The Troponin I/Myoglobin/CK-MB (3 in 1) Test Cassette (Whole
Blood/Serum/Plasma) is intended for in vitro quantitative determination of human cardiac
Troponin I, Myoglobin and CK-MB in whole blood, serum or plasma as an aid in the
diagnosis of Myocardial Infarction (MI).
【SUMMARY】
Myoglobin (MYO), Creatine Kinase MB (CK-MB) and cardiac Troponin I (cTnI) are
proteins released into the bloodstream after cardiac injury. Myoglobin is a heme-protein
normally found in skeletal and cardiac muscle with a molecular weight of 17.8 kDa.1 When
muscle cells are damaged, Myoglobin is released into the blood rapidly due to its relatively
small size. The level of Myoglobin increases measurably above baseline within 2-4 hours
post-infarct, peaking at 9-12 hours, and returning to baseline within 24-36 hours.2,3 CK-MB
is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa.4
Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and
“B”, which combine to form three different isoenzymes, CK-MM, CK-BB and CK-MB.
CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac
muscle tissue.5 The release of CK-MB into the blood following an MI can be detected
within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to
baseline levels within 48 to 72 hours.6 Cardiac Troponin I is a protein found in cardiac
muscle, with a molecular weight of 22.5 kDa.7 Troponin I is part of a three subunit complex
comprised of Troponin T and Troponin C. Along with tropomyosin, this structural complex
forms the main component that regulates the calcium sensitive ATPase activity of
actomyosin in striated skeletal and cardiac muscle.8 After cardiac injury occurs, Troponin I
is released into the blood 4-6 hours after the onset of pain. The release pattern of
Troponin I 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 combined detection of three myocardial injury markers including CK-MB, cTnI and
myoglobin has better sensitivity and specificity, which makes the diagnosis more accurate.
To achieve early diagnosis, early treatment, reduce missed diagnosis and timely risk
stratification of patients.
The Troponin I/Myoglobin/CK-MB (3 in 1) Test Cassette (Whole
Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated
particles and capture reagent to detect cardiac Troponin I, Myoglobin and CK-MB in whole
blood, serum or plasma.
【PRINCIPLE】
The FIATESTTM Troponin I/Myoglobin/CK-MB (3 in 1) Test Cassette (Whole
Blood/Serum/Plasma) detects cardiac Troponin I, Myoglobin and CK-MB based on
Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad. If the specimen contains cTnI, Myoglobin or CK-MB, it attaches to the
fluorescent microspheres-conjugated specific antibodies. Then the complex will be
captured by the capture antibodies coated on the nitrocellulose membrane (Test line). The
concentration of cTnI, Myoglobin and CK-MB in the sample correlates with the
fluorescence signal intensity captured on the Test line. According to the fluorescence
intensity of the test and product standard curve, the concentration of cTnI, Myoglobin and
CK-MB in the sample can be calculated by Analyzer to show cTnI, Myoglobin and CK-MB
concentration in specimen.
【REAGENTS】
The test kit includes cTnI antibody coated fluorophores, Myoglobin antibody coated
fluorophores, CK-MB antibody conjugated fluorophores and capture reagents 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 FIATESTTM Troponin I/Myoglobin/CK-MB (3 in 1) 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.
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 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.
【MATERIALS】
Materials Provided
• Test Cassettes • Specimen Collection Tubes with Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge
• Pipette
【DIRECTIONS FOR USE】
Refer to FIATESTTM 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.Serum/plasma: Transfer 75 μL serum/plasma into the buffer tube, mix the specimen
and the buffer well.
Whole blood: Transfer 75 μL whole blood into the buffer tube with pipette; mix the
specimen and the buffer well.
4.Add diluted specimen with a Pipette: Pipette 75 μL diluted specimen into the sample
well. Start the timer at the same time.
5. There are two test modes for FIATESTTM Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
FIATESTTM 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 FIATESTTM Fluorescence Immunoassay Analyzer.
The result of tests for cTnI, Myoglobin and CK-MB 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.
Linearity range of Myoglobin Test is 5~200 ng/mL.
Linearity range of CK-MB is 0.2-75 ng/mL.
