08906556500V3.

Elecsys Tg II
cobas e 411
08906556190 08906556500 100 cobas e 601
cobas e 602

English Detection of occult and early recurrence of disease has traditionally

required Tg stimulation with high TSH concentrations. However, the
System information development of highly sensitive assays allows Tg detection at very low
For cobas e 411 analyzer: test number 2400 concentrations without the need for stimulation.16,23,24 Using these very
For cobas e 601 and cobas e 602 analyzers: Application Code sensitive Tg assays an increased number of ‘thyroglobulin-positive’ patients
Number 005 may be observed, even if patients show no clinical evidence of disease.22
Please note These patients cannot be defined as disease-free and should be monitored
according to current guidelines. Different cutoff values are published to
Thyroglobulin (Tg) determinations can be affected by the presence of Tg distinguish between monitoring patients and patients with recurrence of
autoantibodies (anti‑Tg) in some patient samples. These autoantibodies disease who need further diagnosis and treatment. Alternatively,
may interfere with the assay used to measure Tg, causing false high or institutional cutoff levels can be established to tailor the follow-up strategies
to the local patient population and the thyroglobulin test used.17,18,19,22
false low Tg values.1,2
All Tg results should be interpreted in conjunction with the total clinical
The measured Tg value of a patient’s sample can also vary depending on presentation of the patient, including symptoms, clinical history, data from
the assay used. The laboratory finding must therefore always contain a additional tests (i.e. neck ultrasound, whole body scan) and other
statement on the Tg assay method used. Tg values determined on patient appropriate information.
samples by different assays cannot be directly compared with one Tg determinations can be affected by the presence of Tg autoantibodies
another and could be the cause of erroneous medical interpretations. If causing false high or false low Tg values. Therefore anti‑Tg determinations
are recommended for all Tg samples to rule out this interference.1,2
there is a change in the Tg assay procedure used while patient
monitoring, the Tg values obtained upon changing to the new procedure Test principle
must be confirmed by parallel measurements with both methods.2,3 Sandwich principle. Total duration of assay: 18 minutes.
▪ 1st incubation: Tg from 35 µL of sample, a biotinylated monoclonal
Intended use Tg‑specific antibody and monoclonal Tg‑specific antibodies labeled with
Immunoassay for the in vitro quantitative determination of thyroglobulin in a ruthenium complexa) react to form a sandwich complex.
human serum and plasma. Determination of Tg is used as an aid in
monitoring after thyroid ablation. ▪ 2nd incubation: After addition of streptavidin-coated microparticles, the
complex becomes bound to the solid phase via interaction of biotin and
The electrochemiluminescence immunoassay “ECLIA” is intended for use streptavidin.
on cobas e immunoassay analyzers.
▪ The reaction mixture is aspirated into the measuring cell where the
Summary microparticles are magnetically captured onto the surface of the
Thyroglobulin is a glycoprotein with a molecular weight of approximately electrode. Unbound substances are then removed with
660 kDa.4,5 Tg is synthesized in large quantities by the thyrocytes and ProCell/ProCell M. Application of a voltage to the electrode then induces
released into the follicular lumen.5,6 chemiluminescent emission which is measured by a photomultiplier.
Tg plays a decisive role in the synthesis of the peripheral thyroid hormones ▪ Results are determined via a calibration curve which is instrument-
T3 and T4. It contains approximately 132 tyrosine residues, and around a specifically generated by 2‑point calibration and a master curve provided
third of these can be iodinated to monoiodo- and diiodothyrosine (MIT and via the reagent barcode or e‑barcode.
DIT) in the presence of TPO (thyroid peroxidase) and iodide.7,8 The a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
subsequent coupling of MIT and DIT to form T3 and T4 also takes place on
the Tg matrix with the involvement of TPO.7,8,9 Reagents - working solutions
Synthesis of T3 and T4 from Tg is regulated by TSH, intrathyroidal iodine The reagent rackpack is labeled as TG 2.
levels and the presence of thyroid-stimulating immunoglobulins.9,10,11
M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:
During synthesis of Tg by the thyrocytes and the transport of Tg to the Streptavidin-coated microparticles 0.72 mg/mL; preservative.
follicles, small quantities of the protein can pass into the bloodstream.
Accordingly, low concentrations of Tg can be found in the blood of healthy R1 Anti‑Tg-Ab~biotin (gray cap), 1 bottle, 9 mL:
individuals not suffering from thyroid diseases.5 Biotinylated monoclonal anti‑Tg antibody (mouse) 1 mg/L; Bis‑Tris
Elevated Tg concentrations have been reported in many different thyroid buffer 50 mmol/L, pH 6.3; preservative.
conditions such as Hashimoto’s disease, Graves’ disease, thyroid
adenoma, and thyroid carcinoma. The determination of Tg can also be R2 Anti‑Tg‑Ab~Ru(bpy) (black cap), 1 bottle, 9 mL:
helpful to distinguish between subacute thyroiditis and factitious Monoclonal anti‑Tg antibodies (mouse) labeled with ruthenium
thyrotoxicosis. In cases of congenital hypothyroidism the determination of complex 3.1 mg/L; Bis‑Tris buffer 50 mmol/L, pH 6.3; preservative.
Tg can be used to differentiate between the complete absence of the
thyroid gland and thyroid hypoplasia or other pathological conditions.12,13,14 Precautions and warnings
The main application of Tg testing is the post-operative follow-up of patients For in vitro diagnostic use for health care professionals. Exercise the
with differentiated thyroid carcinoma (DTC). A global rise in the prevalence normal precautions required for handling all laboratory reagents.
of DTC has resulted in higher numbers of thyroidectomized patients who Infectious or microbial waste:
require lifelong monitoring for persistent or recurrent disease.15,16 As the Warning: handle waste as potentially biohazardous material. Dispose of
thyroid gland is the only known source of Tg, the serum Tg level will drop to waste according to accepted laboratory instructions and procedures.
a very low or undetectable concentration after total or near-total Environmental hazards:
thyroidectomy and successful radioiodine ablation of the residual thyroid Apply all relevant local disposal regulations to determine the safe disposal.
tissue. Detectable levels of serum Tg after total thyroidectomy are indicative
of persistent or recurrent DTC. As a consequence significantly increasing Safety data sheet available for professional user on request.
Tg levels are interpreted as a sign of recurrence of the disease.17,18,19,20,21,22 This kit contains components classified as follows in accordance with the
In patients who have undergone a partial thyroidectomy Tg levels will still Regulation (EC) No. 1272/2008:
be measurable depending on how much tissue is remaining after surgery.

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Elecsys Tg II
Do not use samples and controls stabilized with azide.
Ensure the samples, calibrators and controls are at 20‑25 °C prior to
measurement.
Due to possible evaporation effects, samples, calibrators and controls on
Warning the analyzers should be analyzed/measured within 2 hours.
Materials provided
H317 May cause an allergic skin reaction.
See “Reagents – working solutions” section for reagents.
Prevention:
Materials required (but not provided)
P261 Avoid breathing mist or vapours. ▪ 08991405190, Tg II CalSet, for 4 x 1.0 mL
P272 Contaminated work clothing should not be allowed out of ▪ 11731416190, PreciControl Universal, for 4 x 3.0 mL or
06445918190, PreciControl Thyro Sensitive, for 4 x 2.0 mL
the workplace.
▪ 03609987190, Diluent MultiAssay, 2 x 16 mL sample diluent
P280 Wear protective gloves. ▪ Anti‑Tg assay, to verify the presence of antibodies to Tg in patient
Response: samples (e.g. Elecsys Anti‑Tg assay, 04738578191)
▪ Distilled or deionized water
P333 + P313 If skin irritation or rash occurs: Get medical
▪ General laboratory equipment
advice/attention.
▪ cobas e analyzer
P362 + P364 Take off contaminated clothing and wash it before reuse. Additional materials for the cobas e 411 analyzer:
Disposal: ▪ 11662988122, ProCell, 6 x 380 mL system buffer
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
P501 Dispose of contents/container to an approved waste solution
disposal plant.
▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
Product safety labeling follows EU GHS guidance.
▪ 11933159001, Adapter for SysClean
Contact phone: all countries: +49-621-7590
▪ 11706802001, AssayCup, 60 x 60 reaction cups
Avoid foam formation in all reagents and sample types (specimens,
calibrators and controls). ▪ 11706799001, AssayTip, 30 x 120 pipette tips
Reagent handling ▪ 11800507001, Clean‑Liner
The reagents in the kit have been assembled into a ready‑for‑use unit that Additional materials for cobas e 601 and cobas e 602 analyzers:
cannot be separated. ▪ 04880340190, ProCell M, 2 x 2 L system buffer
All information required for correct operation is read in from the respective ▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
reagent barcodes. solution
Storage and stability ▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
Store at 2‑8 °C. CleanCell M before use
Do not freeze. ▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
Store the Elecsys reagent kit upright in order to ensure complete finalization and rinsing during reagent change
availability of the microparticles during automatic mixing prior to use. ▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution
Stability: ▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
cups or pipette tips, waste bags
unopened at 2‑8 °C up to the stated expiration date
▪ 03023150001, WasteLiner, waste bags
after opening at 2‑8 °C 84 days (12 weeks)
▪ 03027651001, SysClean Adapter M
on the analyzers 28 days (4 weeks) Additional materials for all analyzers:
Specimen collection and preparation ▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
Only the specimens listed below were tested and found acceptable. 5 x 100 mL system cleaning solution
Serum collected using standard sampling tubes or tubes containing Assay
separating gel. For optimum performance of the assay follow the directions given in this
Li‑heparin, K2‑EDTA and K3‑EDTA plasma. document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions.
Plasma tubes containing separating gel can be used.
Resuspension of the microparticles takes place automatically prior to use.
Criterion: Slope 0.9‑1.1 + intercept within ≤ ± 0.04 ng/mL + coefficient of Read in the test-specific parameters via the reagent barcode. If in
correlation ≥ 0.95. exceptional cases the barcode cannot be read, enter the 15-digit sequence
Stable for 14 days at 15‑25 °C, 14 days at 2‑8 °C, 24 months at of numbers.
‑20 °C (± 5 °C). Freeze only once. cobas e 601 and cobas e 602 analyzers: PreClean M solution is
The sample types listed were tested with a selection of sample collection necessary.
tubes that were commercially available at the time of testing, i.e. not all Bring the cooled reagents to approximately 20 °C and place on the reagent
available tubes of all manufacturers were tested. Sample collection systems disk (20 °C) of the analyzer. Avoid foam formation. The system
from various manufacturers may contain differing materials which could automatically regulates the temperature of the reagents and the
affect the test results in some cases. When processing samples in primary opening/closing of the bottles.
tubes (sample collection systems), follow the instructions of the tube
manufacturer. Calibration
Centrifuge samples containing precipitates before performing the assay. Traceability: This method has been standardized against CRM (Certified
Do not use heat‑inactivated samples. Reference Material) 457, of the BCR (Community Bureau of Reference) of
the European Union.25

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Elecsys Tg II
Every Elecsys reagent set has a barcoded label containing specific Drug Concentration (μg/mL)
information for calibration of the particular reagent lot. The predefined
master curve is adapted to the analyzer using the relevant CalSet. Thiamazole 80
Calibration frequency: Calibration must be performed once per reagent lot Propylthiouracil 300
using fresh reagent (i.e. not more than 24 hours since the reagent kit was Perchlorate 2000
registered on the analyzer).
Calibration interval may be extended based on acceptable verification of Propranolol 240
calibration by the laboratory. Amiodarone 200
Renewed calibration is recommended as follows: Prednisolone 100
▪ after 1 month (28 days) when using the same reagent lot Hydrocortisone 200
▪ after 7 days (when using the same reagent kit on the analyzer) Fluocortolone 100
▪ as required: e.g. quality control findings outside the defined limits
Octreotide 0.3
Quality control
L-T3 0.5
Use PreciControl Universal, PreciControl Thyro Sensitive or other suitable
controls for routine quality control procedures. D-T3 0.5
Controls for the various concentration ranges should be run individually at L-T4 5
least once every 24 hours when the test is in use, once per reagent kit, and
following each calibration. D-T4 5
The control intervals and limits should be adapted to each laboratory’s Drug interferences are measured based on recommendations given in CLSI
individual requirements. Values obtained should fall within the defined guidelines EP07 and EP37 and other published literature. Effects of
limits. Each laboratory should establish corrective measures to be taken if concentrations exceeding these recommendations have not been
values fall outside the defined limits. characterized.
If necessary, repeat the measurement of the samples concerned. In rare cases, interference due to extremely high titers of antibodies to
Follow the applicable government regulations and local guidelines for analyte‑specific antibodies, streptavidin or ruthenium can occur. These
quality control. effects are minimized by suitable test design.
Calculation Tg determinations can be affected by the presence of anti‑thyroglobulin
antibodies (anti‑Tg) or by non-specific effects in patient sera. Results
The analyzer automatically calculates the analyte concentration of each should be preferably verified by the determination of anti‑Tg (e.g. Elecsys
sample (either in ng/mL or µg/L). Anti‑Tg assay).1,2
Interpretation of the results cobas e 601 and cobas e 602 analyzers:
When interpreting the test results the possibility of anti‑Tg antibodies in the Make sure that in the Special Wash List (Screen → Utility → Special Wash
sample should be taken into account. Results should be preferably verified → Immune) the Elecsys Tg II assay is combined with Anti‑Tg.
by the determination of anti‑Tg (e.g. Elecsys Anti‑Tg assay).1,2
Limitations - interference From test Step To test Step 0 Step 1 Step 2
The effect of the following endogenous substances and pharmaceutical Anti-Tg 1 Tg II - x -
compounds on assay performance was tested. Interferences were tested
up to the listed concentrations and no impact on results was observed. The described additions to the Special Wash List have to be entered
manually. Please refer to the operator's manual.
Endogenous substances For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other
Compound Concentration tested findings.
Bilirubin ≤ 1128 µmol/L or ≤ 66 mg/dL Limits and ranges
Hemoglobin ≤ 0.373 mmol/L or ≤ 600 mg/dL Measuring range
Intralipid ≤ 2000 mg/dL 0.04‑500 ng/mL (defined by the Limit of Detection and the maximum of the
master curve). Values below the Limit of Detection are reported as
Biotin ≤ 4912 nmol/L or ≤ 1200 ng/mL < 0.04 ng/mL. Values above the measuring range are reported as
Rheumatoid factors ≤ 600 IU/mL > 500 ng/mL (or up to 5000 ng/mL for 10‑fold diluted samples).
IgG ≤ 2 g/dL Lower limits of measurement
Limit of Blank, Limit of Detection and Limit of Quantitation
IgA ≤ 1.6 g/dL
Limit of Blank = 0.02 ng/mL
IgM ≤ 0.5 g/dL Limit of Detection = 0.04 ng/mL
Criterion: For concentrations of 0.04‑2 ng/mL the deviation is ≤ 10 %. For Limit of Quantitation = 0.1 ng/mL
concentrations > 2 ng/mL the deviation is ≤ 25 %. The Limit of Blank, Limit of Detection and Limit of Quantitation were
There is no high-dose hook effect at Tg concentrations up to determined in accordance with the CLSI (Clinical and Laboratory Standards
120000 ng/mL. Institute) EP17‑A2 requirements.
Pharmaceutical substances The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of
In vitro tests were performed on 17 commonly used pharmaceuticals. No analyte‑free samples over several independent series. The Limit of Blank
interference with the assay was found. corresponds to the concentration below which analyte‑free samples are
The following special drugs were tested with concentrations shown in the found with a probability of 95 %.
table below. No interference with the assay was found. The Limit of Detection is determined based on the Limit of Blank and the
Criterion: Recovery within ± 10 % of initial value. standard deviation of low concentration samples. The Limit of Detection
corresponds to the lowest analyte concentration which can be detected
Drug Concentration (μg/mL) (value above the Limit of Blank with a probability of 95 %).
Iodide 0.2 The Limit of Quantitation is the lowest analyte concentration that can be
reproducibly measured with an intermediate precision CV of ≤ 20 %.
Carbimazole 30

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Elecsys Tg II
When reporting results below Limit of Quantitation a higher uncertainty Method comparison
needs to be taken into consideration. A comparison of the Elecsys Tg II assay, 08906556190 (cobas e 601
Dilution analyzer; y), with the Elecsys Tg II assay, 06445896190 (cobas e 601
analyzer; x), gave the following correlations (ng/mL):
Samples with Tg concentrations above the measuring range can be diluted
with Diluent MultiAssay. The recommended dilution is 1:10 (either Number of samples measured: 142
automatically by the analyzers or manually). The concentration of the
diluted sample must be ≥ 40 ng/mL. Passing/Bablok26 Linear regression
After manual dilution, multiply the result by the dilution factor. y = 0.971x - 0.021 y = 0.970x - 0.077
After dilution by the analyzers, the software automatically takes the dilution τ = 0.977 r = 0.999
into account when calculating the sample concentration.
The sample concentrations were between 0.073 and 465 ng/mL.
Expected values
Analytical specificity
3.5-77 ng/mL
The following cross-reactivities were found, tested with thyroglobulin
These values correspond to the 2.5th and 97.5th percentiles of results concentrations of approximately 5 and 50 ng/mL:
obtained from a total of 478 healthy Caucasian subjects (254 males,
224 females). Cross-reactant Concentration tested Cross-reactivity
Each laboratory should investigate the transferability of the expected values %
to its own patient population and if necessary determine its own reference
ranges. TSH 1000 mIU/L not detectable
Specific performance data TBG 200000 ng/mL not detectable
Representative performance data on the analyzers are given below. References
Results obtained in individual laboratories may differ.
1 Erali M, Bigelow RB, Meikle AW. ELISA for thyroglobulin in serum:
Precision recovery studies to evaluate autoantibody interference and reliability of
Precision was determined using Elecsys reagents, samples and controls in thyroglobulin values. Clin Chem 1996;42(5):766-770.
a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory Standards 2 Spencer CA, LoPresti JS. Technology Insigth: measuring thyroglobulin
Institute): 2 runs per day in duplicate each for 21 days (n = 84). The and thyroglobulin autoantibody in patients with differentiated thyroid
following results were obtained: cancers. Nat Clin Pract Endocrinol Metab 2008;4(4):223-233.
cobas e 411 analyzer 3 Clark P, Franklyn J. Can we interpret serum thyroglobulin results? Ann
Clin Biochem 2012;49:313–322.
Repeatability Intermediate
4 Malthiéry Y, Lissitzky S. Primary structure of human thyroglobulin
precision deduced from sequence of its 8448-base complementary DNA. Eur J
Sample Mean SD CV SD CV Biochem 1987;165:491-498.
ng/mL ng/mL % ng/mL % 5 de Vijlder JJM, Ris-Stalpers C, Vulsma T. On the origin of circulating
Human serum 1 0.145 0.009 5.9 0.013 8.7 thyroglobulin. Eur J Endocrinol 1999 Jan;140(1):7-8.
6 Marinò M, McCluskey RT. Role of thyroglobulin endocytic pathways in
Human serum 2 2.03 0.047 2.3 0.059 2.9 the control of thyroid hormone release. Am J Physiol Cell Physiol 2000
Human serum 3 38.7 0.503 1.3 0.682 1.8 Nov;279(5):C1295-1306.
Human serum 4 235 4.52 1.9 5.37 2.3 7 Goodman HM. Thyroid Gland. In: Basic Medical Endocrinology,
Elsevier 4th Edition, 2008.
Human serum 5 459 7.76 1.7 10.2 2.2
8 Maurizis JC, Marriq C, Rolland M, et al. Thyroid hormone synthesis and
PCb) Universal 1 24.1 0.267 1.1 0.409 1.7 reactivity of hormone-forming tyrosine residues of thyroglobulin. FEBS
PC Universal 2 84.4 0.865 1.0 1.44 1.7 Lett 1981;132(1):29-32.
9 Luo Y, Kawashima A, Ishido Y, et al. Iodine excess as an
PC Thyro Sensitive 1.05 0.016 1.5 0.025 2.4 environmental risk factor for autoimmune thyroid disease. Int J Mol Sci
b) PC = PreciControl 2014;15:12895-12912.
cobas e 601 and cobas e 602 analyzers 10 Michalek K, Morshed SA, Latif R, et al. TSH receptor autoantibodies.
Autoimmun Rev 2009 Dec;9(2):113-116.
Repeatability Intermediate 11 Suzuki K, Kawashima A, Yoshihara A, et al. Role of thyroglobulin on
precision negative feedback autoregulation of thyroid follicular function and
Sample Mean SD CV SD CV growth. J Endocrinol 2011;209:169-174.
ng/mL ng/mL % ng/mL % 12 Kronenberg HM, Melmed S, Polonsky KS, et al. Williams Textbook of
Endocrinology. Saunders Elsevier, Philadelphia, 12th edition, 2011.
Human serum 1 0.141 0.006 4.0 0.006 4.4
13 Torréns JI, Burch HB. Serum thyroglobulin measurement. Utility in
Human serum 2 1.98 0.064 3.2 0.064 3.2 clinical practice. Endocrinol Metab Clin North Am 2001;30(2):429-467.
Human serum 3 38.8 0.696 1.8 0.857 2.2 14 Pacini F, Pinchera A. Serum and tissue thyroglobulin measurement:
Human serum 4 240 6.16 2.6 6.59 2.7 Clinical applications in thyroid disease. Biochemie 1999;81:463-467.
15 Davies L, Welch HG. Current thyroid cancer trends in the United
Human serum 5 461 10.2 2.2 11.9 2.6 States. JAMA Otolaryngol Head Neck Surg. 2014 Apr;140(4):317-22.
PC Universal 1 24.7 0.455 1.8 0.582 2.4 16 Spencer C, LoPresti J, Fatemi S. How sensitive (second-generation)
PC Universal 2 86.4 1.20 1.4 1.66 1.9 thyroglobulin measurement is changing paradigms for monitoring
patients with differentiated thyroid cancer, in the absence or presence
PC Thyro Sensitive 1.01 0.022 2.2 0.026 2.6 of thyroglobulin autoantibodies. Curr Opin Endocrinol Diabetes Obes
2014 Oct;21(5):394-404.
17 Pacini F, Schlumberger M, Dralle H, et al. European consensus for the
management of patients with differentiated thyroid carcinoma of the
follicular epithelium. Eur J Endocrinol 2006;154:787–803.

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Elecsys Tg II
18 Cooper DS, Doherty GM, Haugen BR, et al. Revised American Thyroid
Association Management Guidelines for Patients with Thyroid Nodules
and Differentiated Thyroid Cancer. Thyroid 2009;19(11):1-48.
Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
19 Pitoia F, Ward L, Wohllk N, et al. Recommendations of the Latin www.roche.com
American Thyroid Society on diagnosis and management of +800 5505 6606
differentiated thyroid cancer. Arq Bras Endocrinol Metab
2009;53(7):884-897.
20 Mazzaferri EL, Robbins RJ, Spencer CA, et al. A Consensus Report of
the Role of Serum Thyroglobulin as a Monitoring Method for Low-Risk
Patients with Papillary Thyroid Carcinoma. J Clin Endocrinol Metab
2003;88:1433-1441.
21 Zucchelli G, Iervasi A, Ferdeghini M, et al. Serum thyroglobulin
measurement in the follow-up of patients treated for differentiated
thyroid cancer. Q J Nucl Med Mol Imaging 2009;53:482-489.
22 Elisei R, Pinchera A. Advances in the follow-up of differentiated or
medullary thyroid cancer. A Nat Rev Endocrinol 2012;8:466-475.
23 Giovanella L, Clark PM, Chiovato L, et al. Thyroglobulin measurement
using highly sensitive assays in patients with differentiated thyroid
cancer: a clinical position paper. Eur J Endocrinol 2014;171(2):33-46.
24 Giovanella L, Feldt-Rasmussen U, Verburg FA, et al. Thyroglobulin
measurement by highly sensitive assays: focus on laboratory
challenges. Clin Chem Lab Med 2014 doi: 10.1515/cclm-2014-0813.
25 Feldt-Rasmussen U, Profilis C, Colinet E, et al. Purification and
assessment of stability and homogeneity of human thyroglobulin
reference material (CRM 457). Exp Clin Endocrinol 1994;102:87-91.
26 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
for method comparison studies in clinical chemistry, Part III.
J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
For further information, please refer to the appropriate user guide or
operator’s manual for the analyzer concerned, the respective application
sheets and the Method Sheets of all necessary components (if available in
your country).
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
The Summary of Safety & Performance Report can be found here:
https://ec.europa.eu/tools/eudamed
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see
navifyportal.roche.com for definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume for reconstitution
GTIN Global Trade Item Number

Rx only For USA: Caution: Federal law restricts this device to

sale by or on the order of a physician.
COBAS, NAVIFY, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
Fresenius Kabi AB.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2024, Roche Diagnostics

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