Description
Purpose of the Product
Troponin I/Myoglobin/CK-MB Test kit (Colloidal
Gold) detects the amount of Cardiac Troponin I, Myoglobin, and
CK-MB consists in human blood qualitatively. Positive cTnI
normally can be found in early
myocardial infarction. The minimum detectable amount of
RF of the product is *0ng/ ml.
Product name
Common
name: Cardiac Troponin I/Myoglobin/CK-MB Test Kit (Colloidal
Gold)
Name
of commodity: Cardiac Troponin I/Myoglobin/CK-MB Test
Kit
English name：Cardiac
Troponin I/Myoglobin/CK-MB Test Kit (Colloidal Gold)
Principle
Cardiac Troponin I Test Kit
(Colloidal Gold) is using colloidal gold immune chromatography
principle, and the cTnI, MYO, CK-MB conjugates with the colloidal
gold markers respectively, then the conjugate specific binding with
cTnI, MYO, CK-MB antibody on the test strip to emerge the test line
(T line). The dissociative colloidal gold marker move to the
control area to combine with corresponding antibody displays
control line (C line).
Structure
Composition
Troponin I/Myoglobin/CK-MB Test
kit (Colloidal Gold) is composited byPVC panel, suck sample paper, and test
strip. Thetest strip mainly
has colloidal gold marker and cTnI antibody, MYO antibody, and
CK-MB antibody on it.
Sampling
Sampling test subjects venous
blood 1ml or **3 drops from the finger tip, serum or whole blood
obtained after centrifugation
Add anticoagulant to prevent the coagulum of the
sample, and finished the test immediately after sample
collection.
The Sample could
be stored in **8 Celsius degree storage for 3 days.
Test
Place the test board on a flat
table.
Hold the straw vertically to insure the sample
free drops into the sampling hole.
Add 3 drops of the patient's serum or plasma on
the test paper first; add 1 more drop if the liquid do not appear
in *0 seconds.
Read the
results
Read the result in *0 minute to
*5 minutes after the test, the result is invalid after *0
minutes.
The
Interpretation of Test Results
Positive: There are four colored lines appears on the test
strip, and three of them locates in T1 (CtnI), T2 (MYO), and
T3(CK-MB) respectively. The other line is C line. The
quicker the T line appears and the darker the color is, the higher
amount of corresponding indexes in the sample. If there is one
or more than one line in T area appears with C line indicates that
the corresponding index is positive.
Negative: Only C line appears when the result is
negative.
Invalid:The test is invalid when C line does not appear.
Take a second test.
Reference Value
If the
result of the test is positive, the concentration of
cTnI≥2ng/ml, MYO≥*0ng/ml,
and CK-MB≥5ng/ml.
Explanation of the Reading
Result
cTnI:
When myocardium is injured, cTnI releases into blood. **6
hours after the injury, the amount of cTnI starts to
increase. The peak occurs in *4 to *0 hours, and it recovers
in 5 to 7 days. cTnI has high cardiacspecificity and sensitivity, it has been recognized as the most
specific cardiac marker.
MYO:
When myocardium cell is injured, MYO releases rapidly into the
blood, and it increases in *0 minutes to 2 hours after acute myocardio infarction occurs. The peak
occurs in 5 to *2 hours, and it recovers *8 to *0 hours. MYO
does not has cardiac specificity, but it is more sensitive than the
other markers after the infarction. Hence MYO is a potential
early marker.
CK-MB:
A isozyme of CK, and it is mainly exist in myocardium. CK-MB
has higher sensitivity than CK and the positive detection rate is
**0%. CK-MB index increases in 3 to 8 hours after the
infarction and reaches the peak in 9 to *0 hours.
Limitations
This
product only provides qualitative result of cTnI, MYO, and CK-MB in
blood; please use a quantitative reader by our company if a
quantitative result is needed.
The
test result of the product cannot be used as the sole criterion,
and it is only a doctors’ or patients’ reference with comprehensive
judgment.
Negative result could not eliminate the
probability of myocardium injury because the amount of cardiac
marker increases after specific time period of the
injury.
Cautions
1. This product is only used for
in vitro diagnosis
2. This
product only provides qualitative result of cTnI in blood; please
use a quantitative reader by our company if a quantitative result
is needed.
3. Read the instructions and
check the expiry date on the aluminum bag carefully before use,
stop using the product if the aluminum bag is damaged.
4. Use it properly.
Storage and Expiry Period
Packed
cardiac troponin I test kit (colloidal gold) should be stored in a
space which has relative humidity less
than *0% and cooler than *0 Celsius degrees.
Expiry
Period: *4 months
Packaging Specifications
*0
Kits/box
Executive standard:YZB/ E ********2
Registration Certificate of Medical Device
(RCMD):E RCMD ***9
******3
Manufacture Permit of Medical Device
(MPMD):E MPMD
*******8
