Carcinoembryonic antigen is a small protein or antigen found in tissues of developing fetus, then becomes very low or disappears after birth. The normal range of CEA levels in healthy adults is 0 – 2.5 ng/ml.  CEA levels increase in the blood of some cancer patients as CEA is found on the surface of many types of cancer cells. While CEA doesn’t indicate the type of cancer the patient may have, CEA levels increase in rectal colon cancer patients. After successful resection of the tumor, CEA levels will decrease back to normal. Understanding the CEA blood levels in patients is therefore useful in cancer screening and treatment efficacy.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests


  •  Working range: 0.5-500.0 ng/mL


 Intra-lot Precision

  •  Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot.  CV ≤ 15%.

Inter-lot Precision

  •  Inter-lot precision was determined by testing of CEA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.


  • CEA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.


  • A serial concentration of CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

Hook Effect

  •  There is no Hook effect when the level is 100000.0 ng/mL.

Reagents and Materials provided:

  1. Individually sealed foil pouches containing:
    1.  One test device
    2.  One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

Materials required but not provided:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator