Document No. : INS-TN-EN (Rev.

14)
Revision date : July 20, 2016

The cartridge should remain sealed in its original pouch before use.
Do not use the cartridge, if is damaged or already opened.
Frozen sample should be thawed only once. For shipping, samples
must be packed in accordance with the regulations. Sample with
severe hemolytic and hyperlipidemia cannot be used and should

Tn-I be recollected.
Just before use, allow the cartridge, detection buffer and sample
to be at room temperature for approximately 30 minutes.
ichroma™ Tn-I as well as the instrument for ichroma™ tests should
be used away from vibration and/or magnetic field. During normal
INTENDED USE usage, it can be noted that instrument for ichroma™ tests may
produce minor vibration.
ichroma™ Tn-I is a Fluorescence Immunoassay (FIA) for the Used sample mixing tubes, pipette tips and cartridges should be
quantitative determination of cardiac troponin-I (Tn-I) in human handled carefully and discarded by an appropriate method in
serum/plasma. It is useful as an aid in management and monitoring of accordance with relevant local regulations.
acute myocardial infarction (AMI). An exposure to larger quantities of sodium azide may cause
For in vitro diagnostic use only. certain health issues like convulsions, low blood pressure and
heart rate, loss of consciousness, lung injury and respiratory
INTRODUCTION failure.7
ichroma™ Tn-I will provide accurate and reliable results subject to
Cardiac troponins are currently the most sensitive and specific
the following conditions.
biochemical markers of myocardial necrosis. There are three types of
troponin in heart muscle fibers. Those are troponin-C, troponin-I, and - Use ichroma™ Tn-I should be used only in conjunction with
troponin-T. Together they contribute to make cardiac muscle fibers instrument for ichroma™ tests.
contract. The clinical measurement of serum Tn-I has become an - Any anticoagulants other than heparin, sodium citrate should be
important tool in the diagnosis of acute myocardial infarction. Serum avoided.
Tn-I is a more reliable than creatine kinase as a prognostic marker in
people with ischemic chest pain. National and international scientific STORAGE AND STABILITY
organizations have suggested the use of troponins, Tn-I and Tn-T, when
The cartridge is stable for 20 months (while sealed in an aluminum
implementing new diagnostic strategies in patients with acute
foil pouch) if stored at 4-30 °C.
coronary syndrome.
The detection buffer dispensed in a vial is stable for 20 months if
stored at 2-8 °C.
PRINCIPLE After the cartridge pouch is opened, the test should be performed
The test uses a sandwich immunodetection method; the detector immediately.
antibody in buffer binds to antigen in sample, forming antigen-
antibody complexes, and migrates onto nitrocellulose matrix to be LIMITATION OF THE TEST SYSTEM
captured by the other immobilized-antibody on test strip. The test may yield false positive result(s) due to the cross-
The more antigen in sample forms the more antigen-antibody reactions and/or non-specific adhesion of certain sample
complex and leads to stronger intensity of fluorescence signal on components to the capture/detector antibodies.
detector antibody, which is processed by instrument for ichroma™ The test may yield false negative result. The non-responsiveness
tests to show Tn-I concentration in sample. of the antigen to the antibodies is most common where the
epitope is masked by some unknown components, so as not to be
COMPONENTS detected or captured by the antibodies. The instability or
ichroma™ Tn-I consists of ‘Cartridges’, ‘Detection Buffer Vial’, degradation of the antigen with time and/or temperature may
‘Sample Mixing Tubes’ and an ‘ID chip’. cause the false negative as it makes antigen unrecognizable by the
The cartridge contains a test strip, the membrane which has anti antibodies.
human Tn-I at the test line, while streptavidin at the control line. Other factors may interfere with the test and cause erroneous
Each cartridge is individually sealed in an aluminum foil pouch results, such as technical/procedural errors, degradation of the
containing a desiccant. 25 sealed cartridges are packed in a box test components/reagents or presence of interfering substances
which also contains an ID chip. in the test samples.
The detection buffer contains anti human Tn-I-fluorescence Any clinical diagnosis based on the test result must be supported
conjugate, biotin-BSA-fluorescence conjugate, bovine serum by a comprehensive judgment of the concerned physician
albumin (BSA) as a stabilizer and sodium azide as a preservative in including clinical symptoms and other relevant test results.
phosphate buffered saline.
The detection buffer is dispensed in a vial. Detection buffer vial is MATERIALS SUPPLIED
packaged in a Styrofoam box with ice-pack for the shipment. REF 13011
WARNINGS AND PRECAUTIONS Components of ichroma™ Tn-I
For in vitro diagnostic use only. Cartridge Box:
Carefully follow the instructions and procedures described in this - Cartridges 25
‘Instruction for use’. - ID Chip 1
Use only fresh samples and avoid direct sunlight.
- Instruction For Use 1
Lot numbers of all the test components (cartridge, ID chip and
detection buffer) must match each other. - Sample Mixing Tubes 25
Do not interchange the test components between different lots or Detection Buffer Vial 1
use the test components after the expiration date, either of which
might yield misleading of test result(s).
Do not reuse. A sample mixing tube should be used for processing
one sample only. So should a cartridge.

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Document No. : INS-TN-EN (Rev. 14)
Revision date : July 20, 2016

MATERIALS REQUIRED BUT SUPPLIED ON DEMAND INTERPRETATION OF TEST RESULT

Following items can be purchased separately from ichroma™ Tn-I. Result
Please contact our sales division for more information. - Alternate Result Unit: The default result unit for ichroma™ Tn-I is
Instrument for ichroma™ tests ng/mL. When selecting the alternate result unit, μg/L, the
- ichroma™ Reader REF FR203 conversion factor used by the ichroma system is 1.0. The
- ichroma™ II REF FPRR021 conversion formula to change to the alternate result unit is:
ng/mL x 1.0 = μg/L
- ichroma™ D REF 13303
ichroma™ Printer REF FPRR007 Limits and Ranges
Boditech Cardiac Control REF CFPO-98 - Working range: 0.10–50 ng/mL

SAMPLE COLLECTION AND PROCESSING - Lower limits of measurement:

Limit of Blank (LoB): 0.07 ng/mL
The sample type for ichroma™ Tn-I is human serum/plasma. Limit of Detection (LoD): 0.11 ng/mL
It is recommended to test the sample within 24 hours after Limit of Quantitation (LoQ): 0.30 ng/mL
collection.
- The LoB and LoD were determined in accordance with the CLSI
The serum or plasma should be separated from the clot by
(Clinical and Laboratory Standards Institute) EP17-A2
centrifugation within 3 hours after the collection of whole blood.
requirements.
If longer storage is required, e.g. if the test could not be performed
- The LOB is the 95th percentile value from n ≥ 60 measurements
within 24 hours, serum or plasma should be immediately frozen
of analyte-free samples over several independent series.
below -20 °C. The freezing storage of sample up to 3 months does
not affect the quality of results. - The LoD is determined based on the LoB and the standard
Once the sample was frozen, it should be used one time only for deviation of low concentration samples.
test, because repeated freezing and thawing can result in the - The LoQ (functional sensitivity) is the lowest analyte
change of test values. concentration that can be reproducibly measured with an
intermediate precision CV of ≤ 20 %.
TEST SETUP Expected Values
Check the contents of ichroma™ Tn-I: Sealed Cartridge, Detection - In studies performed with the ichroma™ Tn-I assay involving 100
Buffer Vial, Sample Mixing Tubes and ID Chip. healthy volunteers in Korea, the upper reference limit (99th
Ensure that the lot number of the cartridge matches that of the ID percentile) for Tn-I was 0.11 ng/mL. The lowest concentration
chip as well as the detection buffer. with a CV less than or equal to 10 % with the ichroma™ Tn-I assay
Keep the sealed cartridge (if stored in refrigerator) and the was 0.50 ng/mL.
detection buffer tube at room temperature for at least 30 minutes - Due to the release kinetics of Tn-I, a result below the decision
just prior to the test. Place the cartridge on a clean, dust-free and limit within the first hours of the onset of symptoms does not
flat surface. rule out myocardial infarction with certainty. If myocardial
Turn on the instrument for ichroma™ tests. infarction is still suspected, repeat the test at appropriate
Insert the ID Chip into the ID chip port of the instrument for intervals.
ichroma™ tests.
Press the ‘Select’ button on the instrument for ichroma™ tests. - A cut-off of 0.3 ng/mL Tn-I is recommended for diagnosis of AMI,
(Please refer to the ‘Instrument for ichroma™ tests Operation as this yields optimal performance of 91 % of sensitivity and 92.1 %
Manual’ for complete information and operating instructions.) of specificity. However, laboratories should establish their own
diagnostic cut-off concentration based on the clinical practice at
TEST PROCEDURE their perspective institutions.

1) Transfer 75 µL (Human serum/plasma/control) to an empty QUALITY CONTROL

sample mixing tube using a transfer pipette and add 75 µL
Quality control tests are a part of the good testing practice to
detection buffer to it.
confirm the expected results and validity of the assay and should
2) Close the lid of the sample mixing tube and mix the sample
be performed at regular intervals.
thoroughly by shaking it about 10 times. (The sample mixture
The control tests should be performed immediately after opening
must be used immediately.)
a new test lot to ensure the test performance is not altered.
3) Pipette out 75 µL of a sample mixture and load it into the
Quality control tests should also be performed whenever there is
sample well on the cartridge.
any question concerning the validity of the test results.
4) Leave the sample-loaded cartridge at room temperature for 12
Control materials are not provided with ichroma™ Tn-I. For more
minutes.
information regarding obtaining the control materials, contact
Scan the sample-loaded cartridge immediately when the
incubation time is over. If not, it will cause inexact test result. Boditech Med Inc.’s Sales Division for assistance.
5) To scan the sample-loaded cartridge, insert it into the cartridge (Please refer to the instruction for use of control material.)
holder of the instrument for ichroma™ tests. Ensure proper
PERFORMANCE CHARACTERISTICS
orientation of the cartridge before pushing it all the way inside
the cartridge holder. An arrow has been marked on the Specificity: There, in test samples, are biomolecules such as as
cartridge especially for this purpose. heparin, protein kinase A (PKA), creatine kinase, autoantibodies,
6) Press ‘Select’ button on the instrument for ichroma™ tests to and free and binary or ternary troponin complex were added to
start the scanning process. the test sample(s) at concentrations much higher than their
7) Instrument for ichroma™ tests will start scanning the sample- normal physiological levels in blood. ichroma™ Tn-I test results did
loaded cartridge immediately. not show any significant cross-reactivity with these biomolecules.
8) Read the test result on the display screen of the instrument for Precision: The intra-assay precision was calculated by one
ichroma™ tests. evaluator, who tested different concentration of control standard
ten times each with three different lots of ichroma™ Tn-I. The
inter-assay precision was confirmed by 3 different evaluators with
양식-GE02-15 (Rev .03) 2/3
Document No. : INS-TN-EN (Rev. 14)
Revision date : July 20, 2016

3 different lots, testing three times each different concentrations. Heart, Lung and Circulation 2007;16;S13-S16.
Intra-assay 3. David M. Bunk and Micahel J. Welch. Characterization of a New
Tn-I (ng/mL) Certified Reference Material for Human Cardiac Troponin I.
Mean SD CV (%) Clinical Chemistry 2002;52:2:212-219
0.20 0.18 0.03 22.77 4. Jaffe AS, Ravkilde J, Roberts R, Naslund U, Apple FS, Galvani M,
Katus H. It’s time for a change to a troponin standard. Circulation
0.40 0.39 0.02 8.31 2000;102:1216 –1220.
2.70 2.65 0.07 4.96 5. Jillan R. Tate, David Heathcote, Gus Koerbin, Gary Thean, David
Andriske, Jone Bonar, Janice Gill. Theharmonization of cardiac
9.00 9.02 0.19 2.79 troponin I measurement is independent of sample time
collection but is dependent on the source of calibrator. Clinica
26.00 25.99 0.76 2.14
Chimica Acta 324:2002:13-23.
6. Ohman EM, Armstrong PW, Christenson RH, et al. Cardiac
Inter-assay troponin T levels for risk stratification in acute myocardial
Tn-I (ng/mL)
ischemia. N Engl J Med 1996;335:1333– 41.
Mean SD CV (%)
7. Antman EM, Tanasijevic MJ, Thompson B, et al. Cardiacspecific
0.20 0.20 0.04 38.40 troponin I levels to predict the risk of mortality in patients with
acute coronary syndromes. N Engl J Med 1996;335:1342 –9.
0.40 0.38 0.03 18.27
Note: Please refer to the table below to identify various symbols
2.70 2.58 0.13 5.53

9.00 9.02 0.27 3.00

26.00 26.00 0.68 2.6

Diagnostic sensitivity and specificity

A total of 122 serum/plasma samples, 46 positive and 76
negative, were tested a commercially available troponin I assay.
The sample were tested by ichroma™ instrument. The sample
concentrations were between approx. 0.10 and 18.44 ng/mL.
A Receiver Operating Characteristic (ROC) curve was calculated
from the peak troponin values.
Calculation of the peak values of the commercially available
cardiac troponin I test measured in parallel yielded the following
results for the officially stated ROC optimized cut-off of 0.30 -
0.50 ng/mL.
Cut-off
Sensitivity 95% CI Specificity 95% CI
μg/L N N
(%) (%) (%) (%)
(ng/mL)
42/ 70/
0.30 91.3 79.2~97.6 92.11 83.6~97.0
46 76
36/ 72/
0.50 78.26 63.6~89.1 94.74 85.3~97.8
46 76

Comparability: Tn-I concentrations of 150 clinical samples were

quantified independently with ichroma™ Tn-I and mini VIDAS
(BioMerieux Inc. France) as per prescribed test procedures. Test For technical assistance; please contact:
results were compared and their comparability was investigated Boditech Med Inc.’s Technical Services
with linear regression and coefficient of correlation (R). Linear Tel: +82 33 243-1400
regression and coefficient of correlation between the two tests E-mail: [email protected]
were Y= 1.645 X – 0.1831 and R = 0.9890 respectively.

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
REFERENCES E-Mail: [email protected]
1. Mauro Panteghini, Franca Pacani, Kiang-Teck J.Yeo, Fred S. Apple,
Robert H. Christenson. Francesco Dati, Johannes Mair, Jan
Ravkilde, and Alan H.B. We. Evaluation of Imprecision for Cardiac
Troponin Assays at Low-Range Concentrations. 2004;50:2:327-
332.
2. Alan McNeil, PhD, FRACP, FRCPA. The Trouble with Troponin.

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