Document No.

: INS-DT3-EN
Revision date : May 07, 2021 (Rev. 04)

immobilized and interferes with the binding of analyte and

fluorescence labeled (FL) antibody. If more analytes exist in
the sample, less detection antibodies are accumulated,
resulting in less fluorescence signal.

T3
COMPONENTS
ichroma™ T3 consists of ‘cartridges’, ‘detector tubes’,
‘detector diluents’.
 The cartridge contains the membrane called a test strip

INTENDED USE which has T3-BSA at the test line, and chicken IgY at the
control line. All cartridges are individually sealed in an
ichroma™ T3 is a fluorescence Immunoassay (FIA) for the
aluminum foil pouch containing a desiccant in a box.
quantitative determination of triiodothyronine (total T3) in
 The detector tube has a granule containing anti human T3-
human serum/plasma. It is useful as an aid in management
fluorescence conjugate, anti chicken IgY-fluorescence
and monitoring of determination of thyroid disorders.
conjugate, bovine serum albumin (BSA) and sucrose as a
For in vitro diagnostic use only.
stabilizer, mouse IgG as a blocker and sodium azide as a
INTRODUCTION preservative in sodium phosphate buffer. All detector
tubes are packed in a box.
3,5,3' Triiodothyronine (T3) is a thyroid hormone with a  The detector diluent contains 8-anilinonaphthalene-1-
molecular weight of 651 daltons.1 sulfonic acid (ANS), Tween20 as detergent, sodium azide
T3 circulates in the blood as an equilibrium mixture of free as a preservative in sodium hydroxide solution, and it is
and protein bound hormone.2 T3 is bound to thyroxin pre-dispensed in 2 vials. The detector diluents are packed
binding globulin (TBG), prealbumin, and albumin. The actual in a box.
distribution of T3 among these binding proteins is
controversial as estimates range from 38-80 % for TBG, 9-27 % WARNINGS AND PRECAUTIONS
for prealbumin, and 11-35 % for albumin.3  For in vitro diagnostic use only.
T3 plays an important role in the maintenance of the  Follow instructions and procedures described in this
euthyroid state. T3 measurements can be a valuable ‘Instruction for use’.
component in diagnosing certain disorders of thyroid  Use only fresh samples and avoid direct sunlight.
function.4 Most reports indicate that T3 levels distinguish  It is possible to use frozen samples. Please refer to
clearly between euthyroid and hyperthyroid subjects, but “SAMPLE COLLECTION AND PROCESSING”.
provide a less clear-cut separation between hypothyroid and  Lot numbers of all the test components (cartridge,
euthyroid subjects.5 Total T3 measurements may be valuable detector tube, detector diluent and ID chip) must match
when hyperthyroidism is suspected and the free T4 is each other.
normal.6 For example, one recognized type of thyroid  Do not interchange the test components between
dysfunction is T3 thyrotoxicosis, associated with a decrease different lots or use the test components after the
in serum thyroid stimulating hormone (TSH), increased T3 expiration date, either of which might yield incorrect test
level, normal T4, normal free T4, and normal to increase in result(s).
vitro Uptake results.7-11  Do not reuse cartridges or detector tubes. A cartridge
T3 levels are affected by conditions which affect TBG should be used for testing one sample only. A detector
concentration.12-14 Slightly elevated T3 levels may occur in tube should be used for processing of one sample only.
pregnancy or during estrogen therapy, while depressed  The cartridge should remain sealed in its original pouch
levels may occur during severe illness, renal failure, until just before use. Do not use the cartridge, if pouch is
myocardial infarction, alcoholism, inadequate nutritional damaged or has already been opened.
intake, and during therapy with some medications such as  Frozen sample should be thawed only once. For shipping,
dopamine, glucocorticoids, methimazone, propranolol, samples must be packed in accordance with local
propylthiouracil, and salicylates.6,15,16 regulations. Sample with severe hemolysis and/or
Numerous conditions unrelated to thyoid disease may hyperlipidemia must not be used.
cause abnormal T3 values.5, 17-20 Consequently, total T3  Allow cartridge, detector tube, detector diluent and
values should not be used on their own in establishing the sample to be at room temperature for approximately 30
thyroid status of an individual. The level of serum T4, TSH minutes before use.
and other clinical findings must be considered as well.  The instrument for ichroma™ tests may generate slight
vibration during use.
PRINCIPLE
 Used cartridges, detector tubes, detector diluents and
The test uses a competitive immunodetection method. pipette tips should be handled carefully and discarded by
In this method, the analyte in the sample binds to the an appropriate method in accordance with relevant local
fluorescence labeled (FL) detection antibody in detection regulations.
buffer, to form the complex as sample mixture. This complex  No Biotin interference was observed in ichroma™ T3 when
is loaded to migrate onto the nitrocellulose matrix, where biotin concentration in the sample was below 1,200
the covalent couple of T3 and bovine serum albumin (BSA) is ng/mL. If a patient has been taking biotin at dosage of
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Document No. : INS-DT3-EN
Revision date : May 07, 2021 (Rev. 04)

more than 0.03 mg a day, it is recommended to test again

24 hours after discontinuation of biotin intake. MATERIALS REQUIRED BUT SUPPLIED ON DEMAND
 An exposure to larger quantities of sodium azide may Following items can be purchased separately from
cause certain health issues like convulsions, low blood ichroma™ T3.
pressure and heart rate, loss of consciousness, lung injury Please contact our sales division for more information.
and respiratory failure.  Instrument for ichroma™ tests

 ichroma™ T3 will provide accurate and reliable results - ichroma™ Reader REF FR203
subject to the below conditions. - ichroma™ II REF FPRR021
- ichroma™ T3 should be used only in conjunction with  Printer REF FPRR007
instrument for ichroma™ tests.
 i-Chamber REF FPRR009
- Have to use recommended anticoagulant sample.
 Boditech Hormone Control REF CFPO-95
Recommended anticoagulant
 Boditech T3 Control REF CFPO-240
Sodium heparin

STORAGE AND STABILITY SAMPLE COLLECTION AND PROCESSING

Storage condition The sample type for ichroma™ T3 is human serum/plasma.
Storage  It is recommended to test the sample within 24 hours after
Component Shelf life Note
Temperature collection.
Cartridge 4 - 30 °C. 20 months Disposable  The serum or plasma should be separated from the clot by
Detector tube 4 - 30 °C. 20 months Disposable centrifugation within 3 hours after the collection of whole
Detector 4 - 30 °C. 20 months Unopened blood.
diluent 4 - 30 °C. 3 months Opened  Samples may be stored for up to a month at 2-8 °C prior to
 After the cartridge pouch is opened, the test should be being tested. If testing will be delayed more than a month,
performed immediately. samples should be frozen at -20 °C.
 Samples stored frozen at -20 °C for 2 months showed no
LIMITATION OF THE TEST SYSTEM
performance difference.
 The test may yield false positive result(s) due to the cross-  Once the sample was frozen, it should be used one time
reactions and/or non-specific adhesion of certain sample only for test, because repeated freezing and thawing can
components to the capture/detector antibodies. result in the change of test values.
 The test may yield false negative result(s) due to the non-
responsiveness of the antigen to the antibodies which is TEST SETUP
the most common if the epitope is masked by some
unknown components, so therefore not being able to be  Check the contents of ichroma™ T3: Sealed Cartridges,
detected or captured by the antibodies. The instability or Detector tubes, Detector diluents, ID chip, and an
degradation of the antigen with time and/or temperature Instruction for use.
may also cause false negative result as it makes antigen  Ensure that the lot number of the cartridge matches that
unrecognizable by the antibodies. of the detector tube, detector diluent as well as ID chip.
 Other factors may interfere with the test and cause  If the sealed cartridge, the detector tube, and the detector
erroneous results, such as technical/procedural errors, diluent have been stored in a refrigerator, place them on a
degradation of the test components/reagents or presence clean and flat surface at room temperature for at least 30
of interfering substances in the test samples. minutes before testing.
 Any clinical diagnosis based on the test result must be  Turn on the instrument for ichroma™ tests.
supported by a comprehensive judgment of the (Please refer to the ‘Instrument for ichroma™ tests
concerned physician including clinical symptoms and Operation Manual’ for complete information and
other relevant test results. operating instructions.

MATERIALS SUPPLIED CAUTION

 To minimize erroneous test results, we suggest that the
REF CFPC-44
ambient temperature of the cartridge should be 25 °C
Components of ichroma™ T3 during the reaction time after loading sample mixture to
 Cartridge Box: the cartridge.
- Cartridge 25  To maintain the ambient temperature to 25 °C, you can use
- Detector tube 25 various devices such as an i-Chamber or an incubator and
- Detector diluent 2 so on.
- ID chip 1
- Instruction for Use 1

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Document No. : INS-DT3-EN
Revision date : May 07, 2021 (Rev. 04)

TEST PROCEDURE QUALITY CONTROL

1) Transfer 300 μL of detector diluent using a pipette to  Quality control tests are a part of the good testing practice
a detector tube containing a granule. When the to confirm the expected results and validity of the assay
granule form is completely dissolved in the tube, it and should be performed at regular intervals.
becomes detection buffer.  The control tests should be performed immediately after
(The detection buffer must be used immediately opening a new test lot to ensure the test performance is
within 3 minutes.) not altered.
2) Transfer 75µL of sample (Human serum/plasma/  Quality control tests should also be performed whenever
control) using a pipette to a detector tube. there is any question concerning the validity of the test
3) Mix well by pipetting 10 times. results.
4) Close the lid of the detector tube and mix the sample  Control materials are provided on demand with ichroma™
thoroughly by shaking it about 10 times. T3. For more information regarding obtaining the control
5) Incubate the detection buffer + sample mixture at materials, contact Boditech Med Inc.’s Sales Division for
room temperature for 8 minutes. assistance.
6) Pipette out 75 µL of a sample mixture and load it into (Please refer to the instruction for use of control material.)
the sample well on the cartridge.
PERFORMANCE CHARACTERISTICS
7) Insert the sample-loaded cartridge into the slot of the
i-Chamber or an incubator (25 °C).  Analytical sensitivity
8) Leave the sample-loaded cartridge in the i-Chamber Limit of Blank (LoB) 0.23 nmol/L
or an incubator for 8 minutes. Limit of Detection (LoD) 0.45 nmol/L
Scan the sample-loaded cartridge immediately Limit of Quantitation (LoQ) 0.77 nmol/L
when the incubation time is over. If not, it will cause
inaccurate test result.  Analytical specificity
9) To scan the sample-loaded cartridge, insert it into the - Cross reactivity
cartridge holder of the instrument for ichroma™ Biomolecules such as below the ones in the table were
tests. Ensure proper orientation of the cartridge added to the test sample(s) at concentrations much
before pushing it all the way inside the cartridge higher than their normal physiological levels in the
holder. An arrow is marked on the cartridge especially blood. ichroma™ T3 test results did not show any
for this purpose. significant cross-reactivity with these biomolecules.
10) Press the ‘Select’ or Tap the ‘START’ button on the
Cross reactants Concentration
instrument for ichroma™ tests to start the scanning
D-thyroxine 300 ng/ml
process.
L-thyroxine 300 ng/ml
11) The instrument for ichroma™ tests will start scanning
Reverse T3 500 ng/ml
the sample-loaded cartridge immediately. Salicylic acid 1,000,000 ng/ml
Monoiodotyrosine 50,000 ng/ml
INTERPRETATION OF TEST RESULT
- Interference
 The Instrument for ichroma™ tests calculates the test Study of interference from table below with ichroma™
result automatically and displays T3 concentration of the T3 showed following results. EDTA (K2), sodium citrate
test sample in terms of ng/mL and nmol/L. and Cholesterol have effects on ichroma™ T3 test in the
 Reference range procedure. So, EDTA (K2) and sodium citrate as an
nmol/L anticoagulant are not recommended on ichroma™ T3
Age group of the subject ng/mL
(SI unit) test.
Adult 0.8–2.0 1.23–3.08 Interference materials Concentration
1-10 years 0.82–2.82 1.26 –4.34 D-glucose 60 mM/L
11-15 Male 0.8–2.33 1.23–3.59 L-Ascorbic acid 0.2 mM/L
Pediatric years Female 0.6–2.09 0.92–3.22 Bilirubin 0.4 mM/L
Ranges
16-17 Male 0.71–2.12 1.09–3.27 Hemoglobin 2 g/L
years Female 0.61–1.51 0.94–2.33 Cholesterol 13 mM/L
triglyceride 10 mg/mL
 Working range : 0.5-5.0 ng/mL (0.77-7.7 nmol/L)
EDTA_K2 10.8 mg/mL
 Conversion factor as unit of nmol/L
Sodium Heparin 54 mg/mL
- nmol/L (SI unit) = 1.54 × ng/mL
Sodium Citrate 40 mg/mL
- ng/dl = 100 × ng/mL

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Document No. : INS-DT3-EN
Revision date : May 07, 2021 (Rev. 04)

 Precision 8
One person tested three standard materials (three lot y = 0.9473x + 0.0436
every 7 days) twice a day (Run, morning/afternoon) and R = 0.9958
6

ichroma™ T3 [nmol/L]
twice repeated (duplicate) in the same place for 21 days.
- Repeatability (within-run precision)
4
To evaluate repeatability, the mean value and CV(%)
were calculated from the results of Run 1 in Lot 1.
2
- Total precision (within-laboratory precision)
To evaluate total precision, the mean value and CV(%)
are calculated from the all results of Lot 1. 0
0 2 4 6 8
Total precision Comparator A [nmol/L]
lot to lot
T3 Repeatability (within-laboratory
precision
[nmol/L] precision) REFERENCES
AVG CV(%) AVG CV(%) AVG CV(%)
1.08 1.09 6.63 1.08 6.9 1.08 6.77 1. O'Neil MJ, editor. The Merck Index. 13th ed.
2.31 2.32 6.26 2.31 6.6 2.32 6.25 Whitehouse Station, NJ: Merck & Co., Inc., 2001;987-
6.16 6.16 6.58 6.17 6.3 6.18 6.22 988.
- Between site 2. Ekins RP. Methods for the measurement of free thyroid
Three persons tested ichroma™ T3 at three different hormones. In: Free Thyroid Hormones: Proceedings of
sites, ten times at each concentration of standard the International Symposium Held in Venice, December
materials. 1978. Amsterdam: Excerpta Medica; 1979:72-92.
- Between person 3. Robbins J, Rall JE. The iodine-containing hormones. In:
Three persons tested ichroma™ T3, ten times at each Gray CH, James VHT, eds. Hormones in Blood. Vol 1. 3rd
concentration of standard materials ed. London: Academic Press, 1979;632-667.
T3 Between site Between person 4. Demers LM, Spencer CA, eds. Laboratory medicine
[nmol/L] AVG CV(%) AVG CV(%) practice guidelines: laboratory support for the diagnosis
1.08 1.08 0.07 1.08 0.06 and monitoring of thyroid disease. Thyroid. 2003;13:3-
2.31 2.32 0.11 2.27 0.14 126.
6.12 6.14 0.39 6.16 0.35
5. Hollander CS, Shenkman L. Radioimmunoassay for
 Accuracy triiodothyronine and thyroxine. In; Rothfeld B, editor.
The accuracy was confirmed by testing with 3 different lots Nuclear medicine in vitro. Philadelphia: Lippincott,
of ichroma™ T3. The tests are repeated 10 times in each 1974;136-49.
different concentration. 6. Kaplan MM, Larsen PR, Crantz FR, Dzau VJ, Rossing TH,
Expected Haddow JE. Prevalence of abnormal thyroid function
value Lot 1 Lot 2 Lot 3 AVG Recovery (%) test results in patients with acute medical illnesses. Am
[nmol/L] J Med. 1982;72:9-16.
6.16 6.05 6.14 6.09 6.09 98.91 7. Larsen PR. Triiodothyronine: Review of Recent Studies
5.14 5.11 5.27 5.33 5.23 101.8 of Its Physiology and Pathophysiology in Man.
4.13 4.14 4.09 4.24 4.15 100.7 Metabolism. 1972;21:1073-1092.
3.11 3.18 3.16 3.05 3.13 100.7 8. Klee GG. Clinical usage recommendations and analytical
2.09 2.08 2.05 2.09 2.07 99.0 performance goals for total and free triiodothyronine
1.08 1.09 1.12 1.04 1.08 100.5 measurements. Clin Chem. 1996;42:155-159.
9. Ivy HK, Wahner HW, Gorman CA. "Triiodothyronine (T3)
 Comparability
toxicosis": its role in Graves' disease. Arch Intern Med.
T3 concentrations of 100 serum samples were quantified
1971;128:529-534.
independently with ichroma™ T3(ichroma™ II) and
10. Hollander CS, Mitsuma T, Nihei N, Shenkman L, Burday
Comparator A as per prescribed test procedures. Test
SZ, Blum M. Clinical and laboratory observations in
results were compared, and their comparability was
cases of triiodothyronine toxicosis confirmed by
investigated with linear regression and coefficient of
radioimmunoassay. Lancet. 1972;1:609-611.
correlation (R). Linear regression and coefficient of
11. Sterling K, Refetoff S, Selenkow HA. T3 thyrotoxicosis:
correlation between the tests were below.
thyrotoxicosis due to elevated serum triiodothyronine
X-axis Y-axis linear regression R
levels. JAMA. 1970;213:571-575.
Comparator A ichroma™ II y = 0.9473x + 0.0436 0.9958 12. Kaplan MM, Larsen PR, Crantz FR, Dzau VJ, Rossing TH,
Haddow JE. Prevalence of abnormal thyroid function
test results in patients with acute medical illnesses. Am
J Med. 1982;72:9-16.
13. Bermudez F, Surks MI, Oppenheimer JH. High incidence
of decreased serum triiodothyronine concentration in
patients with nonthyroid disease. J Clin Endocrinol
Metab. 1975;41:27-40.

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Document No. : INS-DT3-EN
Revision date : May 07, 2021 (Rev. 04)

14. Oppenheimer JH. Thyroid function tests in nonthyroidal Note: Please refer to the table below to identify various
disease. J Chronic Dis. 1982;35:697-701. symbols
15. Abuid J, Larsen PR. Triiodothyronine and thyroxine in
hyperthyrodism: comparison of the acute changes
during therapy with antithyroid agents. J Clin Invest.
1974;54:201-208.
16. Felig P, Frohman LA, eds. Endocrinology & Metabolism.
4th ed. New York: McGraw-Hill, Inc., 2001:270-311.
17. Bates HM. Clin Lab Prod 1974;3:16.
18. Utiger RD. Serum triiodothyronine in man. Annu Rev
Med 1974;2:289-302.
19. Larson PR. Triiodothyronine: review of recent studies of
its physiology and pathophysiology in man. Metabolism
1972;21:1073-92.
20. Oppenheimer JH. Role of plasma proteins in the binding,
distribution and metabolism of the thyroid hormones.
N Engl J Med 1968;278:1153-62.
21. http://cclnprod.cc.nih.gov/dlm/testguide.nsf/Index/8C
30C39D10A6B79E85256BA7004F7E9E

For technical assistance; please contact:

Boditech Med Inc.’s Technical Services
Tel: +(82) -33-243-1400
E-mail: [email protected]

Boditech Med Incorporated

43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gang-won-do, 24398
Republic of Korea
Tel: +(82) -33-243-1400
Fax: +(82) -33-243-9373
www.boditech.co.kr

Obelis s.a
Bd. Général Wahis 53, 1030 Brussels, BELGIUM
Tel: +(32) -2-732-59-54
Fax: +(32) -2-732-60-03
E-Mail: [email protected]

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