08443432500V6.

Elecsys TSH
08443432190* cobas e 402
08443432500 300
08443432214* cobas e 801
* Some kits shown may not be available in all countries.

English M Streptavidin-coated microparticles, 1 bottle, 14.1 mL:

System information Streptavidin-coated microparticles 0.72 mg/mL; preservative.
R1 Anti-TSH-Ab~biotin, 1 bottle, 15.8 mL:
Short name ACN (application code number)
Biotinylated monoclonal anti‑TSH antibody (mouse) 2.0 mg/L;
TSH 10172 phosphate buffer 100 mmol/L, pH 7.2; preservative.
Intended use R2 Anti-TSH-Ab~Ru(bpy) , 1 bottle, 13.9 mL:
Immunoassay for the in vitro quantitative determination of thyrotropin in Monoclonal anti‑TSH antibody (mouse/human) labeled with
human serum and plasma. ruthenium complex 1.5 mg/L; phosphate buffer 100 mmol/L, pH 7.2;
The electrochemiluminescence immunoassay “ECLIA” is intended for use preservative.
on cobas e immunoassay analyzers.
Precautions and warnings
Summary
For in vitro diagnostic use for health care professionals. Exercise the
Thyroid‑stimulating hormone (TSH, thyrotropin) measurements, performed normal precautions required for handling all laboratory reagents.
with this assay, in human serum and plasma are used as an aid in
diagnosis of hypothalamic-pituitary-thyroid (HPT) disorders. Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of
TSH is a glycoprotein consisting of 2 subunits. The β‑subunit is critical for waste according to accepted laboratory instructions and procedures.
the heterodimer assembly and its biological activity. The α‑chain is common
to the follicle-stimulating hormone (FSH), luteinizing hormone (LH), and Environmental hazards:
human chorionic gonadotropin (hCG).1 Apply all relevant local disposal regulations to determine the safe disposal.
TSH is formed in specific basophil cells of the anterior pituitary and is Safety data sheet available for professional user on request.
subject to a circadian secretion sequence. The hypophyseal synthesis and This kit contains components classified as follows in accordance with the
release of TSH is stimulated by the thyrotropin-releasing hormone (TRH). Regulation (EC) No. 1272/2008:
TSH binding to the TSH receptor results in the production of the thyroid
hormones triiodothyronine (T3) and thyroxine (T4). T3 and T4 in turn
regulate the TSH and TRH levels via a negative feedback loop. Small
changes in the concentrations of free T3 and/or T4 will result in significant
large changes in TSH concentrations.2
The determination of TSH serves as the initial test to assess thyroid
function. In case of high levels of TSH, free thyroxine (fT4) measurements Warning
are performed to determine the degree of hypothyroidism. When low levels H317 May cause an allergic skin reaction.
of TSH are measured, fT4 and free triiodothyronine (fT3) measurements
are performed to determine the degree of hyperthyroidism. TSH Prevention:
measurements are particularly suitable for early detection or exclusion of
disorders in the central regulating circuit between the hypothalamus, P261 Avoid breathing mist or vapours.
pituitary and thyroid. In case of suspected pituitary or hypothalamic disease,
TSH levels are measured together with fT4 levels to confirm diagnosis.3,4,5,6 P272 Contaminated work clothing should not be allowed out of
The Elecsys TSH assay employs monoclonal antibodies specifically the workplace.
directed against human TSH. The antibodies labeled with ruthenium
complexa) consist of a chimeric construct from human and mouse‑specific P280 Wear protective gloves.
components. As a result, interfering effects due to HAMA (human
anti‑mouse antibodies) are largely eliminated. Response:
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) ) P333 + P313 If skin irritation or rash occurs: Get medical
Test principle advice/attention.
Sandwich principle. Total duration of assay: 18 minutes.
P362 + P364 Take off contaminated clothing and wash it before reuse.
▪ 1st incubation: 30 µL of sample, a biotinylated monoclonal TSH‑specific
antibody and a monoclonal TSH‑specific antibody labeled with a Disposal:
ruthenium complex react to form a sandwich complex.
P501 Dispose of contents/container to an approved waste
▪ 2nd incubation: After addition of streptavidin-coated microparticles, the disposal plant.
complex becomes bound to the solid phase via interaction of biotin and
streptavidin. Product safety labeling follows EU GHS guidance.
▪ The reaction mixture is aspirated into the measuring cell where the Contact phone: all countries: +49-621-7590
microparticles are magnetically captured onto the surface of the Avoid foam formation in all reagents and sample types (specimens,
electrode. Unbound substances are then removed with ProCell II M. calibrators and controls).
Application of a voltage to the electrode then induces chemiluminescent
emission which is measured by a photomultiplier. Reagent handling
The reagents in the kit have been assembled into a ready‑for‑use unit that
▪ Results are determined via a calibration curve which is instrument- cannot be separated.
specifically generated by 2‑point calibration and a master curve provided
via the cobas link. All information required for correct operation is available via the cobas link.
Reagents - working solutions Storage and stability
The cobas e pack is labeled as TSH. Store at 2‑8 °C.
Do not freeze.

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Elecsys TSH
Store the cobas e pack upright in order to ensure complete availability of Place the cooled (stored at 2‑8 °C) cobas e pack on the reagent manager.
the microparticles during automatic mixing prior to use. Avoid foam formation. The system automatically regulates the temperature
of the reagents and the opening/closing of the cobas e pack.
Stability:
Calibration
unopened at 2‑8 °C up to the stated expiration date Traceability: This method has been standardized against the 2nd IRP WHO
on the analyzers 16 weeks Reference Standard 80/558.
The predefined master curve is adapted to the analyzer using the relevant
Specimen collection and preparation CalSet.
Only the specimens listed below were tested and found acceptable. Calibration frequency: Calibration must be performed once per reagent lot
Serum collected using standard sampling tubes or tubes containing using fresh reagent (i.e. not more than 24 hours since the cobas e pack
separating gel. was registered on the analyzer).
Li‑heparin, K2‑EDTA and K3‑EDTA plasma. Calibration interval may be extended based on acceptable verification of
Plasma tubes containing separating gel can be used. calibration by the laboratory.
Criterion: Slope 0.9‑1.1 + coefficient of correlation ≥ 0.95 and with a bias Renewed calibration is recommended as follows:
≤ 10 % at medical decision points (0.27 µIU/mL and 4.2 µIU/mL). ▪ after 12 weeks when using the same reagent lot
Stable for 8 days at 20‑25 °C, 14 days at 2‑8 °C, 24 months at ▪ after 28 days when using the same cobas e pack on the analyzer
‑20 °C (± 5 °C). Freeze only once.
▪ as required: e.g. quality control findings outside the defined limits
The sample types listed were tested with a selection of sample collection
tubes that were commercially available at the time of testing, i.e. not all Quality control
available tubes of all manufacturers were tested. Sample collection systems For quality control, use PreciControl Universal or PreciControl Thyro
from various manufacturers may contain differing materials which could Sensitive.
affect the test results in some cases. When processing samples in primary In addition, other suitable control material can be used.
tubes (sample collection systems), follow the instructions of the tube
manufacturer. Controls for the various concentration ranges should be run individually at
least once every 24 hours when the test is in use, once per cobas e pack,
Centrifuge samples containing precipitates before performing the assay. and following each calibration.
Do not use heat‑inactivated samples. The control intervals and limits should be adapted to each laboratory’s
Do not use samples and controls stabilized with azide. individual requirements. Values obtained should fall within the defined
Ensure the samples and calibrators are at 20‑25 °C prior to measurement. limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits.
Due to possible evaporation effects, samples and calibrators on the
analyzers should be analyzed/measured within 2 hours. If necessary, repeat the measurement of the samples concerned.
Materials provided Follow the applicable government regulations and local guidelines for
quality control.
See “Reagents – working solutions” section for reagents.
Calculation
Materials required (but not provided)
The analyzer automatically calculates the analyte concentration of each
▪ 08443459190, TSH CalSet, 4 x 1.3 mL sample either in µIU/mL or mIU/L (selectable).
▪ 06445918190, PreciControl Thyro Sensitive, for 4 x 2.0 mL Limitations - interference
▪ 11731416190, PreciControl Universal, for 4 x 3.0 mL The effect of the following endogenous substances and pharmaceutical
▪ 07299010190, Diluent MultiAssay, 36 mL sample diluent compounds on assay performance was tested. Interferences were tested
up to the listed concentrations and no impact on results was observed.
▪ General laboratory equipment
Endogenous substances
▪ cobas e analyzer
Additional materials for cobas e 402 and cobas e 801 analyzers: Compound Concentration tested
▪ 06908799190, ProCell II M, 2 x 2 L system solution Bilirubin ≤ 701 µmol/L or ≤ 41 mg/dL
▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL
solution
Intralipid ≤ 1500 mg/dL
▪ 07485409001, Reservoir Cup, 8 cups to supply ProCell II M and
CleanCell M Biotin ≤ 4912 nmol/L or ≤ 1200 ng/mL
▪ 06908853190, PreClean II M, 2 x 2 L wash solution Rheumatoid factors ≤ 1500 IU/mL
▪ 05694302001, Assay Tip/Assay Cup tray, 6 magazines IgG ≤ 2 g/dL
x 6 magazine stacks x 105 assay tips and 105 assay cups, 3 wasteliners IgM ≤ 0.5 g/dL
▪ 07485425001, Liquid Flow Cleaning Cup, 2 adaptor cups to supply
ISE Cleaning Solution/Elecsys SysClean for Liquid Flow Cleaning Criterion: For concentrations ≤ 0.2 µIU/mL the deviation is ≤ 0.02 µIU/mL.
Detection Unit For concentrations > 0.2 µIU/mL the deviation is ≤ 10 %.
▪ 07485433001, PreWash Liquid Flow Cleaning Cup, 1 adaptor cup There is no high-dose hook effect at TSH concentrations up to
to supply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow 1000 µIU/mL.
Cleaning PreWash Unit Pharmaceutical substances
In vitro tests were performed on 17 commonly used pharmaceuticals. No
▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean, interference with the assay was found.
5 x 100 mL system cleaning solution
In addition, the following special drugs were tested. No interference with the
Assay assay was found.
For optimum performance of the assay follow the directions given in this
document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions.
Resuspension of the microparticles takes place automatically prior to use.

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Special drugs Expected values
Drug Concentration tested 0.270-4.20 µIU/mL8
mg/L These values correspond to the 2.5th and 97.5th percentiles of results
obtained from a total of 516 healthy test subjects examined.
Iodide 0.2 For detailed information about reference intervals in children, adolescents
Carbimazole 30 and pregnant women, refer to the brochure “Reference Intervals for
Children and Adults”, English: 04640292.
Methimazole 80
This booklet also contains results of a detailed study about influencing
Propylthiouracil 60 factors on thyroid parameters in a well characterized reference group of
Perchlorate 2000 adults. Different inclusion and exclusion criteria were applied (e.g.
sonographic results (thyroid volume and density) as well as criteria
Propranolol 240 according to the guidelines of the National Academy of Clinical
Biochemistry - NACB).
Amiodarone 200
Each laboratory should investigate the transferability of the expected values
Prednisolone 100 to its own patient population and if necessary determine its own reference
Hydrocortisone 200 ranges.
Fluocortolone 100 Specific performance data
Representative performance data on the analyzers are given below.
Octreotide 0.3 Results obtained in individual laboratories may differ.
Levothyroxine 0.25 Precision
Liothyronine 0.015 Precision was determined using Elecsys reagents, samples and controls in
a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory Standards
Drug interferences are measured based on recommendations given in CLSI Institute): 2 runs per day in duplicate each for 21 days (n = 84). The
guidelines EP07 and EP37 and other published literature. Effects of following results were obtained:
concentrations exceeding these recommendations have not been
characterized. cobas e 402 and cobas e 801 analyzers
The presence of autoantibodies may induce high molecular weight
complexes (macro‑TSH) which may cause unexpectedly high values of Repeatability Intermediate
TSH.7 precision
In rare cases, interference due to extremely high titers of antibodies to Sample Mean SD CV SD CV
analyte‑specific antibodies, streptavidin or ruthenium can occur. These µIU/mL µIU/mL % µIU/mL %
effects are minimized by suitable test design.
Human serum 1 0.015 0.001 3.4 0.002 11.2
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other Human serum 2 0.281 0.003 1.1 0.005 1.8
findings. Human serum 3 4.09 0.030 0.7 0.090 2.2
Limits and ranges Human serum 4 59.8 0.494 0.8 1.10 1.8
Measuring range
Human serum 5 95.6 0.706 0.7 3.81 4.0
0.005‑100 µIU/mL (defined by the Limit of Detection and the maximum of
the master curve). Values below the Limit of Detection are reported as PCb) Universal 1 1.39 0.013 1.0 0.021 1.5
< 0.005 µIU/mL. Values above the measuring range are reported as
> 100 µIU/mL (or up to 1000 µIU/mL for 10‑fold diluted samples). PC Universal 2 7.99 0.064 0.8 0.132 1.6
Lower limits of measurement PC Thyro Sensitive 0.176 0.002 1.2 0.004 2.1
Limit of Blank, Limit of Detection and Limit of Quantitation b) PC = PreciControl
Limit of Blank = 0.0025 µIU/mL Method comparison
Limit of Detection = 0.005 µIU/mL a) A comparison of the Elecsys TSH assay, 08443432190
Limit of Quantitation = 0.005 µIU/mL (cobas e 801 analyzer; y), with the Elecsys TSH assay, 07028091190
(cobas e 801 analyzer; x), gave the following correlations (µIU/mL):
The Limit of Blank, Limit of Detection and Limit of Quantitation were
determined in accordance with the CLSI (Clinical and Laboratory Standards Number of samples measured: 138
Institute) EP17‑A2 requirements.
Passing/Bablok9 Linear regression
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of
analyte‑free samples over several independent series. The Limit of Blank y = 0.974x - 0.000 y = 0.944x + 0.089
corresponds to the concentration below which analyte‑free samples are τ = 0.972 r = 0.999
found with a probability of 95 %.
The Limit of Detection is determined based on the Limit of Blank and the The sample concentrations were between 0.006 and 99.2 µIU/mL.
standard deviation of low concentration samples. The Limit of Detection b) A comparison of the Elecsys TSH assay, 08443432190
corresponds to the lowest analyte concentration which can be detected (cobas e 402 analyzer; y), with the Elecsys TSH assay, 08443432190
(value above the Limit of Blank with a probability of 95 %). (cobas e 801 analyzer; x), gave the following correlations (µIU/mL):
The Limit of Quantitation is the lowest analyte concentration that can be Number of samples measured: 138
reproducibly measured with an intermediate precision CV of ≤ 20 %.
Passing/Bablok9 Linear regression
Dilution
Samples with TSH concentrations above the measuring range can be y = 0.972x - 0.003 y = 0.968x + 0.014
diluted with Diluent MultiAssay. The recommended dilution is 1:10 (either τ = 0.987 r = 1.00
automatically by the analyzers or manually). The concentration of the
diluted sample must be ≥ 10 µIU/mL. The sample concentrations were between 0.006 and 90.6 µIU/mL.
After manual dilution, multiply the result by the dilution factor. Analytical specificity
After dilution by the analyzers, the software automatically takes the dilution The following cross-reactivities were found, tested with a TSH concentration
into account when calculating the sample concentration. of approximately 0.35 µIU/mL.

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Elecsys TSH
Cross-reactant Concentration tested Cross-reactivity GTIN Global Trade Item Number
mU/mL %
COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
LH 10000 0.000 Fresenius Kabi AB.
All other product names and trademarks are the property of their respective owners.
FSH 10000 0.000
Additions, deletions or changes are indicated by a change bar in the margin.
hGH 1000 n. d.c) © 2023, Roche Diagnostics

hCG 50000 0.000

c) n. d. = not detectable
References Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
1 Ando H. Subchapter 23C - Thyroid-stimulating hormone. In: Ando H, www.roche.com
Ukena K, Nagata S, editors. Handbook of Hormones (Second Edition). +800 5505 6606
San Diego: Academic Press; 2021. p. 193-195.
2 Ellervik C, Halsall DJ, Nygaard B. Thyroid Disorders. In: Rifai N, Chiu
RWK, Young I, Burnham CAD, Wittwer CT, editors. Tietz Textbook of
Laboratory Medicine, Saunders Elsevier, Philadelphia, 7th edition,
2023, chapter 57, p. 806-845.e13.
3 Garber JR, Cobin RH, Gharib H, et al. American Association of Clinical
Endocrinologists and American Thyroid Association Taskforce on
Hypothyroidism in Adults. Clinical practice guidelines for
hypothyroidism in adults: cosponsored by the American Association of
Clinical Endocrinologists and the American Thyroid Association. Endocr
Pract. 2012 Nov-Dec;18(6):988-1028. doi: 10.4158/EP12280.GL.
Erratum in: Endocr Pract. 2013 Jan-Feb;19(1):175.
4 Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid
Association Guidelines for Diagnosis and Management of
Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016
Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229. Erratum in:
Thyroid. 2017 Nov;27(11):1462.
5 Persani L, Brabant G, Dattani M, et al. 2018 European Thyroid
Association (ETA) Guidelines on the Diagnosis and Management of
Central Hypothyroidism. Eur Thyroid J 2018 Oct;7(5):225-237. doi:
10.1159/000491388.
6 Urgatz B, Razvi S. Subclinical hypothyroidism, outcomes and
management guidelines: a narrative review and update of recent
literature. Curr Med Res Opin 2023 Mar;39(3):351-365. doi:
10.1080/03007995.2023.2165811.
7 Sakai H, Fukuda G, Suzuki N, et al. Falsely Elevated Thyroid-
Stimulating Hormone (TSH) Level Due to Macro-TSH.
Endocr J 2009;56(3):435-440.
8 Ebert C, Bieglmayer C, Igari J, et al. Elecsys TSH, FT4, T4, T-uptake,
FT3 and T3. Clinical results of a multicentre study. Wien Klin
Wochenschr 1998;110 Suppl 3:27-40.
9 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 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.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume for reconstitution

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