The One Step CEA Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of carcino-embryonic antigen(CEA) in human serum specimen.CEA tests are based on the principle of sandwich immunossay for determination of CEA in human serum specimen.Two monoclonal antibodies are employed to identify CEA specifically. The carcino-embryonic antigen(CEA) is the most commonly tested. when antigen rise beyond the normal range, it can be taken as a signal of cancer or other problems. This one step test is very sensitive and only takes about 15 minutes. Test results are read visually without any instrument.
For serum, collect blood into a container without anticoagulant. If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing.
1.To begin testing; open the sealed pouch by tearing along the notch.Remove the test form the pouch., lay the cassette.
2.Using the plastic pipettor provided, draw two drops of sample into the sample well of the cassette.
3.Wait for colored bands to appear.Read results within 10-
15 minutes. Do not read results after 20 minutes.
INTERPRETATION OF RESULTS
1.Negative: Only one color band appears on the control region.No apparen band on the test region. This indicates that there is no detectable CEA in the serum.
2.Positive: Distinct color bands appears on the control and regions test.Both test line and control line indicate that the specimen contains detectable amount of CEA.
3.Invalid: No visible bang at all or only one colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.
1,Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2,Use it before expiry date.
3,The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
4,Old Serum can not be used. If the serum is thick, it can be used only after being separated.
1,The test is for in-vitro diagnostic use only.
2,The test is qualitative filter detection,it can not be used as the final test for blood donor
STORAGE AND STABILITY
The test kit can be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration.The test kit should be kept away from direct sunlight, moisture and heat.