09005803500V3.

Elecsys FT3 III

cobas e 411
09005803190 09005803500 200 cobas e 601
cobas e 602

English R1 Anti‑T3‑Ab~Ru(bpy) (gray cap), 1 bottle, 18 mL:

System information Monoclonal anti‑T3‑antibody (sheep) labeled with ruthenium
For cobas e 411 analyzer: test number 2450 complex 18 ng/mL; phosphate buffer 100 mmol/L, pH 7.0;
For cobas e 601 and cobas e 602 analyzers: Application Code preservative.
Number 813
R2 T3~biotin (black cap), 1 bottle, 18 mL:
Intended use Biotinylated T3 2.4 ng/mL; phosphate buffer 100 mmol/L, pH 7.0;
Immunoassay for the in vitro quantitative determination of free preservative.
triiodothyronine in human serum and plasma.
The electrochemiluminescence immunoassay “ECLIA” is intended for use Precautions and warnings
on cobas e immunoassay analyzers. For in vitro diagnostic use for health care professionals. Exercise the
normal precautions required for handling all laboratory reagents.
Summary
Infectious or microbial waste:
Free triiodothyronine (fT3) measurements, performed with this assay, in Warning: handle waste as potentially biohazardous material. Dispose of
human serum and plasma are used as an aid in diagnosis of thyroid waste according to accepted laboratory instructions and procedures.
disorders.
Environmental hazards:
The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are secreted Apply all relevant local disposal regulations to determine the safe disposal.
into the bloodstream by the thyroid gland and play a vital role in regulating
the body's metabolic rate, influencing the cardiovascular system, growth Safety data sheet available for professional user on request.
and bone metabolism, and are important for normal development of This kit contains components classified as follows in accordance with the
gonadal functions and nervous system.1 Regulation (EC) No. 1272/2008:
T3 circulates in the bloodstream as an equilibrium mixture of free and
serum-bound hormone. FT3 is the unbound and biologically active form,
which represents only about 0.3 % of the total T3. The remaining T3 is
inactive and bound to serum proteins such as thyroxine-binding globulin
(TBG), thyroxine-binding prealbumin or transthyretin (TTR) and albumin.2
The determination of fT3 has the advantage of being independent of Warning
changes in the concentrations and binding properties of the binding
proteins; additional determination of a binding parameter (T‑uptake, TBG) is H317 May cause an allergic skin reaction.
therefore unnecessary. FT3 is a useful tool in clinical routine diagnostics for
the assessment of the thyroid status.3 FT3 measurements support the Prevention:
differential diagnosis of thyroid disorders, such as to define the degree of P261 Avoid breathing mist or vapours.
hyperthyroidism, to distinguish overt hyperthyroidism (low serum TSH levels
and high concentrations of thyroid hormones) from subclinical
hyperthyroidism (low TSH levels and normal concentrations of thyroid P272 Contaminated work clothing should not be allowed out of
hormones) or to identify patients with T3 thyrotoxicosis (low TSH levels, the workplace.
high levels T3, normal levels of T4).2,4,5,6
A variety of methods are available for estimating the free thyroid hormone P280 Wear protective gloves.
levels.2,3 In the Elecsys FT3 III assay a specific anti‑T3 antibody labeled Response:
with a ruthenium complexa) is used to determine the fT3 concentration.
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) ) P333 + P313 If skin irritation or rash occurs: Get medical
advice/attention.
Test principle
Competition principle. Total duration of assay: 18 minutes. P362 + P364 Take off contaminated clothing and wash it before reuse.
▪ 1st incubation: 15 µL of sample and an anti‑T3‑specific antibody labeled Disposal:
with a ruthenium complex.
▪ 2nd incubation: After addition of biotinylated T3 and streptavidin‑coated P501 Dispose of contents/container to an approved waste
microparticles, the still‑free binding sites of the labeled antibody become disposal plant.
occupied, with formation of an antibody‑hapten complex. The entire
complex is bound to the solid phase via interaction of biotin and Product safety labeling follows EU GHS guidance.
streptavidin. Contact phone: all countries: +49-621-7590
▪ The reaction mixture is aspirated into the measuring cell where the Avoid foam formation in all reagents and sample types (specimens,
microparticles are magnetically captured onto the surface of the calibrators and controls).
electrode. Unbound substances are then removed with Reagent handling
ProCell/ProCell M. Application of a voltage to the electrode then induces
chemiluminescent emission which is measured by a photomultiplier. The reagents in the kit have been assembled into a ready‑for‑use unit that
cannot be separated.
▪ Results are determined via a calibration curve which is instrument- All information required for correct operation is read in from the respective
specifically generated by 2‑point calibration and a master curve provided reagent barcodes.
via the reagent barcode or e‑barcode.
Reagents - working solutions Storage and stability
The reagent rackpack is labeled as FT3 3. Store at 2‑8 °C.
Do not freeze.
M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Store the Elecsys reagent kit upright in order to ensure complete
Streptavidin-coated microparticles 0.72 mg/mL; preservative. availability of the microparticles during automatic mixing prior to use.

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Elecsys FT3 III

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 42 days (6 weeks) onboard Additional materials for all analyzers:
or
56 days (8 weeks) when stored ▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
5 x 100 mL system cleaning solution
alternatively in the refrigerator and
on the analyzer, with the total time Assay
onboard on the analyzer not For optimum performance of the assay follow the directions given in this
document for the analyzer concerned. Refer to the appropriate operator’s
exceeding 120 hours manual for analyzer‑specific assay instructions.
Specimen collection and preparation Resuspension of the microparticles takes place automatically prior to use.
Only the specimens listed below were tested and found acceptable. Read in the test-specific parameters via the reagent barcode. If in
exceptional cases the barcode cannot be read, enter the 15-digit sequence
Undiluted serum collected using standard sampling tubes or tubes of numbers.
containing separating gel.
cobas e 601 and cobas e 602 analyzers: PreClean M solution is
Undiluted Li‑heparin, K2‑EDTA and K3‑EDTA plasma. necessary.
Criterion: Slope 0.9‑1.1 + intercept within ≤ ± 0.8 pmol/L + coefficient of Bring the cooled reagents to approximately 20 °C and place on the reagent
correlation ≥ 0.95. disk (20 °C) of the analyzer. Avoid foam formation. The system
Stable for 5 days at 20‑25 °C, 7 days at 2‑8 °C, 30 days at ‑20 °C (± 5 °C). automatically regulates the temperature of the reagents and the
Freeze only once. opening/closing of the bottles.
The sample types listed were tested with a selection of sample collection Calibration
tubes that were commercially available at the time of testing, i.e. not all Traceability: This method has been standardized against the Elecsys FT3
available tubes of all manufacturers were tested. Sample collection systems assay ( 03051986190). The Elecsys FT3 assay ( 03051986190) is
from various manufacturers may contain differing materials which could traceable to the Elecsys FT3 assay ( 11731386122) which was
affect the test results in some cases. When processing samples in primary standardized using equilibrium dialysis.7,8
tubes (sample collection systems), follow the instructions of the tube
manufacturer. Every Elecsys reagent set has a barcoded label containing specific
information for calibration of the particular reagent lot. The predefined
Centrifuge samples containing precipitates before performing the assay. master curve is adapted to the analyzer using the relevant CalSet.
Do not use heat‑inactivated samples. Calibration frequency: Calibration must be performed once per reagent lot
Do not use samples and controls stabilized with azide. using fresh reagent (i.e. not more than 24 hours since the reagent kit was
Ensure the samples, calibrators and controls are at 20‑25 °C prior to registered on the analyzer).
measurement. Calibration interval may be extended based on acceptable verification of
Due to possible evaporation effects, samples, calibrators and controls on calibration by the laboratory.
the analyzers should be analyzed/measured within 2 hours. Renewed calibration is recommended as follows:
Materials provided ▪ after 1 month (28 days) when using the same reagent lot
See “Reagents – working solutions” section for reagents. ▪ after 7 days (when using the same reagent kit on the analyzer)
Materials required (but not provided) ▪ as required: e.g. quality control findings outside the defined limits
▪ 09077871190, FT3 III CalSet, for 4 x 1.0 mL Quality control
▪ 11731416190, PreciControl Universal, for 4 x 3.0 mL For quality control, use PreciControl Universal.
▪ General laboratory equipment In addition, other suitable control material can be used.
▪ cobas e analyzer Controls for the various concentration ranges should be run individually at
Additional materials for the cobas e 411 analyzer: least once every 24 hours when the test is in use, once per reagent kit, and
following each calibration.
▪ 11662988122, ProCell, 6 x 380 mL system buffer The control intervals and limits should be adapted to each laboratory’s
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning individual requirements. Values obtained should fall within the defined
solution limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits.
▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
If necessary, repeat the measurement of the samples concerned.
▪ 11933159001, Adapter for SysClean
Follow the applicable government regulations and local guidelines for
▪ 11706802001, AssayCup, 60 x 60 reaction cups quality control.
▪ 11706799001, AssayTip, 30 x 120 pipette tips Calculation
▪ 11800507001, Clean‑Liner The analyzer automatically calculates the analyte concentration of each
Additional materials for cobas e 601 and cobas e 602 analyzers: sample (either in pmol/L, pg/mL or ng/dL).
▪ 04880340190, ProCell M, 2 x 2 L system buffer Conversion factors: pmol/L x 0.651 = pg/mL
▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning pg/mL x 1.536 = pmol/L
solution pg/mL x 0.1 = ng/dL
▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
CleanCell M before use Limitations - interference
The effect of the following endogenous substances and pharmaceutical
▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run compounds on assay performance was tested. Interferences were tested
finalization and rinsing during reagent change up to the listed concentrations and no impact on results was observed.
▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution

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Elecsys FT3 III

Endogenous substances 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
Compound Concentration tested corresponds to the concentration below which analyte‑free samples are
Bilirubin ≤ 1128 µmol/L or ≤ 66 mg/dL found with a probability of 95 %.
Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL The Limit of Detection is determined based on the Limit of Blank and the
standard deviation of low concentration samples. The Limit of Detection
Intralipid ≤ 2000 mg/dL corresponds to the lowest analyte concentration which can be detected
(value above the Limit of Blank with a probability of 95 %).
Biotin ≤ 4912 nmol/L or ≤ 1200 ng/mL
The Limit of Quantitation is the lowest analyte concentration that can be
Rheumatoid factors ≤ 1200 IU/mL reproducibly measured with an intermediate precision CV of ≤ 20 %.
IgG ≤ 7 g/dL Dilution
IgA ≤ 1.6 g/dL Samples for fT3 determinations cannot be diluted, as T3 in the blood is
present in free and protein-bound forms which are in equilibrium. A change
IgM ≤ 1 g/dL in the concentration of the binding proteins alters this equilibrium.
Criterion: Recovery of ± 0.4 pmol/L of initial value ≤ 4 pmol/L and ± 10 % of Expected values
initial value > 4 pmol/L. Euthyroid: 3.1‑6.8 pmol/L (2.0‑4.4 pg/mL)
Any influence that might affect the binding behavior of the binding proteins These values correspond to the 2.5th and 97.5th percentiles of results
can alter the result of the fT3 tests (e.g. drugs, NTIs (Non‑Thyroid‑Illness) or obtained from a total of 5366 healthy test subjects examined.
patients suffering from FDH (Familial Dysalbuminemic
Hyperthyroxinemia)).9,10 For detailed information about reference intervals in children, adolescents
and pregnant women, refer to the brochure “Reference Intervals for
Pharmaceutical substances Children and Adults”, English: 04640292.
In vitro tests were performed on 17 commonly used pharmaceuticals. No
interference with the assay was found. This booklet also contains results of a detailed study about influencing
factors on thyroid parameters in a well characterized reference group of
In addition, the following special thyroid drugs were tested. No interference adults. Different inclusion and exclusion criteria were applied (e.g.
with the assay was found. sonographic results (thyroid volume and density) as well as criteria
Special thyroid drugs according to the guidelines of the National Academy of Clinical
Biochemistry - NACB).
Drug Concentration tested Each laboratory should investigate the transferability of the expected values
µg/mL to its own patient population and if necessary determine its own reference
Iodide 0.200 ranges.
Carbimazole 30 Specific performance data
Representative performance data on the analyzers are given below.
Thiamazole 80 Results obtained in individual laboratories may differ.
Propylthiouracil 60 Precision
Perchlorate 2000 Precision was determined using Elecsys reagents, samples and controls in
a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory Standards
Propranolol 240 Institute): 2 runs per day in duplicate each for 21 days (n = 84). The
Amiodarone 200 following results were obtained:
Prednisolone 100 cobas e 411 analyzer
Hydrocortisone 200 Repeatability Intermediate
Fluocortolone 100 precision
Octreotide 0.300 Sample Mean SD CV SD CV
pmol/L pmol/L % pmol/L %
In in vitro studies the drugs furosemide, liothyronine and levothyroxine
caused elevated fT3 findings at the daily therapeutic dosage level. Human serum 1 1.64 0.064 3.9 0.096 5.8
In rare cases, interference due to extremely high titers of antibodies to Human serum 2 3.54 0.067 1.9 0.115 3.2
analyte‑specific antibodies, streptavidin or ruthenium can occur. These
effects are minimized by suitable test design. Human serum 3 7.08 0.103 1.4 0.172 2.4
For diagnostic purposes, the results should always be assessed in Human serum 4 25.7 0.400 1.6 0.472 1.8
conjunction with the patient’s medical history, clinical examination and other Human serum 5 48.0 0.396 0.8 0.551 1.1
findings.
PreciControl Ub)1 5.33 0.082 1.5 0.115 2.2
Limits and ranges
Measuring range PC U2 22.9 0.366 1.6 0.454 2.0
0.6‑50 pmol/L (defined by the Limit of Detection and the maximum of the b) U = Universal
master curve). Values below the Limit of Detection are reported as
< 0.6 pmol/L. Values above the measuring range are reported as cobas e 601 and cobas e 602 analyzers
> 50 pmol/L. Repeatability Intermediate
Lower limits of measurement precision
Limit of Blank, Limit of Detection and Limit of Quantitation Sample Mean SD CV SD CV
Limit of Blank = 0.4 pmol/L pmol/L pmol/L % pmol/L %
Limit of Detection = 0.6 pmol/L
Human serum 1 1.64 0.067 4.1 0.081 5.0
Limit of Quantitation = 1.5 pmol/L
Human serum 2 3.57 0.075 2.1 0.089 2.5
The Limit of Blank, Limit of Detection and Limit of Quantitation were
determined in accordance with the CLSI (Clinical and Laboratory Standards Human serum 3 7.24 0.100 1.4 0.131 1.8
Institute) EP17‑A2 requirements.

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Elecsys FT3 III

cobas e 601 and cobas e 602 analyzers 8 Ekins RP, Ellis SM. The radioimmunoassay of free thyroid hormones in
serum. In Robbins J, Braverman LE (eds). Thyroid research,
Repeatability Intermediate Proceedings of the Seventh International Thyroid Conference, Boston.
precision Amsterdam, Excerpta Medica 1975:597.
Sample Mean SD CV SD CV 9 Wada N, Chiba H, Shimizu C, et al. A novel missense mutation in
pmol/L pmol/L % pmol/L % codon 218 of the albumin gene in a distinct phenotype of familial
dysalbuminemic hyperthyroxinemia in a Japanese kindred. J Clin
Human serum 4 25.9 0.324 1.3 0.398 1.5 Endocrinol Metab 1997;82(10):3246-3250.
Human serum 5 46.8 0.386 0.8 0.426 0.9 10 Arevalo G. Prevalence of familial dysalbuminemic hyperthyroxinemia in
PreciControl U1 5.39 0.098 1.8 0.115 2.1 serum samples received for thyroid testing. Clin Chem
1991;37(8):1430-1431.
PreciControl U2 22.9 0.268 1.2 0.365 1.6
11 Bablok W, Passing H, Bender R, et al. A general regression procedure
Method comparison for method transformation. Application of linear regression procedures
A comparison of the Elecsys FT3 III assay, 09005803190 for method comparison studies in clinical chemistry, Part III.
(cobas e 601 analyzer; y) with the Elecsys FT3 III assay, J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
06437206190 (cobas e 601 analyzer; x) gave the following For further information, please refer to the appropriate operator’s manual for
correlations (pmol/L): the analyzer concerned, the respective application sheets and the Method
Number of samples measured: 179 Sheets of all necessary components (if available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
Passing/Bablok11 Linear regression separator to mark the border between the integral and the fractional parts of
y = 0.999x - 0.001 y = 0.983x + 0.200 a decimal numeral. Separators for thousands are not used.
Any serious incident that has occurred in relation to the device shall be
τ = 0.976 r = 0.999 reported to the manufacturer and the competent authority of the Member
The sample concentrations were between 1.46 and 49.9 pmol/L. State in which the user and/or the patient is established.
Analytical specificity Symbols
The following cross-reactivities were found, tested with fT3 concentrations Roche Diagnostics uses the following symbols and signs in addition to
of approximately 4.61 pmol/L (3.00 pg/mL) and 11.4 pmol/L (7.44 pg/mL): those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Cross-reactant Concentration Cross-reactivity
tested % Contents of kit
pg/mL Analyzers/Instruments on which reagents can be used
L‑T4 300000 0.009 Reagent
D‑T4 625000 0.005 Calibrator
rT3 10000000 0.000 Volume for reconstitution
3‑iodo‑L‑tyrosine 100000000 0.000
GTIN Global Trade Item Number
3,5‑diiodo‑L‑tyrosine 100000000 0.000
COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
3,3’,5‑triiodothyroacetic acid 6250 0.298 Fresenius Kabi AB.
3,3’,5,5’‑tetraiodothyroacetic 1000000 0.000 All other product names and trademarks are the property of their respective owners.
acid Additions, deletions or changes are indicated by a change bar in the margin.
© 2023, Roche Diagnostics
References
1 Kronenberg HM, Melmed S, Polonsky KS, et al. Williams Textbook of
Endocrinology. Saunders Elsevier, Philadelphia, 12th edition, 2011,
chapter 10, p. 301-311. Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
www.roche.com
2 Ellervik C, Halsall DJ, Nygaard B. Thyroid Disorders. In: Rifai N, Chiu
RWK, Young I, Burnham CAD, Wittwer CT, editors. Tietz Textbook of +800 5505 6606
Laboratory Medicine, Saunders Elsevier, Philadelphia, 7th edition,
2023, chapter 57, p. 806-845.e13.
3 Brent GA. Thyroid Function Testing. Springer, Berlin, 1st edition, 2010,
chapter 5, p. 86-88.
4 Kahaly GJ, Bartalena L, Hegedüs L, et al. 2018 European Thyroid
Association Guideline for the Management of Graves' Hyperthyroidism.
Eur Thyroid J 2018 Aug;7(4):167-186. doi: 10.1159/000490384.
5 Bartalena L, Bogazzi F, Chiovato L, et al. 2018 European Thyroid
Association (ETA) Guidelines for the Management of Amiodarone-
Associated Thyroid Dysfunction. Eur Thyroid J 2018 Mar;7(2):55-66.
doi: 10.1159/000486957.
6 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.
7 Ekins RP. Measurement of free hormones in blood. Endocr Rev
1990;11(1):5-46.

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