Product Description
Creatine Kinase Isoenzyme
MB (CK-MB) Test Kit (Fluorescence
Immunochromatography)
1. Introduction
Creatine Kinase Isoenzyme MB (CK-MB) is one form of Creatine Kinase
(CK). The normal range in blood is less than 5ng/ml, which is not
detected in normal blood, or only trace CK-MB is present. Only
after myocardial injury, the myocardial cell ruptured and creatine
kinase released from the myocardial cell and absorbed into the
blood, can the creatine kinase be detected in blood sample, which
indicates the presence of myocardial injury. Singclean® Creatine
Kinase Isoenzyme MB (CK-MB) Test Kit (Fluorescence
Immunochromatography) is used for quantitative determination of
Creatine Kinase Isoenzyme MB (CK-MB) range in human serum, plasma
or whole blood samples in vitro as the mark of myocardial
infarction.
2. Indications for Use
This kit is used for the quantitative determination of Creatine
Kinase Isoenzyme MB (CK-MB) in human serum, plasma or whole blood
samples in vitro.
There are four isozyme forms of Creatine Kinase (CK): muscle type
(MM), brain type (BB), mixed type (MB) and mitochondrial type
(MiMi), among which MB type is mainly present in myocardial cells.
In myocardial infarction, creatine kinase increases within 6 hours
of onset, peaks at *4 hours, and returns to normal within 3~4 days.
Among them, Creatine Kinase Isoenzyme MB has high diagnostic
specificity, so it has become one of the markers of myocardial
infarction.
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3. Who should have a MB (CK-MB) Test?
Unnormal range of MB (CK-MB) in blood is the sign of myocardial
infarction.
If you have symptoms like angina, arrhythmia, heart failure and
compressive pain or tightness in precordium that lasts more than *0
minutes and it is suggested to have a MB (CK-MB) testing.
By testing the MB (CK-MB) in blood, we can know whether a persons
MB (CK-MB) range is more than 5ng/ml, which means the likelihood of
myocardial infarction. For those people whose MB (CK-MB) range is
more than 5ng/ml, it shows they have the risk of myocardial
infarction, and they should go for a timely medical treatment.
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4. Singclean Advantages:
Accurate:the fluorescence immunochromatography
method based test kit has higher accuracy.
Easier to read:based on fluorescence
immunochromatography, easier to read test result than colloidal
gold immunochromatography.
Easy for storage:it can be stored at room
temperature (4
℃~*0
℃).
Longer validity period: *8 months of validity
period.
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5. Product performance index
a)Â Â Â Â Â Accuracy: The recovery
rate is between *5% and **5%.
b)Â Â Â Â Linear range: within the linear
range of 2.5ng/mL~*0ng/mL, the linear correlation coefficient
r≥0.***0;
c)Â Â Â Â Â Blank limit: not higher
than 2.5ng/mL;
d)Â Â Â Â Precision:
In-batch precision: The coefficient of variation (CV) is
not more than *5%;
Precision between batches: The relative range between
batches is not more than *5%.
6.Specification
Creatine Kinase Isoenzyme MB (CK-MB) Test Kit (Fluorescence
Immunochromatography)
Format: *0 tests/box, *0 tests/box, *5 tests/box, *0 tests/box, *0
tests/box, **0 tests/box.
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7. Main
components
No.
|
Name
|
Component
|
1
|
Creatine Kinase
Isoenzyme MB (CK-MB) Test Kit (Fluorescence
Immunochromatography)
|
Each bag contains a test
card and a desiccant; the test card consists of shell and a
test strip, and the test strip consists of sample pad,
fluorescent pad (fixed with fluorescently labeled CK-MB
monoclonal antibody 1), Nitrocellulose membrane (coated with
CK-MB monoclonal antibody 2 and goat anti-mouse IgG), filter
paper and PVC plastic sheet
|
2
|
Whole Blood
Diluent
|
1 bottle of diluent for
*0 tests/box, *0 tests/box, *5 tests/box and *0 tests/box; 2
bottles of diluent for *0 tests/box; 4 bottles of diluent for
**0 test/box; 3.0mL/bottle
|
3
|
ID card
|
1 pc/box
|
[Applicable instrument]
Fluorescence immunoassay analyzer
It should be purchased separately and can be used for different
Test Items, like CK-MB, IL6, PCT.
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8. Specimen collection
1. Human serum, plasma or whole blood samples; other body fluids
and samples may not give accurate results.
2. Venous blood or fingertip blood should be collected under
sterile conditions. It is recommended to use human serum or plasma
for testing.
3. Anticoagulation with EDTA, sodium citrate or heparin is
recommended for plasma and whole blood samples.
4. After the clinical blood samples are collected, the test must be
completed within 4 hours at room temperature; serum and plasma can
be stored at 2~8°C for 3 days and stored below **0°C for 5 months.
Whole blood samples should not be frozen and stored at 2~8°C for 3
days. Avoid heat inactivating samples, and hemolyzed samples should
be discarded.
5. Samples must be returned to room temperature before testing.
Refrigerated samples need to be completely thawed, rewarmed, and
evenly mixed before use. Do not freeze and thaw repeatedly.
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9. Test Procedure
Please read the instructions of the test kit and the manual of the
fluorescence immunoanalyzer carefully before use.
a)Â Â Â Â Â Bring the test kit and sample to
be tested to room temperature.
b)Â Â Â Â Â Make sure the ID card matches the
batch number of the kit, and insert the ID card into the card
reading area of the instrument to read the information.
c)Â Â Â Â Â Open the inner package of the test
kit, take out the test card; draw *0μL of serum plasma sample, drop
vertically to the sampling place of the test card, and start
timing; draw *0μL whole blood, drop vertically to the sampling
place of the test card, and immediately add 1 drop of whole blood
diluent at the sampling place and start timing.
d)Â Â Â Â Â After adding the sample, click
"Start Test" on the screen of the fluorescence immunoanalyzer, and
the test card will react at room temperature for *0 minutes; insert
the test card into the test card slot of the fluorescence
immunoanalyzer, and the instrument will automatically test the test
card; The test results can be seen on the display screen of the
fluorescence immunoanalyzer. Click "Print" on the screen to print
the results.
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*0. Interpretation of Results:
(For reference only, not used as clinical diagnostic criteria, test
results need to be combined with other clinical and laboratory data
for clinical diagnosis)
Content of CK-MB (ng/mL)
|
Clinical application advice
|
**5
|
Normal level
|
>5
|
It is suggested that the patient is at risk of myocardial
infarction. Note: CK-MB exceeds the normal level within 4~8
hours after myocardial infarction; peaks within *2~*4 hours;
and returns to normal level in about 3 days.
|
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*1. Limitations
a)Â Â Â Â Â This test kit is only for the test
of human serum, plasma or whole blood samples. Abnormal hematocrit
samples have an impact on the results of the whole blood test. The
test results of serum, plasma and whole blood are not significant
difference when the hematocrit is between *1% and *8%.
b)Â Â Â Â Â The test results need to be
combined with other clinical and laboratory data, and if the CK-MB
test results do not match the clinical assessment, further testing
is required.
c)Â Â Â Â Â False positive results may be
caused by: cross-reaction of antibody-like components in the blood;
some nonspecific components in blood have similar antigenic
determinants to capture fluorescent-labeled antibodies.
d)Â Â Â Â Â Hemoglobin, triglycerides and
bilirubin in the blood sample can interfere with the test results,
with the maximum allowable concentrations being 5g/L, *0g/L and
0.2g/L, respectively.
e)Â Â Â Â Â False negative results may be
caused by: some unknown components shield the antigenic
determinants from binding to the antibody; the unstable CK-MB
antigen gradually degrades with time and temperature and cannot be
recognized by the antibody. Effective test results depend on good
reagent and sample storage environment.
f)Â Â Â Â Â Â Other factors, including
technical reasons, operational errors and other sample factors, may
also cause errors in test results.
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*2. Certification
CE ISO****5
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Country: |
China |
Model No: |
-
|
FOB Price: |
8 ~ 15.5 / Piece (Negotiable)
Get Latest Price
|
Place of Origin: |
China |
Price for Minimum Order: |
8 per Piece |
Minimum Order Quantity: |
1000 Piece |
Packaging Detail: |
Carton Packing with bag packing inside |
Delivery Time: |
6-15days |
Supplying Ability: |
10000 Piece per Day |
Payment Type: |
Other, Western Union, T/T |
Product Group : |
- |