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Rapid Cardiac Panel Test Card
Rapid Cardiac Panel test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of cardiac troponin I (cTnI), CK-MB and Myoglobin in human serum, plasma or whole blood specimens as an aid in the diagnosis of myocardial infarction.
PROCEDURE
1. Bring all materials and specimens to room temperature.
2. Remove the test card from the sealed foil pouch.
3. Place the transfer pipette in the specimen and depress the bulb to withdraw a sample.
4. Hold the pipette in a vertical position over the sample well of the test card and deliver 2 drops (80-100 ul) of sample to each sample well well.
5. Read the result at 15 minutes.
Note: Please deliver sample drop by drop to ensure the best performance.
INTERPRETATION OF RESULTS
Positive:
If two colored bands are visible on any strip of the device within 15 minutes, the test result is positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
Note: Specimens containing very low levels of cardiac markers may develop two color bands over 15 minutes.
Negative:
If test area has no color band and the control area displays a colored band, the result is negative and valid.
Invalid:
If a colored band does not form in the control region of any strip, the test result is invalid. The sample must be re-tested, using a new test device.
If after 15 minutes, you see one of the following results. It may imply the indicated syndrome.
a) MYG-positive/CKMB-positive/TnI-positive
(MYO 100 ng/mL, CK-MB 7.0 ng/mL, Tn I 1.0ng/mL)
Myocardial cell necrosis within the past 12 hours.
b) MYG-positive/CKMB-positive/TnI-negative
(MYO 100 ng/mL, CK-MB 7.0 ng/mL, Tn I
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This device is intended as a
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Package
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Cassette: 25 Tests/Box; 40 Tests/Box;
Strip: 50 Tests/Box; 100 Tests/Box;
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Cassette: 25 Tests/Box; 40 Tests/Box;
Strip: 50 Tests/Box; 100 Tests/Box;
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Cassette: 25 Tests/Box; 40 Tests/Box;
Strip: 50 Tests/Box; 100 Tests/Box;
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Certificate: ISO13485, CE, FSC
INTENDED USE
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