Cardiac Troponin I Test Cassette
REF FI-CTI-402
English
Concentrations
Clinical Reference
0.5 ng/mL
Not indicative of Acute Myocardial Infarction
0.5 ng/mL
Indicative of Acute Myocardial Infarction
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Hangzhou AllTest Biotech Co., Ltd.
MedNet EC-REP GmbH
Borkstrasse 10
48163 Muenster
Germany
(Whole Blood /Serum/Plasma)
Package Insert
A test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I (cTnI) in whole blood,
serum or plasma with the use of Fluorescence Immunoassay Analyzer.
For professional in vitro diagnostic use only.
INTENDED USE】
【
The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is intended for in vit ro quantitative
determination of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis
of Myocardial Infarction (MI).
SUMMARY】
【
Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5
[1]
.Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with
kDa
tropomyosin, this structural complex forms the main component that regulates the calcium sensitive
ATPase activity of actomyosin in striated skeletal and cardiac muscle
Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI is
similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated
for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of
cTnI measurements for the identification of myocardial damage has been demonstrated in conditions
such as the perioperative period, after marathon runs, and blunt chest trauma
been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable
angina, congestive heart failure, and ischemic damage due to coronary artery bypass
4
.Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently
surgery
become the most preferred biomarker for myocardial infarction
The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a
combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in whole blood,
serum or plasma.
【
PRINCIPLE】
The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) detects cardiac Troponin I (cTnI)
based on Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad. If the specimen contains cTnI, it attaches to the fluorescent microspheres-conjugated
anti-cTnI antibodies. Then the complex will be captured by the capture antibodies coated on the
nitrocellulose membrane (Test line).The concentration of cTnI in the sample correlates with the
fluorescence signal intensity captured on the T line. According to the fluorescence intensity of the test
and product standard curve, the concentration of cTnI in the sample can be calculated by analyzer to
show cTnI concentration in specimen.
REAGENTS】
【
The test kit includes anti-cTnI antibody coated fluorophores and anti-cTnI antibody coated on the
membrane.
PRECAUTIONS】
【
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is
damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection container for each
specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle all
specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for proper disposal
of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection
when specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The cTnI Test Cassette should only be used with the Analyzer by approved medical professionals.
STORAGE AND STABILITY】
【
1. The test should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND PREPARATION】
【
Preparation
1. Before performing the test, please make sure that all components are brought to room
temperature(15-30 ℃). Cold buffer solution or moisture condensation on the membrane can lead to
invalid test results.
2. Take a tube with buffer solution out of the kit. Document patients name or ID on it.
Sample Handling
1. Collect the specimen according to standard procedures.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to
dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the
fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the
puncture site.
2. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens
may be stored at 2-8 °C for up to 1 day, for long term storage, specimens should be kept below
-20 °C. Whole blood collected by venipuncture should be stored at 2-8 °C if the test is to be used
within 1 day of collection. Do not freeze whole blood specimens. Whole blood collected by finger stick
should be tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed
2
.After cardiac injury occurs,
5
.
3
.cTnI release has also
and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
4. EDTA K2, Heparin sodium, Citrate sodium and Oxalate potassium can be used as the anticoagulant
tube for collecting the blood specimen.
Sample Dilution
1. The specimen (75 μL of serum/plasma/whole blood) can be added directly with the micro pipette
into the buffer.
2. Close the tube and shake the sample by hand for approximately 10 seconds so sample and dilution
buffer mix well.
3. Let the diluted sample homogenize for approximately 1 minute.
4. It is best to place the diluted sample on an ice pack and leave the sample at room temperature for no
more than 2 hours.
MATE RIALS】
【
• Test Cassettes • Specimen Collection Tubes with Buffer
• ID Card • Package Insert
• Droppers • Lancets
• Timer • Centrifuge • Fluorescence Immunoassay Analyzer • Pipette
DIRECTIONS FOR USE】
【
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use
of the Test. The test should be conducted at room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick test”
mode.
2. Take out the ID card and insert it into the Analyzer port.
3. To use a pipette: Pipette 75μL of sample into the buffer tube; mix the specimen and the buffer
well.
To use a dropper: Immerse the tube end into the sample; squeeze the top bulb to absorb the
sample into the lower bulb (no more than the lower bulb). Then release the sample into the buffer
tube by squeezing the bulb at the top end of the dropper vertically. Wash the tube 2-3 times by
squeezing the top bulb. Mix the sample and the buffer well.
4. To use a pipette: Pipette 75 μL of diluted specimen into the sample well of the cassette. Start the
timer at the same time.
To use a dropper: Immerse the tube end into the diluted sample; squeeze the top bulb to absorb
the solution into the lower bulb (no more than the lower bulb). Squeeze the top bulb vertically to
release the diluted solution into the sample well of the test cassette and start the timer.
5. There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test mode and Quick
Test mode. Please refer to the user manual of Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after sample application
and click "New test ", the Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after sample application,
click "New test" at the same time, the Analyzer will automatically count down 15 minutes. After the
countdown, the Analyzer will give the result at once.
INTERPRETATION OF RESULTS】
【
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for cTnI is calculated by Fluorescence Immunoassay Analyzer and display the result
on the screen. For additional information, please refer to the user manual of Fluorescence
Immunoassay Analyzer.
Linearity range of cTnI Test is 0.1-40 ng/mL.
QUALITY CONTROL】
【
Each cTnI Test Cassette contains internal control that satisfies routine quality control requirements.
This internal control is performed each time a sample is tested. This control indicates that the test
cassette was inserted and read properly by Fluorescence Immunoassay Analyzer. An invalid result
from the internal control causes an error message on Fluorescence Immunoassay Analyzer indicating
that the test should be repeated. An invalid result from the internal control causes an “N/A” message on
Fluorescence Immunoassay Analyzer. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control failure. Review the procedure and repeat the test with a new test.
If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Materials Provided
Materials Required But Not Provided
LIMITATIONS】
【
1. The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is for professional in vitro
diagnostic use, and should only be used for the quantitative detection of Cardiac Troponin I.
2. The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence
of Cardiac Troponin I antigen in the specimen and should not be used as the sole criteria for
evaluating Myocardial Infarction.
3. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all
clinical and laboratory findings have been evaluated.
4. High concentrations of Cardiac Troponin I may produce a dose hook effect, resulting in incorrect
interpretation of Cardiac Troponin I levels. High dose hook effect has not been observed with this test
up to 40ng/mL of Cardiac Troponin I.
5. The hematocrit of the whole blood should be between 25% and 65%.
6. The results of cTnI Tests are based on measuring the levels of cTnI in a specimen. It should no t be
used as the sole criterion for treatment decisions. If the result is positive, other clinical findings and
alternative test methods are recommended to reach proper medical treatments.
EXPECTED VALUES】
【
＜
＞
【PERFORMANCE CHARACTERISTICS】
1. Accuracy
The test deviation is ≤±15%.
2. Sensitivity
The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) can detect levels of Cardiac
Troponin I as low as 0.1ng/mL whole blood, serum or plasma.
3. Detection range
0.1~40 ng/mL
4. Linearity range
0.1~40 ng/mL , R≥0.990
5. Precision
CV≤15%
6. Cross-reactivity
Cross-reactivity studies were carried out with following analytes .
10,000 ng/mL Skeletal Troponin I, 2,000 ng/mL Troponin T, 20,000 ng/mL Cardiac Myosin, HBsAg,
HBsAb, HBeAg, HBeAb, HBcAb, syphilis, anti -HIV, anti-H.pylori, MONO, anti-CMV, anti-Rubella and
anti-Toxoplasmosis positive specimens. The results showed no cross-reactivity.
7. Interfering Substances
The following potentially interfering substances were added to cTnI negative and positive specimens.
Acetaminophen: 20 mg/dl Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
Ascorbic Acid: 20mg/mL Albumin: 10,500mg/dL
Creatin: 200 mg/dL Hemoglobin 1,000 mg/dL
Bilirubin: 1,000mg/dL Oxalic Acid: 600mg/dL
Cholesterol: 800mg/dL Triglycerides: 1,600mg/dL
None of the substances at the concenntration tested interfered in the assay.
LITERATURE REFERENCES】
【
1. Adams,et al. Biochemical markers of myocardial injury, Immunoassay Circulation 88:750-763,1993.
2. Mehegan JP,Tobacman LS.Cooperative interaction between troponin molecules bound to the
cardiac thin filament. J.Biol.Chem. 266:966, 1991.
3. Adams, et al. Diagnosis of Perioperative myocardial infarction with measurements of cardiac troponin
I. N.Eng.J.Med 330:670, 1994.
4. Hossein-Nia M, et al. Cardiac troponin I release in heart transplantation.Ann.Thorac. Surg. 61:227,
1996.
5. Alpert JS, et al. Myocardial Infarction Redefined, Joint European Society of Cardiology American
College of Cardiology: J. Am. Coll.Cardio.,36(3):959,2000.
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Number: F145107600
Revision date: 2022-09-23
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