Carcinoembryonic Antigen (CEA) Rapid Test

INTENDED USE

The Carcinoembryonic antigen (CEA) Rapid Testis a rapid chromatographic immunoassay for the qualitative detection of carcinoembryonic antigen (CEA) in human whole blood, serum or plasma specimen. This kit is intended for use as an aid in the diagnosis of various cancers.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (1530°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level Label the device with patient or control identification. For best results, the assay should be performed within one hour.

1. 2. Transfer 3 drops of whole blood/serum/plasma to the specimen well (S) of the device with the provided disposable pipette, and start the timer.

OR

Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane. 

3. 3. If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).
4. 4. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

5. INTERPRETATION OF RESULTS
   
   

   POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

   NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

   INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

   NOTE:

   1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
   2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

   3. LIMITATIONS OF THE TEST

      1. The Carcinoembryonic antigen (CEA) Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human CEA. No meaning should be inferred from the color intensity or width of any apparent bands.

      1. 2. The Carcinoembryonic antigen (CEA) Rapid Testwill only indicate the presence of human CEA in the specimen and should not be used as the sole criteria for the diagnosis of various cancers.
      2. 3. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time rule out the possibility of cancer, as CEA may be present below the minimum detection level of the test.
      3. 4. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
      4. 5. This test can NOT be used to guide the diagnosis of pair trisomy 21.
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