Anti-Thyroid Peroxidase II (aTPOII)

Current Revision and Datea Rev. 01, 2024-08

Product Name ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) 11206074

(100 tests)

11206075
(500 tests)

Abbreviated Product Name ADVIA Centaur aTPOII

Test Name/ID aTPOII

Systems ADVIA Centaur XP system

ADVIA Centaur XPT system

Materials Required but Not ADVIA Centaur Wash 1 (2 x 1500 mL) 01137199
Provided (112351)

ADVIA Centaur Wash 1 (2 x 2500 mL) 03773025

Optional Materials ADVIA Centaur aTPOII Quality Control (aTPOII QC) 11206985

ADVIA Centaur aTPOII Diluent (aTPOII DIL) 11207635

(2-pack)

ADVIA Centaur aTPOII Master Curve Material (aTPOII 11203693

MCM)

Specimen Types Serum, EDTA plasma, lithium heparin plasma

Sample Volume 30 µL

Measuring Interval 10.4–400.0 IU/mL

a A vertical bar in the page margin indicates technical content that differs from the previous version.

Intended Use
The ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in
the quantitative measurement of autoantibodies against thyroid peroxidase in human serum
and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP and ADVIA Centaur® XPT
systems.
Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical
assessment, as an aid in the diagnosis of autoimmune thyroiditis.

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Summary and Explanation

Thyroid peroxidase (TPO), a 105 kDa membrane-bound heme-containing glycoprotein, plays a
critical role in the synthesis of thyroid hormones through conversion of iodide to iodine.1 This
oxidation step provides iodine atoms for addition onto tyrosine residues on another thyroid
protein, thyroglobulin (Tg), for the production of triiodothyronine (T3) and thyroxine (T4),
resulting in the release of T3 and T4 into circulation. The synthesis and secretion of T3 and T4
are tightly regulated by thyroid-stimulating hormone (TSH), as part of the hypothalamus-
pituitary-thyroid axis.2
Autoimmune diseases are conditions where the body mistakenly attacks and damages its own
tissues due to genetic and environmental triggers. Autoimmune thyroid disease (AITD) is the
most frequently occurring autoimmune disorder, affecting about 5% of the population.3 The
two main types are Hashimoto’s thyroiditis (HT) and Graves’ disease (GD), both of which are
distinguished by an infiltration of lymphocytes to the parenchyma of the thyroid.3
aTPO is the most common anti-thyroid autoantibody, present in approximately 90% of HT,
75% of GD, and 10–20% of nodular goiter or thyroid cancer patients.1 Therefore, aTPO testing
is an important aspect of laboratory testing for the diagnosis of AITD.4 In addition to this role
in diagnosis, aTPO may potentially play a role in the pathogenesis of AITD.1
Studies have demonstrated that patients with subclinical hypothyroidism and elevated aTPO
progress to overt hypothyroidism at a rate greater than patients who are below the cut‑off for
aTPO.2 In this context, monitoring of aTPO is recommended.
Additionally, pregnant euthyroid women with elevated aTPO should be monitored via monthly
TSH measurements, as recurrent pregnancy loss is associated with the presence of aTPO.2,5 In
the postpartum stage, females with elevated aTPO have an increased risk for postpartum
thyroiditis.4 This is likely due to an underlying autoimmune thyroid condition that can flare up
either during pregnancy or after childbirth.

Principles of the Procedure

This assay is a fully automated 1-step competitive immunoassay using acridinium ester (AE)
chemiluminescent technology. The assay employs 2 anti‑TPO antibodies and a recombinant
TPO antigen. The first antibody, in the Solid Phase, is a biotinylated mouse monoclonal anti-
TPO antibody that is bound to streptavidin-coated paramagnetic microparticles. The second
antibody is a mouse monoclonal anti-TPO antibody labeled with acridinium ester in a
preformed complex with unlabeled recombinant thyroid peroxidase (rTPO).
Successful bridging of the Solid Phase antibody with the AE-labeled antibody and rTPO in the
Lite Reagent will result in signal generation. Anti-TPO autoantibodies present in the sample
will compete with the Solid Phase biotinylated anti-TPO monoclonal antibody for binding to
rTPO and reduce the signal.
An inverse relationship exists between the amount of anti-TPO antibody present in the patient
sample and the amount of relative light units (RLUs) detected by the system.

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Reagents
Material Description Storage Stability

aTPOII ReadyPack® primary reagent packa, b Unopened at 2–8°C Until expiration date on
Lite Reagent product
10.0 mL/reagent pack
Recombinant TPO (~90 ng/mL) complexed with mouse Onboard 42 days
monoclonal anti-TPO antibody (~30 ng/mL) labeled
with acridinium ester in phosphate buffer; blocker
(bovine and mouse); surfactant; sodium azide
(< 0.1%); preservatives
Solid Phase
20.0 mL/reagent pack
Streptavidin-coated paramagnetic microparticles
(~0.3 mg/mL) with biotinylated mouse monoclonal
anti-TPO antibody (~6 µg/mL) in phosphate buffer;
blocker (bovine and mouse); surfactant; sodium azide
(< 0.1%); preservatives

aTPOII CALa, b Lyophilized at 2–8°C Until expiration date on

1.0 mL/vial product
After reconstitution, low and high levels of anti-TPO
(human) in defibrinated human plasma; sodium azide Reconstituted at 2–8°C 28 days
(< 0.1%); preservatives Reconstituted at room 8 hours
temperature

ADVIA Centaur aTPOII DIL ReadyPack ancillary Unopened at 2–8°C Until expiration date on
reagent packa, b, c product
2 x 5.0 mL/reagent pack
Defibrinated human plasma negative for anti-TPO Onboard 28 days
(human); sodium azide (< 0.1%); preservatives

ADVIA Centaur Wash 1a, d Unopened at 2–25°C Until expiration date on

2 x 1500 mL/pack product
Phosphate-buffered saline; sodium azide (< 0.1%);
surfactant Onboard 1 month

ADVIA Centaur Wash 1a, d Unopened at 2–25°C Until expiration date on

2 x 2500 mL/pack product
Phosphate-buffered saline; sodium azide (< 0.1%);
surfactant Onboard 1 month

a Store in an upright position.

b Prevent exposure to light.
c Refer to Optional Materials.
d Refer to Materials Required but Not Provided.

Warnings and Precautions

For in vitro diagnostic use.
For Professional Use.

CAUTION
Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare
professional.

Safety data sheets (SDS) available on siemens-healthineers.com.

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H317 Warning!
P280, P302+P352, May cause an allergic skin reaction.
P333+P313, Wear protective gloves/protective clothing/eye protection/face protection.
P362+P364, P501 IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash
occurs: Get medical advice/attention. Take off contaminated clothing and
wash it before reuse. Dispose of contents and container in accordance
with all local, regional, and national regulations.
Contains: 2-methyl-2H-isothiazol-3-one (aTPOII Lite Reagent and Solid
Phase)

H317, H373, H410 Warning!

P260, P280, P273, May cause an allergic skin reaction. May cause damage to organs
P302+P352, through prolonged or repeated exposure. Very toxic to aquatic life with
P333+P313, long lasting effects.
P362+P364, P314, Do not breathe dust. Wear protective gloves/protective clothing/eye
P391, P501 protection/face protection. Avoid release to the environment. IF ON SKIN:
Wash with plenty of soap and water. If skin irritation or rash occurs: Get
medical advice/attention. Take off contaminated clothing and wash it
before reuse. Get medical advice/attention if you feel unwell. Collect
spillage. Dispose of contents and container in accordance with all local,
regional, and national regulations.
Contains: pyridine-2-thiol 1-oxide, sodium salt; sodium azide;
gentamicin sulfate (aTPOII CAL)

Contains: pyridine-2-thiol 1-oxide, sodium salt. Toxic by eye contact. (aTPOII CAL)

Contains: pyridine-2-thiol 1-oxide, sodium salt. May produce an allergic reaction.

(ADVIA Centaur aTPOII DIL)

Warning! Potential Biohazard

Contains human source material.
No known test method can ensure that products derived from human source materials will not
transmit infection. These materials should be handled using good laboratory practices and
universal precautions.6-8

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.
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.

Storage and Stability

Store all reagents in an upright position, away from light. Do not use products beyond the
expiration date printed on the product labeling or beyond the in-use stability interval.
For information about product storage and stability, refer to Reagents.

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Specimen Collection and Handling

Serum and plasma (EDTA and lithium heparin) are the recommended specimen types for this
assay.
The handling and storage information provided here is based on data or references
maintained by the manufacturer. 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.

Collecting the Specimen

• Observe universal precautions when collecting specimens. Handle all specimens as if they
are capable of transmitting disease.8
• Follow recommended procedures for collection of diagnostic blood specimens by
venipuncture.9
• Follow the instructions provided with your specimen collection device for use and
processing.10
• Allow blood specimens to clot completely before centrifugation.11
• Keep tubes capped at all times.11
• Do not use samples that have been stored at room temperature for longer than 8 hours.

Storing the Specimen

• After centrifugation, specimens in the primary collection device are stable for up to
8 hours at room temperature. Samples in the primary collection device include plasma
stored on packed red cells, and serum samples processed and stored in gel-barrier blood
collection tubes.
• Separated samples are stable for up to 8 hours at room temperature, and for up to 7 days
at 2–8°C.
• Separated samples are stable at ≤ -20°C for up to 6 months. Avoid more than 2 freeze-
thaw cycles. Do not store in a frost-free freezer. Thoroughly mix thawed samples and
centrifuge them before using.

Transporting the Specimen

Package and label specimens for shipment in compliance with applicable federal and
international regulations covering the transport of clinical specimens and etiological agents.

Preparing the Samples

This assay requires 30 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 a complete list of appropriate
sample containers and information about determining the minimum required volume, refer to
the system online help.
The sample volume required to perform onboard dilution differs from the sample volume
required to perform a single determination on an undiluted sample. Refer to Dilutions.
Do not use samples with apparent contamination.
Before placing samples on the system, ensure that samples are free of:
• Bubbles or foam.
• Fibrin or other particulate matter.

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Remove particulates by centrifugation according to CLSI guidance and the collection device
manufacturer’s recommendations.11

Procedure
Materials Provided
The following materials are provided:

Number of
Contents Tests

11206074 1 ReadyPack primary reagent pack containing aTPOII Lite Reagent and Solid Phase 100
ADVIA Centaur aTPOII master curve card
1 vial aTPOII CAL low calibrator
1 vial aTPOII CAL high calibrator
ADVIA Centaur aTPOII CAL calibrator assigned value cards and barcode labels

11206075 5 ReadyPack primary reagent packs containing aTPOII Lite Reagent and Solid Phase 500
ADVIA Centaur aTPOII master curve card
2 vials aTPOII CAL low calibrator
2 vials aTPOII CAL high calibrator
ADVIA Centaur aTPOII CAL calibrator assigned value cards and barcode labels

Materials Required but Not Provided

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

Description

ADVIA Centaur XP systema

ADVIA Centaur XPT systema

01137199 ADVIA Centaur Wash 1 (wash)

(112351)

03773025 ADVIA Centaur Wash 1 (wash)

a Additional system fluids are required to operate the system: ADVIA Centaur Acid Reagent, ADVIA Centaur Base
Reagent, and ADVIA Centaur Cleaning Solution.

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

Description

11206985 ADVIA Centaur aTPOII QC (quality control material)

11207635 ADVIA Centaur aTPOII DIL (2-pack) (diluent)

11203693 ADVIA Centaur aTPOII MCM (master curve material)

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Assay Procedure
The system automatically performs the following steps:
1. Dispenses 30 µL of sample into a cuvette.
2. Dispenses 100 µL of Lite Reagent, then incubates for 3 minutes at 37°C.
3. Dispenses 200 µL of Solid Phase, then incubates for 6 minutes at 37°C.
4. Separates the Solid Phase, aspirates, then washes the cuvettes with ADVIA Centaur
Wash 1.
5. Dispenses 300 µL each of ADVIA Centaur Acid Reagent and ADVIA Centaur Base Reagent
to initiate the chemiluminescent reaction.
6. Reports results.

Preparing the Reagents

All reagents are liquid and ready to use. Before loading the packs onto the system, reagents
require mixing. For information about mixing the reagents, refer to the system online help.

Preparing the System

Ensure that sufficient materials are loaded on the system. Refer to Materials Provided and
Materials Required but Not Provided for guidance about required reagents.
For information about loading products, refer to the system online help.

Master Curve Definition

Before initiating calibration on each new lot of reagent, enter the assay master curve values by
scanning the master curve card. For information about defining the master curve, refer to the
system online help.

Performing Calibration
For calibration of the assay, use the calibrators provided with each kit.
Note Calibrators provided in an assay kit must only be used with the reagent lot provided in
the same kit.

Calibration Frequency
Perform a calibration if one or more of the following conditions exist:
• At the end of the 42‑day calibration interval.
• When changing lot numbers of primary reagent packs.
• When indicated by quality control results.
• After major maintenance or service, if indicated by quality control results.
Follow government regulations or accreditation requirements for calibration frequency.
Individual laboratory quality control programs and procedures may require more frequent
calibration.

Preparing the Calibrators

Reconstitute the materials using the following steps:
1. Add 1.0 mL of reagent water into each vial. Replace cap.
Note For information about reagent water requirements, refer to the system online help.

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2. Let the vials stand for 15–20 minutes at room temperature to allow the lyophilized
material to dissolve.
3. Gently mix and invert the vials to ensure homogeneity of the material.
Use calibrators within the stability limits specified in Reagents and discard any remaining
material.

Calibration Procedure
Perform the procedure using the following steps:
1. Ensure that the appropriate master curve and calibrator assigned values are entered on
the system. For information about defining the master curve and entering calibrator
values, refer to the system online help.
2. Load the required reagents for the assay.
3. Schedule the calibrators.
4. Label sample containers with barcode labels: one container for each level. Place the
barcode labels on the sample containers with the readable characters oriented vertically.
Note Barcode labels are lot-specific. Do not use barcode labels from one lot of calibrators
with any other lot of calibrators.
5. Gently mix and dispense a sufficient volume of each level into the appropriate sample
container. Avoid bubbles.
The required sample volume for testing depends on several factors. For information about
sample volume requirements, refer to the system online help.
6. Load the samples according to the system online help.
Note Dispose of any material that remains in the sample container at the end of the room
temperature stability interval. Do not refill or reuse sample containers. Do not return material
back into the original container.

Performing Quality Control

For quality control of the ADVIA Centaur aTPOII assay, use the ADVIA Centaur aTPOII QC or an
equivalent product at least once during each day that samples are analyzed.
Additional quality control material can be used at the discretion of the laboratory. Use the
quality control material in accordance with the quality control instructions for use.
In addition, perform quality control:
• Following a valid calibration
• With use of a new lot of reagent
• When troubleshooting test results that do not match clinical conditions or symptoms
Follow government regulations or accreditation requirements for quality control frequency.
Individual laboratory quality control programs and procedures may require more frequent
quality control testing.
Acceptable performance is achieved when the analyte values obtained are within the expected
control interval for the system, as indicated by the manufacturer of the control material or
within the interval determined by an internal laboratory quality control procedure.
Follow your laboratory’s quality control procedures if the results obtained do not fall within the
acceptable limits. For information about entering quality control definitions, refer to the
system online help.

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Taking Corrective Action

If the quality control results do not fall within the expected control interval, do not report
results. Perform corrective actions in accordance with established laboratory protocol. For
suggested protocol, refer to the system online help.

Results
Calculation of Results
The system determines the result using the calculation procedure described in the system
online help. The system reports results in IU/mL.
For information about results outside the specified measuring interval, refer to Measuring
Interval.

Dilutions
Dilute and retest samples with anti‑TPO levels > 400.0 IU/mL to obtain quantitative results. For
information about dilution options, refer to the system online help.
Note Due to the heterogeneity of autoantibodies, some patient samples may exhibit a non-
linear dilution.
For automated dilutions, perform the following activities:
• Load ADVIA Centaur aTPOII DIL.
• Ensure that sufficient sample volume is available. Refer to the table below.
• Select the appropriate dilution factor.
For automatic dilutions, enter a Dilution Point ≤ 400 IU/mL.

Sample Dilution Sample Volume (µL)

Serum and plasma 1:10 30

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

Limitations
The following information pertains to limitations of the assay:
• Results obtained with the assay may not be used interchangeably with values obtained
with different manufacturers' anti-TPO methods.
• The performance of the assay has not been established with specimen types other than
those defined in the Intended Use.
• Patient samples may contain heterophilic antibodies that could react in immunoassays and
cause falsely elevated or depressed results.12,13 This assay is designed to minimize
interference from heterophilic antibodies. Additional information, such as the patient’s
medical history and clinical presentation, should be considered in conjunction with the
test result.

Expected Values
A reference interval for apparently healthy adults was established non‑parametrically using the
ADVIA Centaur XP system in accordance with CLSI Document EP28‑A3c.14

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Samples were collected prospectively from euthyroid male and female adult subjects with
normal TSH and thyroid hormone levels. The reference interval was determined by calculating
the 95th percentile of the distribution of values.

Median Reference Interval

Group Na IU/mL IU/mL

Adults (23–96 years) 267 < 10.4 < 13.8

a Number of samples tested.
As with all in vitro diagnostic assays, each laboratory should determine its own reference
interval for the diagnostic evaluation of patient results.14 Consider these values as guidance
only.

Performance Characteristics
Measuring Interval
10.4–400.0 IU/mL
The lower limit of the measuring interval is defined by the limit of quantitation (LoQ). Report
results below the measuring interval as < 10.4 IU/mL.
When sample results exceed the measuring interval, refer to Dilutions. The extended
measuring interval of the assay is 10.4–4000 IU/mL using a 1:10 dilution.

Detection Capability
Detection capability was determined in accordance with CLSI Document EP17-A2.15 Results
obtained at individual laboratories may vary from the data presented.

Detection Capability Result

Limit of Blank (LoB) 3.9 IU/mL

Limit of Detection (LoD) 6.7 IU/mL

Limit of Quantitation (LoQ) 10.4 IU/mL

The LoB corresponds to the highest measurement result likely to be observed for a blank
sample with a probability of 95%. The assay is designed to have an LoB ≤ 5.0 IU/mL.
The LoD corresponds to the lowest analyte concentration that can be detected with a
probability of 95%. The assay is designed to have an LoD ≤ 8.0 IU/mL
The LoQ corresponds to the lowest analyte concentration at which the within laboratory CV is
≤ 20%. The assay is designed to have an LoQ ≤ 12.0 IU/mL.

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Sensitivity and Specificity

Sensitivity and specificity were determined using the ADVIA Centaur XP system in accordance
with CLSI Document EP12‑A2.16 The performance of the ADVIA Centaur aTPOII assay was
compared to a commercially available anti-TPO assay using 485 autoimmune thyroiditis and
non-autoimmune thyroiditis patient samples. The following results were obtained:

Comparative Assay

Positive Negative Total

ADVIA Centaur aTPOII Assay ≥ 13.8 IU/mL 168 0 168

< 13.8 IU/mL 25 292 317

Total 193 292 485

Relative Sensitivity: 87.05% (168/193) [95% Confidence Interval: 81.58%–91.07%]

Relative Specificity: 100% (292/292) [95% Confidence Interval: 98.70%–100%]
Overall Agreement: 94.85% (460/485) [95% Confidence Interval: 92.50%–96.48%]

Agreement of the assays may vary depending on the study design, comparative assay, and
population tested.

Precision
Precision was determined in accordance with CLSI Document EP05‑A3.17 Samples were
assayed in replicates of 2 with 2 runs per day using a 20‑day protocol. The following results are
representative of the performance of the assay:

Repeatability Within-Laboratory Precision

Mean SDb CVc SD CV

Sample Na (IU/mL) (IU/mL) (%) (IU/mL) (%)

Serum A 80 15.9 1.79 11.3 1.79 11.3

Serum B 80 23.8 2.21 9.3 2.45 10.3

Serum C 80 26.5 1.99 7.5 2.39 9.0

Serum D 80 129.7 5.47 4.2 6.65 5.1

Serum E 80 184.4 10.52 5.7 12.98 7.0

Serum F 80 356.1 19.85 5.6 22.72 6.4

Control 1 80 29.7 2.29 7.7 2.65 8.9

Control 2 80 201.0 9.54 4.7 14.91 7.4

a Number of measurements.
b Standard deviation.
c Coefficient of variation.

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The assay was designed to have the following precision when using a 20‑day protocol in
accordance with CLSI Document EP05‑A3.17

Precision

Concentration Interval Repeatability (Within-Run) Within-Laboratory (Total Precision)

10.4 – < 17.0 IU/mL ≤ 18.0% CV ≤ 20.0% CV

17.0 – < 24.0 IU/mL ≤ 12.0% CV ≤ 14.0% CV

24.0 – < 40.0 IU/mL ≤ 10.0% CV ≤ 12.0% CV

40.0 – < 300.0 IU/mL ≤ 8.0% CV ≤ 10.0% CV

300.0–400.0 IU/mL ≤ 10.0% CV ≤ 12.0% CV

Reproducibility
Reproducibility was determined in accordance with CLSI Document EP05‑A3.17 Testing was
performed using 3 instruments and 3 reagent lots. Samples were assayed in replicates of 5
with 1 run per day using a 5‑day protocol. (Number of measurements per sample = 225.) The
following results are representative of the performance of the assay:

Repeatability Between Day Between Instrument Between Lot Reproducibility

Mean SDa CVb SD CV SD CV SD CV SD CV

Sample (IU/mL) (IU/mL) (%) (IU/mL) (%) (IU/mL) (%) (IU/mL) (%) (IU/mL) (%)

Serum A 16.1 1.14 7.1 0.85 5.3 1.16 7.2 0.42 2.6 1.88 11.7

Serum B 23.4 1.56 6.7 0.95 4.1 0.51 2.2 0.41 1.8 1.94 8.3

Serum C 28.9 1.87 6.5 0.92 3.2 0.60 2.1 2.16 7.5 3.07 10.6

Serum D 131.9 6.20 4.7 3.16 2.4 2.33 1.8 11.23 8.5 13.41 10.2

Serum E 172.0 9.38 5.5 4.25 2.5 3.64 2.1 13.41 7.8 17.30 10.1

Serum F 358.6 17.96 5.0 15.56 4.3 9.98 2.8 27.58 7.7 37.75 10.5

Control 1 30.3 1.80 5.9 1.23 4.1 0.77 2.5 0.63 2.1 2.39 7.9

Control 2 178.7 10.14 5.7 3.52 2.0 1.48 0.8 10.35 5.8 14.98 8.4

a Standard deviation.
b Coefficient of variation.
The assay was designed to have the following reproducibility when using a 5‑day protocol in
accordance with CLSI Document EP05‑A3.17

Concentration Interval Reproducibility

10.4 – < 17.0 IU/mL ≤ 20.0% CV

17.0 – < 40.0 IU/mL ≤ 18.0% CV

40.0–400.0 IU/mL ≤ 15.0% CV

Specimen Equivalency
Specimen equivalency was determined with the Passing-Bablok regression model using the
ADVIA Centaur XP system in accordance with CLSI Document EP09c‑ed3.18
Agreement of the specimen types may vary depending on the study design and population
tested.

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Tube (y) vs. Serum (x) Regression Equation Sample Interval Na rb

Plasma, dipotassium EDTA y = 1.00x - 1.0 IU/mL 5.3–380.9 IU/mL 55 0.974

Plasma, lithium heparin y = 0.94x - 0.1 IU/mL 5.3–398.0 IU/mL 55 0.987

a Number of samples tested.
b Correlation coefficient.
The assay is designed to have a correlation coefficient of ≥ 0.950, a slope of 0.90–1.10, and an
intercept of ± 10.4 IU/mL.

Interferences
Hemolysis, Icterus, Lipemia (HIL)
Interference testing was performed using the ADVIA Centaur XP system in accordance with
CLSI Document EP07‑ed3.19 The following substances do not interfere with the assay when
present in serum at the concentrations indicated. Bias due to these substances does not
exceed ± 4.0 IU/mL at anti-TPO concentrations of 10.0–40.0 IU/mL and ± 10.0% at anti-TPO
concentrations of 130.0–270.0 IU/mL.

Substance Substance Test Concentration

Hemoglobin 1000 mg/dL (10 g/L)

Bilirubin, conjugated 60 mg/dL (712 µmol/L)

Bilirubin, unconjugated 60 mg/dL (1026 µmol/L)

Lipemia (Intralipid) 3500 mg/dL (35 g/L)

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Other Substances
Interference testing was performed using the ADVIA Centaur XP system in accordance with
CLSI Document EP07‑ed3.19 The following substances do not interfere with the assay when
present in serum at the concentrations indicated. Bias due to these substances does not
exceed ± 4.0 IU/mL at anti-TPO concentrations of 10.0–40.0 IU/mL and ± 10.0% at anti-TPO
concentrations of 130.0–270.0 IU/mL.

Substance Substance Test Concentration Substance Substance Test Concentration

Acetaminophen 20 mg/dL (1323 µmol/L) Liothyronine 0.0075 mg/dL (0.115 µmol/L)

Acetylcysteine 15 mg/dL (919.1 µmol/L) Losartan potassium 0.2 mg/dL (4.73 µmol/L)

Acetylsalicylic acid (aspirin) 65 mg/dL (3608 µmol/L) Methimazole 8 mg/dL (700.7 µmol/L)

Ampicillin sodium 7.5 mg/dL (201.9 µmol/L) Methyldopa 2.25 mg/dL (106.5 µmol/L)

Ascorbic acid 5.25 mg/dL (298.1 µmol/L) Methylprednisolone 0.783 mg/dL (20.9 µmol/L)

Atorvastatin calcium 0.075 mg/dL (1.34 µmol/L) Metoprolol tartrate 0.15 mg/dL (5.61 µmol/L)

Biotin 3500 ng/mL (14.3 µmol/L) Metronidazole 12.3 mg/dL (702.9 µmol/L)

Carbimazole 3 mg/dL (161.1 µmol/L) Octreotide 0.03 mg/dL (0.294 µmol/L)

Cefoxitin 660 mg/dL (15.44 mmol/L) Omeprazole 0.84 mg/dL (24.32 µmol/L)

Cholesterol 400 mg/dL (10.4 mmol/L) Phenylbutazone 32.1 mg/dL (1.04 mmol/L)

Cyclosporine 0.18 mg/dL (1.5 µmol/L) Prednisone 9.9 µg/dL (0.276 µmol/L)

Dexamethasone 1.2 mg/dL (30.6 µmol/L) Propranolol Hydrochloride 24 mg/dL (811.4 µmol/L)

Doxycycline 1.8 mg/dL (40.5 µmol/L) Propylthiouracil 30 mg/dL (1.76 mmol/L)

EDTA, tripotassium 425 mg/dL (9.60 mmol/L) Rheumatoid factor (RF) 750 IU/mL

Human anti-mouse antibody 67 ng/mL (67 µg/L) Rifampicin 4.8 mg/dL (58.3 µmol/L)
(HAMA)

Ibuprofen 50 mg/dL (2424 µmol/L) Silwet L 720 0.03 mg/mL (101 µmol/L)
(Octamethylcyclotetrasiloxane)

Immunoglobulin G (IgG) 6 g/dL (60 g/L) Theophylline 6 mg/dL (333.0 µmol/L)

Iodide 38 mg/dL (2.99 mmol/L) Thyroxine 1000 µg/mL (1.29 mmol/L)

Levodopa 0.75 mg/dL (38.0 µmol/L) Total Protein 12 g/dL (120 g/L)

Cross-Reactivity
Cross-reactivity was determined using the ADVIA Centaur XP system in accordance with CLSI
Document EP07‑ed3.19 Cross-reactivity of samples spiked with various substances does not
exceed ± 5.0% at anti-TPO concentrations of 10.0–40.0 IU/mL and 130.0–270.0 IU/mL.

Substance Substance Test Concentration

Anti-thyroglobulin antibody (TgAb) 2000 IU/mL

Thyroglobulin (Tg) 700 ng/mL

Thyroid-stimulating immunoglobulin (TSI) 113 IU/L

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Linearity
Linearity testing was performed in accordance with CLSI Document EP06‑ed2.20 The assay is
linear for the measuring interval of 10.4–400.0 IU/mL.

Onboard Dilution Recovery

Samples that exceed the high end of the measuring interval may be diluted 1:10 with
ADVIA Centaur aTPOII DIL using automated dilution. The assay is designed to have a mean
recovery of 90–110%.
Note Due to the heterogeneity of autoantibodies, some patient samples may exhibit a non-
linear dilution.

Standardization
The assay standardization is traceable to the NIBSC (National Institute for Biological Standards
and Control) 66/387 Research Standard, Human Anti-Thyroid Microsome Serum, and to the
World Health Organization (WHO) 1st International Standard for Anti-Thyroid Peroxidase
Antibodies, NIBSC code 19/260. Assigned values for calibrators and controls are traceable to
this standardization.

Technical Assistance
According to EU regulation 2017/746, any serious incident that has occurred in relation to the
device shall be reported to the manufacturer and the competent authority of the EU Member
State in which the user and/or patient is established.
For customer support, contact your local technical support provider or distributor.
siemens-healthineers.com

References
1. Rifai N, Horvath AR, Wittwer CT. Tietz Textbook of Clinical Chemistry and Molecular
Diagnostics. 6th ed. 2018.
2. Soh SB, Aw TC. Laboratory Testing in Thyroid Conditions - Pitfalls and Clinical Utility. Ann
Lab Med. 2019;39(1):3–14. doi:10.3343/alm.2019.39.1.3
3. Richard-Eaglin A, Smallheer BA. Immunosuppressive/Autoimmune Disorders. Nurs Clin
North Am. 2018;53(3):319–334. doi:10.1016/j.cnur.2018.04.002
4. Ragusa F, Fallahi P, Elia G, et al. Hashimotos' thyroiditis: Epidemiology, pathogenesis, clinic
and therapy. Best Pract Res Clin Endocrinol Metab. 2019;33(6):101367. doi:10.1016/
j.beem.2019.101367
5. Huchon C, Deffieux X, Beucher G, et al. Pregnancy loss: French clinical practice guidelines.
Eur J Obstet Gynecol Reprod Biol. 2016;201:18–26. doi:10.1016/j.ejogrb.2016.02.015
6. US Department of Health and Human Services. Biosafety in Microbiological and
Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office;
December 2009.
7. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World Health
Organization; 2004.
8. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers From
Occupationally Acquired Infections; Approved Guideline—Fourth Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2014. CLSI Document M29‑A4.
9. Clinical and Laboratory Standards Institute. Procedures for the Collection of Diagnostic
Blood Specimens by Venipuncture; Approved Standard—Sixth Edition. Wayne, PA: Clinical
and Laboratory Standards Institute; 2007. CLSI Document GP41‑A6.

11206078_EN Rev. 01, 2024-08 15 / 18

aTPOII ADVIA Centaur XP and ADVIA Centaur XPT Systems

10. Clinical and Laboratory Standards Institute. Tubes and Additives for Venous and Capillary
Blood Specimen Collection; Approved Standard—Sixth Edition. Wayne, PA: Clinical and
Laboratory Standards Institute; 2010. CLSI Document GP39‑A6.
11. Clinical and Laboratory Standards Institute. Procedures for the Handling and Processing of
Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition.
Wayne, PA: Clinical and Laboratory Standards Institute; 2010. CLSI Document GP44‑A4.
12. Kricka LJ. Human anti-animal antibody interferences in immunological assays. Clin Chem.
1999;45(7):942–956.
13. Tate J, Ward G. Interferences in Immunoassay. Clin Biochem. May 2004;25:105–120.
14. Clinical and Laboratory Standards Institute. Defining, Establishing, and Verifying Reference
Intervals in the Clinical Laboratory; Approved Guideline—Third Edition. Wayne, PA: Clinical
and Laboratory Standards Institute; 2010. CLSI Document EP28‑A3c.
15. Clinical and Laboratory Standards Institute. Evaluation of Detection Capability for Clinical
Laboratory Measurement Procedures; Approved Guideline—Second Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2012. CLSI Document EP17‑A2.
16. Clinical and Laboratory Standards Institute. User Protocol for Evaluation of Qualitative Test
Performance; Approved Guideline—Second Edition. Wayne, PA: Clinical and Laboratory
Standards Institute; 2008. CLSI Document EP12‑A2.
17. Clinical and Laboratory Standards Institute. Evaluation of Precision of Quantitative
Measurement Procedures; Approved Guideline—Third Edition. Wayne, PA: Clinical and
Laboratory Standards Institute; 2014. CLSI Document EP05‑A3.
18. Clinical and Laboratory Standards Institute. Measurement Procedure Comparison and Bias
Estimation Using Patient Samples; Approved Guideline—Third Edition. Wayne, PA: Clinical
and Laboratory Standards Institute; 2018. CLSI Document EP09c‑ed3.
19. Clinical and Laboratory Standards Institute. Interference Testing in Clinical Chemistry;
Approved Guideline—Third Edition. Wayne, PA: Clinical and Laboratory Standards Institute;
2018. CLSI Document EP07‑ed3.
20. Clinical and Laboratory Standards Institute. Evaluation of Linearity of Quantitative
Measurement Procedures; Approved Guideline—Second Edition. Wayne, PA: Clinical and
Laboratory Standards Institute; 2020. CLSI Document EP06‑ed2.

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

Symbol Symbol Title Source Symbol Symbol Title Source

Manufacturer 5.1.1a Authorized representative 5.1.2a

in the European
Community

Use-by date 5.1.4a Authorized representative Proprietary

in Switzerland

Catalog number 5.1.6a Batch code 5.1.5a

Consult Instructions for 5.4.3a Contains sufficient for <n> 5.5.5a

Use tests

Internet URL address to Proprietary Version of Instructions for Proprietary

access the electronic Use
instructions for use

In vitro diagnostic medical 5.5.1a Revision Proprietary

device

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ADVIA Centaur XP and ADVIA Centaur XPT Systems aTPOII

Symbol Symbol Title Source Symbol Symbol Title Source

Prescription device (US FDAb Unique Device Identifier 5.7.10c

only)

CE Marking with Notified EU IVDRd CE Marking EU IVDRd

Body

Temperature limit 5.3.7a Keep away from sunlight 5.3.2a

Upper limit of temperature 5.3.6a Lower limit of tempera- 5.3.5a

ture

Do not re-use 5.4.2a Do not freeze Proprietary

Recycle 1135e This way up 0623e

Biological risks 5.4.1a Caution 5.4.4a

Common Units Proprietary International System of Proprietary

Units

YYYY-MM-DD Date format (year-month- N/A YYYY-MM Date format (year-month) N/A
day)

Document face upf 1952e Target Proprietary

Handheld barcode scanner Proprietary Interval Proprietary

Lot details Proprietary Variable hexadecimal Proprietary

number that ensures the
Master Curve and Cali-
brator definition values
entered are valid.

Calibrator lot value Proprietary Master Curve definition Proprietary

Quality control lot value Proprietary

a International Standard Organization (ISO). ISO 15223-1 Medical Devices- Symbols to be used with medical
device labels, labelling and information to be supplied.
b Federal Register. Vol. 81, No 115. Wednesday, June 15, 2016. Rules and Regulations: 38911.
c ISO 15223-1:2020-04
d IVDR REGULATION (EU) 2017/746
e International Standard Organization (ISO). ISO 7000 Graphical symbols for use on equipment.
f Indicates Assay-eNote

Legal Information
ADVIA Centaur and ReadyPack are trademarks of Siemens Healthineers.
© 2024 Siemens Healthineers. All rights reserved.
US Pats 11,327,074; 11,835,518

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aTPOII ADVIA Centaur XP and ADVIA Centaur XPT Systems

Siemens Healthcare Diagnostics Products Ltd.

Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL
United Kingdom

Siemens Healthineers Headquarters

Siemens Healthcare GmbH
Henkestraße 127
91052 Erlangen
Germany
Phone: +49 9131 84-0
siemens-healthineers.com

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