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(CEA) Carcinoembryonic Antigen Test
(CEA) Carcinoembryonic Antigen Test
The One Step CEA Test is a rapid direct binding test for the detection of human carcinoembryonic antigen (CEA) in whole blood, serum or plasma as an aid in the diagnosis of colorectal, breast, lung and pancreas cancers.
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TEST PROCEDURE:
  1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
  2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
  3. Use the pipette to draw and slowly dispense 1drop (25μl) of serum or plasma or 2drops (50μl) of whole blood to the sample well.
  4. Hold the buffer bottle vertically and add 1-2 drops of buffer to the sample well.
  5. Wait for colored lines to appear. Read the test result between 10 ---15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS:

Positive:
Two pink-colored lines appear in the result window, one in the control region "C" and the other one in the test region "T". This indicates a positive result and the CEA having been detected.
Note:
The intensity of the test line (T)may vary depending on the concentration of CEA present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
Negative:
Only the control line appears in the result window. This indicates a negative result and no CEA having been detected.
Invalid:
If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.
NOTE:
Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
SPECIFICATION:
Description Specimen Format Catalog No. Sensitivity Package Size Strip Width Certificate
(CEA) Carcinoembryonic Ag Test Serum/Plasma Strip E40-11 5ng/mL 50 Tests 3.0 mm CE
Cassette E40-20 25 Tests 4.0 mm

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