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Flourescence Immunoassay Test Kits
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Flourescence Immunoassay Test cassette for Cardiac Troponin T Detection in Whole Blood/Serum/Plasma

Flourescence Immunoassay Test cassette for Cardiac Troponin T Detection in Whole Blood/Serum/Plasma

Brand Name: ALLTEST Novatrend Plus
Model Number: FI-CTNT-402
MOQ: N/A
Price: negotiation
Payment Terms: Ex works
Detail Information
Time To Result:
15 Minutes
Sample:
Whole Blood/Serum/Plasma/Tissue
Sensitivity:
High
Pack:
10T/25T
Type:
Diagnostic Test Kits
Storage:
2-30℃
Test Type:
Flourescence Immunoassay
Shelf Time:
24months
Test Range:
0.2-40 Ng/mL
Highlight:

mouse monoclonal antibodies

,

hybridoma Monoclonal antibodies

Product Description
The Cardiac Troponin T Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro
quantitative determination of human cardiac Troponin T in whole blood, serum or plasma as an
aid in the diagnosis of Myocardial Infarction (MI).
【SUMMARY】
Cardiac Troponin T(cTnT) is a structurally bound protein found in striated muscle cells with a
molecular weight of 37kD.1 Troponin T is part of a three subunit complex comprising of Troponin
I 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.2 After acute myocardial infarction (AMI), serum cTnT levels are elevated 2 to 8 hours
after onset, peak in 12-24 hours and can persist for up to 14 days.3 Cardiac Troponin T(cTnT) as
currently recognized as the most valuable diagnostic index for myocardial injury, has shown
broad application prospects and replaced creatine phosphate kinase MB isoenzyme (CK-MB) as
the "gold standard" for judging myocardial injury, especially for diagnosing acute myocardial
infarction. It plays an important role in the diagnosis of heart failure, unstable angina pectoris,
myocarditis, drug-induced myocardial injury, cardiac injury monitoring in thoracic surgery,
various critical diseases and multiple organ failure.4
The Cardiac Troponin T Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes
a combination of anti-cTnT antibody coated particles and capture reagent to detect cTnT in
whole blood, serum or plasma.
【PRINCIPLE】
The Cardiac Troponin T Test Cassette (Whole Blood/Serum/Plasma) detects cardiac Troponin T
(cTnT) based on Fluorescence Immunoassay. The sample moves through the strip from sample
pad to absorbent pad. If the specimen contains cTnT, it attaches to the fluorescent
microspheres-conjugated anti-cTnT antibodies. Then the complex will be captured by the
capture antibodies coated on the nitrocellulose membrane (Test line). The concentration of cTnT
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 cTnT in
the sample can be calculated by  Analyzer to show cTnT concentration in specimen.
【REAGENTS】
The test kit includes anti-cTnT antibody coated fluorophores and anti-cTnT 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 cTnT 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°C). 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 (75μL 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
• 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. Serum/plasma: Transfer 75μL of serum/plasma into the buffer tube; mix the specimen and
the buffer well.
Whole blood: Transfer 75μL of whole blood into the buffer tube with pipette; mix the
specimen and the buffer well.
4. Add diluted specimen with a Pipette: Pipette 75μL of diluted specimen into the sample
well. Start the timer at the same time.
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 cTnT 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 cTnT Test is 0.2-40 ng/mL.