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Rapid CEA Test Card is an immunochromatographic assay for the qualitative determination of Carcinoembryonic Antigen (CEA) in human serum, plasma or whole blood specimens.
This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease. The sensitivity of this test is 5 ng/ml.
PROCEDURE OF THE TEST
1.Bring all materials to room temperature before testing
2.Remove the test card from the sealed foil pouch, place it on a flat, dry surface, and label it with patient ID.
3.Using the sample dropper to withdraw the specimen, dispense 2-3 drops (approx 80-120l) of specimen into the sample well.
4.Interpret test results at 10 minutes.
Results after 10 minutes may not be accurate.
INTERPRETATION OF THE TEST
Positive Result:
The presence of two colored bands (T band and C band) within the result window regardless of which band appears first indicates a positive result.
Negative Result:
Presence of one colored band in the control region but absence of a colored band in test region, indicates a negative result.
Invalid Result:
Absence of colored bands in control region, the test is invalid. Re-test the sample with a new test kit.
Sensitivity
The analytical sensitivity of the Rapid CEA Test Card is 5ng/mL.
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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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Package
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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
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Certificate: ISO13485, CE, FSC
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