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IVD Tumor Marker CEA rapid test kit Rapid Antigen diagnostic Kit specimen serum/plasma CE certificate
Intended Use of CEA Rapid Test Device
TheCEA Rapid Test Device (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of human carcinoembryonic antigen (CEA) in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of various cancers.
Principle of CEA Rapid Test Device
TheCEA Rapid Test Device (Serum/Plasma) detects human carcinoembryonic antigen (CEA) through visual interpretation of color development on the internal strip. CEA antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with CEA antibodies conjugated to colored particles and precoated onto the sample pad of the test.The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane.If there are sufficient CEA antigens in the specimen,a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicatingthat the proper volume of specimen has been added and membrane wicking has occurred.
Procedure and Result Reading of CEA Rapid Test Device
Intended Use One Step CEA Rapid Screen Test is a rapid direct binding test for the detection of carcinoembryonic antigen in whole blood as an a human tumor marker. The test is based on the principle of sandwich immunoassay for determination of CEA in whole blood. Two monoclonal antibodies are employed to identity CEA specifically. This one step test is very sensitive and only takes about 10-15 minutes. The sensitivity of the test can reach to 5ng/mL. |
SPECIMEN COLLECTION The One Step CEA Rapid Screen Test can be run on whole blood samples. The test works best on fresh samples. |
TEST PROCEDURE 1. Do not open foil pouch until ready to begin testing. Refrigerated test devices should be allowed to come to room temperature (15°- 28°C) before opening the pouch. 2. Remove the device from the protective pouch and label the device with specimen identification. 3. Add 50 ul of fresh blood to the Sample Well (for Card) or Sample Pad (for Dipstick),Then add 2 drops (50 ul) of test running buffer into the sample well or sample pad. 4. Read the result within10- 15 minutes. Do not read results after15 minutes. Observe the colored band developed over the control region indicating the assay is complete. |
NTERPRETATION OF RESULTS Negative: Only one pink band appears on test region. This indicates that there is no CEA in the whole blood. Positive: Two pink bands appear on test region. This indicates that the specimen contains CEA Invalid: If without 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. |
PRECAUTION: 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. STORAGE AND STABILITY The test can be stored at room temperature (18 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.
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LIMITATIONS 1.The test is for in-vitro diagnostic use only. |
