 0 1.9 0 1.9
Kidney and bladder 12 83.4 8.3 0 8.3 0
Lung 29 69.0 24.1 6.9 0 0
Otherb 117 86.3 8.5 4.3 0.9 0
a Other cancers includes bladder, prostate, esophagus, head and neck, sarcoma, and kidney.
b Other includes benign uterine, cervical and vaginal, benign ovary, and benign male genital as well as
other benign conditions.

These results were confirmed for the ADVIA Centaur CEA assay by analyzing 284 samples in the
range of 0.5 to 78.5 ng/mL (µg/L). Refer to Accuracy / Method Comparison.
As with all diagnostic assays, each laboratory should determine its own reference range(s) for
the diagnostic evaluation of patient results.10

Performance Characteristics
Analytical Measuring Range
The ADVIA Centaur CEA assay measures CEA concentrations from 0.5–100 ng/mL (µg/L).

Specificity
The potential interference of NCA (normal cross-reacting antigen) and NCA2 was tested by
adding these antigens to serum pools containing CEA. The level of CEA was then determined.

CEA value without CEA value with

Cross-reactant cross-reactant (ng/mL) (µg/L) cross-reactant (ng/mL) (µg/L)
NCA (500 ng/mL) 2.5 2.5
23.3 21.8
71.2 66.1
NCA2 (100 ng/mL) 2.5 2.5
23.3 22.9
71.2 62.0

NCA and NCA2 showed minimal interference with the recovery of CEA from the serum
samples. Average recovery is greater than 95%.

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Sensitivity
The ADVIA Centaur CEA assay measures CEA concentrations up to 100 ng/mL (µg/L) with a
minimum detectable concentration (sensitivity) of 0.5 ng/mL (µg/L). The sensitivity was
determined by diluting low patient specimens with the zero standard. The sensitivity of the
assay with a particular patient specimen was taken as the CEA concentration at the point
where the dilutions were statistically different from the zero standard and different from the
next lower dilution. The assay sensitivity was taken as the average sensitivity determined from
diluting seven patient specimens.

Precision
Four samples were assayed 6 times, in each of 12 runs, on 5 systems, (n = 72 for each sample),
over a period of 4 days. The following results were obtained:

Mean (ng/mL) (µg/L) Within-run % CV Run-to-run % CV Total % CV

2.4 3.6 4.1 5.5
14.2 3.3 2.9 4.4
31.5 2.8 4.0 4.8
51.5 2.1 2.7 3.4

Accuracy / Method Comparison

For 284 samples in the range of 0.5 to 78.5 ng/mL (µg/L), the relationship between the
ADVIA Centaur CEA assay and the ACS:180 CEA assay is described by the equation:
ADVIA Centaur CEA = 0.97 (ACS:180 CEA) + 0.04 ng/mL
Correlation coefficient (r) = 0.99

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Interferences

Serum specimens that are . . . Demonstrate ≤ 5% change in results up to . . .

hemolyzed 500 mg/dL of hemoglobin
lipemic 1000 mg/dL of triglycerides
icteric 20 mg/dL of bilirubin

Interference by Chemotherapeutic Agents

The potential interference of chemotherapeutic agents was tested by adding these agents to
serum pools containing CEA. The level of CEA in each of these pools was then determined and
normalized to the level without the respective drugs.

Amount Added Mean % Recovery

Substance (µg/mL) (Spike/control x 100)
Vincristine 0.70 100.4
Vinblastine 1.20 99.2
Cisplatinum 1.50 97.9
Tamoxifen 133 98.9
Cyclophosphamide 3300 96.9
5-Fluorouracil 360 96.9
Adriamycin 100 96.9
Folinic Acid 60 98.4
Mitomycin C 60 96.6
Methotrexate 4500 98.7
Bleomycin 1300 100.9

Interference testing was determined according to CLSI Document EP7-A2.11

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Dilution Recovery
Six serum samples in the range of 55.85 to 77.02 ng/mL (µg/L) of CEA were diluted 1:2, 1:4,
1:8, and 1:16 with CEA Diluent and assayed for recovery and parallelism. The recoveries
ranged from 79.2% to 110.9% with a mean of 96.8%.

Sample Dilution Observed (ng/mL) (µg/L) Expected (ng/mL) (µg/L) Recovery %

1 — 55.85
1:2 28.36 27.93 101.5
1:4 13.67 13.96 97.9
1:8 5.53 6.98 79.2
1:16 3.00 3.49 86.0
Mean 91.2
2 — 57.97
1:2 28.52 29.98 98.4
1:4 13.15 14.49 90.7
1:8 6.42 7.25 88.6
1:16 3.28 3.62 90.4
Mean 92.0
3 — 63.68
1:2 34.43 31.84 108.1
1:4 16.25 15.92 102.1
1:8 8.41 7.96 105.7
1:16 3.81 3.98 95.8
Mean 102.9
4 — 77.02
1:2 40.43 38.51 105.0
1:4 18.42 19.25 95.7
1:8 9.53 9.63 99.0
1:16 4.83 4.81 100.4
Mean 100.0
5 — 70.57
1:2 39.13 35.29 110.9
1:4 18.92 17.64 107.2
1:8 8.27 8.82 93.7
1:16 4.00 4.41 90.7
Mean 100.6

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Sample Dilution Observed (ng/mL) (µg/L) Expected (ng/mL) (µg/L) Recovery %

6 — 62.74
1:2 31.23 31.37 99.6
1:4 15.26 15.68 97.3
1:8 7.04 7.84 89.8
1:16 3.55 3.92 90.6
Mean 94.3

Mean 96.8

Spiking Recovery
Varying amounts of CEA were added to seven serum samples with endogenous CEA levels
ranging from 0 to 2.2 ng/mL (µg/L). The amount of CEA that was added varied from
7.0 to 83.0 ng/mL (µg/L). When compared to the expected value, the measured (recovered)
values of CEA averaged 100.8% with a range of 75.5% to 135.8%.

Sample Amount Added (ng/mL) (µg/L) Observed (ng/mL) (µg/L) Recovery %

1 — 0.5
7.0 6.5 86.6
13.0 10.2 75.5
28.0 28.6 100.5
55.0 53.7 96.8
83.0 80.5 96.5
Mean 91.2
2 — 1.6
7.0 8.3 97.2
13.0 16.7 114.7
28.0 31.3 105.9
55.0 54.5 96.2
83.0 81.0 95.8
Mean 102.0
3 — 0.2
7.0 8.5 118.6
13.0 12.1 91.4
28.0 31.4 111.3
55.0 56.1 101.5
83.0 79.0 94.9
Mean 103.5

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Sample Amount Added (ng/mL) (µg/L) Observed (ng/mL) (µg/L) Recovery %

4 — 0.8
7.0 7.0 90.0
13.0 11.1 80.7
28.0 32.6 113.2
55.0 56.2 100.8
83.0 82.0 97.9
Mean 96.5
5 — 0.6
7.0 6.9 91.8
13.0 18.4 135.8
28.0 33.1 116.0
55.0 49.9 89.9
83.0 104.4 124.9
Mean 111.7
6 — 0.3
7.0 7.0 95.4
7.0 12.7 95.7
13.0 31.5 111.2
28.0 53.3 96.5
55.0 78.1 93.8
Mean 98.5
7 — 0.7
7.0 7.9 102.2
13.0 12.2 88.7
28.0 31.7 110.6
55.0 60.4 108.5
83.0 83.6 99.8
Mean 102.0

Mean 100.8

High-Dose Hook Effect

Patient samples with high CEA levels can cause a paradoxical decrease in the RLUs (high-dose
hook effect). In this assay, patient samples with CEA levels as high as 100,000 ng/mL (µg/L) will
assay greater than 100 ng/mL (µg/L).

Standardization
The ADVIA Centaur CEA assay is traceable to an internal standard manufactured using highly
purified material. Assigned values for calibrators are traceable to this standardization.

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Troubleshooting
The following is recommended when you observe poor reproducibility of CEA values at low
levels or if you are not satisfied with assay performance:
• Ensure that the assay reagent and calibrator lot numbers and expiration dates match those
entered in the system.
• Ensure that the calibrators, quality control materials, and assay reagents were prepared
according to the recommended procedures.
• Ensure that the recommended sample collection and handling procedures were followed.
• Ensure that the recommended system cleaning procedures were followed.
• Ensure that Type II reagent water was used when operating the system.
Note For information about reagent water, refer to the system operating instructions.
• Visually check the probe and tubing for obstructions, leaks, and deformities such as
pinched or crimped tubing.
• Take further corrective action following established laboratory procedures.
• Calibrate the system using new assay reagents, calibrators, and quality control samples.
• If necessary, contact your local technical support provider or distributor for assistance.

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

References
1. Statland BE, Winkel P. Neoplasia. In:Kaplan LA, Pesc AJ, eds. Clinical Chemistry; Theory,
Analysis, and Correlation. 2nd ed. St. Louis: CV Mosby; 1989:734–5.
2. Sikorska H, Shuster J, Gold P. Clinical applications of carcinoembryonic antigen.
Cancer Detect Prev. 1988;12:321–55.
3. Lahousen M, Stettner H, Pickel H, et al. The predictive value of a combination of tumor
markers in monitoring patients with ovarian cancer. Cancer. 1987;60:2228–32.
4. Go VLW, Zamcheck N. The role of tumor markers in the management of colorectal cancer.
Cancer. 1982;50:2618–23.
5. McNeely MDD. Gastrointestinal function and digestive disease. In: Kaplan LA, Pesce AJ, eds.
Clinical Chemistry; Theory, Analysis, and Correlation. 2nd ed. St. Louis: CV Mosby;
1989:411–2.
6. Fletcher RH. Carcinoembryonic Antigen. Ann Intern Med. 1986;104:66–73.
7. Minton J, Chevinsky AH. CEA directed second-look surgery for colon and rectal cancer.
Annales Chirurgiae et Gynecologiae. 1989;78:32–7.
8. 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.
9. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays.
Clin Chem. 1988;34:27–33.

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10. Clinical and Laboratory Standards Institute (formerly NCCLS). How to Define and
Determine Reference Intervals in the Clinical Laboratory; Approved Guideline -
Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2000.
NCCLS Document C28-A2.
11. Clinical and Laboratory Standards Institute (formerly NCCLS). Interference Testing in
Clinical Chemistry; Approved Guideline - Second Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2005. CLSI Document EP7-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, ReadyPack, and ACS:180 are trademarks of Siemens Healthcare Diagnostics.
© 2014 Siemens Healthcare Diagnostics. All rights reserved.
US Pats 5,609,822; 5,788,928

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