ms_06437206190V3.

Elecsys FT3 III

MODULAR ANALYTICS E170
cobas e 411
06437206 190 200
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 1240 complex 18 ng/mL; phosphate buffer 100 mmol/L, pH 7.0;
For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 preservative.
analyzers: Application Code Number 195
R2 T3~biotin (black cap), 1 bottle, 18 mL:
Intended use
Immunoassay for the in vitro quantitative determination of free Biotinylated T3 2.4 ng/mL; phosphate buffer 100 mmol/L, pH 7.0;
triiodothyronine in human serum and plasma. preservative.
The electrochemiluminescence immunoassay “ECLIA” is intended for use
on Elecsys and cobas e immunoassay analyzers. Precautions and warnings
For in vitro diagnostic use.
Summary Exercise the normal precautions required for handling all laboratory
The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are secreted reagents.
into the bloodstream by the thyroid gland and play a vital role in regulating Disposal of all waste material should be in accordance with local guidelines.
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 Avoid foam formation in all reagents and sample types (specimens,
gonadal functions and nervous system.1 calibrators and controls).
T3 circulates in the bloodstream as an equilibrium mixture of free and
serum bound hormone. Free T3 (fT3) is the unbound and biologically active Reagent handling
form, which represents only 0.2‑0.4 % of the total T3. The remaining T3 is The reagents in the kit have been assembled into a ready‑for‑use unit that
inactive and bound to serum proteins, while the distribution of T3 between cannot be separated.
these binding proteins (thyroxine binding globulin, pre-albumin, albumin) is All information required for correct operation is read in from the respective
controversially discussed.2,3,4,5 reagent barcodes.
The determination of free T3 has the advantage of being independent of Storage and stability
changes in the concentrations and binding properties of the binding Store at 2‑8 °C.
proteins; additional determination of a binding parameter (T‑uptake, TBG) is
therefore unnecessary. Therefore free T3 is a useful tool in clinical routine Do not freeze.
diagnostics for the assessment of the thyroid status. Free T3 Store the Elecsys reagent kit upright in order to ensure complete
measurements support the differential diagnosis of thyroid disorders, are availability of the microparticles during automatic mixing prior to use.
needed to distinguish different forms of hyperthyroidism, and to identify
patients with T3 thyrotoxicosis.1,6,7 Stability:
A variety of methods are available for estimating the free thyroid hormone unopened at 2‑8 °C up to the stated expiration date
levels. The direct measurement of fT4 and fT3 via equilibrium dialysis or
ultrafiltration is mainly used as a reference method for standardizing the after opening at 2‑8 °C 84 days (12 weeks)
immunological procedures generally used for routine diagnostic purposes.6,7 on the analyzers 42 days (6 weeks) onboard
In the Elecsys FT3 III assay a specific anti‑T3 antibody labeled with a or
ruthenium complexa) is used to determine the free triiodothyronine 56 days (8 weeks) when stored
concentration.
alternatively in the refrigerator and
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
on the analyzer, with the total time
Test principle onboard on the analyzer not
Competition principle. Total duration of assay: 18 minutes. exceeding 120 hours
▪ 1st incubation: 15 µL of sample and an anti‑T3‑specific antibody labeled
with a ruthenium complex. Specimen collection and preparation
Only the specimens listed below were tested and found acceptable.
▪ 2nd incubation: After addition of biotinylated T3 and streptavidin‑coated
microparticles, the still‑free binding sites of the labeled antibody become Undiluted serum collected using standard sampling tubes or tubes
occupied, with formation of an antibody‑hapten complex. The entire containing separating gel.
complex is bound to the solid phase via interaction of biotin and Undiluted Li‑heparin, K2‑EDTA and K3‑EDTA plasma.
streptavidin. Recovery with a total deviation ≤ ± 0.4 pmol/L of initial value at
▪ The reaction mixture is aspirated into the measuring cell where the concentrations < 2 pmol/L; recovery within ± 10 % of initial value at
microparticles are magnetically captured onto the surface of the concentrations ≥ 2 pmol/L and slope 0.9‑1.1 + intercept within ≤ ± 2x Limit
electrode. Unbound substances are then removed with of Blank + coefficient of correlation ≥ 0.95.
ProCell/ProCell M. Application of a voltage to the electrode then induces Stable for 7 days at 2‑8 °C, 30 days at -20 °C.6 Freeze only once.
chemiluminescent emission which is measured by a photomultiplier.
The sample types listed were tested with a selection of sample collection
▪ Results are determined via a calibration curve which is instrument- tubes that were commercially available at the time of testing, i.e. not all
specifically generated by 2‑point calibration and a master curve provided available tubes of all manufacturers were tested. Sample collection systems
via the reagent barcode or e‑barcode. from various manufacturers may contain differing materials which could
Reagents - working solutions affect the test results in some cases. When processing samples in primary
The reagent rackpack is labeled as FT3 III. tubes (sample collection systems), follow the instructions of the tube
manufacturer.
M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Centrifuge samples containing precipitates before performing the assay.
Streptavidin-coated microparticles 0.72 mg/mL; preservative. Do not use heat‑inactivated samples.
Do not use samples and controls stabilized with azide.
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Ensure the samples, calibrators and controls are at 20‑25 °C prior to Calibration frequency: Calibration must be performed once per reagent lot
measurement. using fresh reagent (i.e. not more than 24 hours since the reagent kit was
Due to possible evaporation effects, samples, calibrators and controls on registered on the analyzer). Renewed calibration is recommended as
the analyzers should be analyzed/measured within 2 hours. 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
▪ 06437222190, 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.
In addition, other suitable control material can be used.
▪ General laboratory equipment
Controls for the various concentration ranges should be run individually at
▪ MODULAR ANALYTICS E170 or cobas e analyzer least once every 24 hours when the test is in use, once per reagent kit, and
Accessories for cobas e 411 analyzer: following each calibration.
▪ 11662988122, ProCell, 6 x 380 mL system buffer The control intervals and limits should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the defined
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning limits. Each laboratory should establish corrective measures to be taken if
solution 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
sample (either in pmol/L, pg/mL or ng/dL).
Accessories for MODULAR ANALYTICS E170, cobas e 601 and
cobas e 602 analyzers: Conversion factors: pmol/L x 0.651 = pg/mL
▪ 04880340190, ProCell M, 2 x 2 L system buffer pg/mL x 1.536 = pmol/L
▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning pg/mL x 0.1 = ng/dL
solution
Limitations - interference
▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and The assay is unaffected by icterus (bilirubin < 1128 µmol/L or < 66 mg/dL),
CleanCell M before use hemolysis (Hb < 0.621 mmol/L or < 1.0 g/dL), lipemia (Intralipid
▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run < 2000 mg/dL), biotin (< 286 nmol/L or < 70 ng/mL), IgG < 7 g/dL, IgA
finalization and rinsing during reagent change < 1.6 g/dL and IgM < 1 g/dL.
▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution Criterion: Recovery within ± 10 % of initial value.
▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction Samples should not be taken from patients receiving therapy with high
cups or pipette tips, waste bags biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin
administration.
▪ 03023150001, WasteLiner, waste bags
No interference was observed from rheumatoid factors up to a
▪ 03027651001, SysClean Adapter M concentration of 1200 IU/mL.
Accessories for all analyzers: Any influence that might affect the binding behavior of the binding proteins
▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean, can alter the result of the fT3 tests (e.g. drugs, NTIs (Non‑Thyroid‑Illness) or
5 x 100 mL system cleaning solution patients suffering from FDH (Familial Dysalbuminemic
Hyperthyroxinemia)).9,10
Assay
In vitro tests were performed on 17 commonly used pharmaceuticals. No
For optimum performance of the assay follow the directions given in this interference with the assay was found.
document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions. The following special thyroid drugs were tested with concentrations shown
in the table below. No interference with the assay was found.
Resuspension of the microparticles takes place automatically prior to use.
Read in the test‑specific parameters via the reagent barcode. If in Criterion: Recovery within ± 10 % of initial value.
exceptional cases the barcode cannot be read, enter the 15‑digit sequence
of numbers (except for the cobas e 602 analyzer). Drug Concentration (µg/mL)
MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Iodid 0.200
PreClean M solution is necessary. Carbimazol 30
Bring the cooled reagents to approximately 20 °C and place on the reagent Thiamazol 80
disk (20 °C) of the analyzer. Avoid foam formation. The system
automatically regulates the temperature of the reagents and the Propylthiouracil 60
opening/closing of the bottles.
Perchlorat 2000
Calibration
Propranolol 240
Traceability: This method has been standardized against the Elecsys FT3
assay ( 03051986190). The Elecsys FT3 assay ( 03051986190) is Amiodaron 200
traceable to the Elecsys FT3 assay ( 11731386122) which was Prednisolon 100
standardized using equilibrium dialysis.5,8
Every Elecsys reagent set has a barcoded label containing specific Hydrocortison 200
information for calibration of the particular reagent lot. The predefined Fluocortolon 100
master curve is adapted to the analyzer using the relevant CalSet.
Octreotid 0.300
Calibration interval may be extended based on acceptable verification of
calibration by the laboratory.

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In in vitro studies the drugs Furosemide and Levothyroxine caused elevated cobas e 411 analyzer
fT3 findings at the daily therapeutic dosage level.
Repeatability Intermediate
In rare cases, interference due to extremely high titers of antibodies to precision
analyte‑specific antibodies, streptavidin or ruthenium can occur. These
effects are minimized by suitable test design. Sample Mean SD CV SD CV
For diagnostic purposes, the results should always be assessed in pmol/L pmol/L % pmol/L %
conjunction with the patient’s medical history, clinical examination and other HSb) 1 1.53 0.045 3.0 0.125 8.2
findings.
HS 2 3.64 0.083 2.3 0.133 3.6
Limits and ranges
Measuring range HS 3 6.43 0.129 2.0 0.199 3.1
0.4‑50 pmol/L (defined by the Limit of Blank and the maximum of the HS 4 27.5 0.657 2.4 0.959 3.5
master curve). Values below the Limit of Blank are reported as HS 5 46.8 0.495 1.1 0.884 1.9
< 0.4 pmol/L. Values above the measuring range are reported as
> 50 pmol/L. PC Uc)1 5.92 0.077 1.3 0.150 2.5
Lower limits of measurement PC U2 24.1 0.492 2.0 0.713 3.0
Limit of Blank, Limit of Detection and Limit of Quantitation
b) HS = human serum
Limit of Blank = 0.4 pmol/L c) PC U = PreciControl Universal
Limit of Detection = 0.6 pmol/L
Limit of Quantitation = 1.5 pmol/L MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers
The Limit of Blank, Limit of Detection and Limit of Quantitation were Repeatability Intermediate
determined in accordance with the CLSI (Clinical and Laboratory Standards precision
Institute) EP17‑A requirements. Sample Mean SD CV SD CV
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of pmol/L pmol/L % pmol/L %
analyte‑free samples over several independent series. The Limit of Blank
corresponds to the concentration below which analyte‑free samples are HS 1 1.33 0.086 6.5 0.096 7.2
found with a probability of 95 %. HS 2 3.49 0.107 3.1 0.113 3.2
The Limit of Detection is determined based on the Limit of Blank and the
standard deviation of low concentration samples. The Limit of Detection HS 3 6.24 0.121 1.9 0.134 2.1
corresponds to the lowest analyte concentration which can be detected HS 4 27.3 0.367 1.3 0.442 1.6
(value above the Limit of Blank with a probability of 95 %).
HS 5 46.0 0.640 1.4 0.855 1.9
The Limit of Quantitation is defined as the lowest amount of analyte in a
sample that can be accurately quantitated with a total allowable error of PC U1 5.67 0.121 2.1 0.131 2.3
≤ 30 %.
PC U2 23.4 0.349 1.5 0.455 1.9
Dilution
Samples for fT3 determinations cannot be diluted, as T3 in the blood is Method comparison
present in free and protein-bound forms which are in equilibrium. A change A comparison of the Elecsys FT3 III assay (y) with the Elecsys FT3
in the concentration of the binding proteins alters this equilibrium. assay (x) using clinical samples gave the following correlations:
Expected values Number of samples measured: 155
Euthyroid: 3.1‑6.8 pmol/L (2.0‑4.4 pg/mL) Passing/Bablok11 Linear regression
These values correspond to the 2.5th and 97.5th percentiles of results
obtained from a total of 5366 healthy test subjects examined. y = 1.05x - 0.233 y = 1.04x - 0.107
For detailed information about reference intervals in children, adolescents τ = 0.943 r = 0.998
and pregnant women, refer to the brochure “Reference Intervals for The sample concentrations were between approximately 0.777 and
Children and Adults”, English: 04640292, German: 04625889. 47.8 pmol/L.
This booklet also contains results of a detailed study about influencing
factors on thyroid parameters in a well characterized reference group of Analytical specificity
adults. Different inclusion and exclusion criteria were applied (e.g. The following cross-reactivities were found, tested with fT3 concentrations
sonographic results (thyroid volume and density) as well as criteria of approximately 4.61 pmol/L (3.00 pg/mL) and 11.4 pmol/L (7.44 pg/mL):
according to the guidelines of the National Academy of Clinical
Biochemistry - NACB). Cross-reactant Concentration tested Cross-reactivity
Each laboratory should investigate the transferability of the expected values pg/mL %
to its own patient population and if necessary determine its own reference L‑T4 300000 0.009
ranges.
D‑T4 625000 0.005
Specific performance data
rT3 10000000 0.0003
Representative performance data on the analyzers are given below.
Results obtained in individual laboratories may differ. 3‑iodo‑L‑tyrosine 100000000 0.000
Precision 3,5‑diiodo‑L‑tyrosine 100000000 0.000
Precision was determined using Elecsys reagents, samples and controls in 3,3’,5‑triiodothyroacetic acid 6250 0.298
a protocol (EP5‑A2) of the CLSI (Clinical and Laboratory Standards
Institute): 2 runs per day in duplicate each for 21 days (n = 84). The 3,3’,5,5’‑tetraiodothyroacetic 1000000 0.0001
following results were obtained: acid
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.

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2 Robbins J, Rall JE. The interaction of thyroid hormones and protein in
biological fluids. Recent Prog Horm Res 1957;13:161-208.
3 Oppenheimer JH. Role of plasma proteins in the binding, distribution
and metabolism of the thyroid hormones. N Engl J Med
1968;278(21):1153-1162.
4 DeGroot LJ, Larsen PR, Hennemann G. Transport of thyroid hormone
and cell uptake. The thyroid and its diseases. Wiley and Sons, New
York, 1984:62-65.
5 Ekins RP. Measurement of free hormones in blood. Endocr Rev
1990;11(1):5-46.
6 Wu AHB. Tietz Clinical Guide To Laboratory Tests. Saunders Elsevier,
Philadelphia, 4th edition, 2006, section II, p. 1076-1077.
7 Brent GA. Thyroid Function Testing. Springer, Berlin, 1st edition, 2010,
chapter 5, p. 86-88.
8 Ekins RP, Ellis SM. The radioimmunoassay of free thyroid hormones in
serum. In Robbins J, Braverman LE (eds). Thyroid research,
Proceedings of the Seventh International Thyroid Conference, Boston.
Amsterdam, Excerpta Medica 1975:597.
9 Wada N, Chiba H, Shimizu C, et al. A novel missense mutation in
codon 218 of the albumin gene in a distinct phenotype of familial
dysalbuminemic hyperthyroxinemia in a Japanese kindred. J Clin
Endocrinol Metab 1997;82(10):3246-3250.
10 Arevalo G. Prevalence of familial dysalbuminemic hyperthyroxinemia in
serum samples received for thyroid testing. Clin Chem
1991;37(8):1430-1431.
11 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, the product
information 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.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see
https://usdiagnostics.roche.com for definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

COBAS, COBAS E, 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.
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