Carcinoembryonic Antigen (CEA) is a tumor-associated antigen characterized as an oncofetal glycoprotein. 1 CEA is expressed in a variety of malignancies, particularly pulmonary or gastrointestinal tumors (e.g. colon cancer, liver cancer and lung cancer). CEA normally occurs in fetal gut tissue with detectable serum levels essentially disappearing after birth. 2,3  Therefore, elevated levels of CEA can be of significant value in the diagnosis of primary carcinomas.

In addition to qualitative assessment, CEA testing plays an important role in the monitoring of cancer patients. Clinical evidence indicates that CEA levels can serve as predictive markers in both pre- and post-treatment cancer. Progressive elevation of CEA may signal tumor recurrence 3-36 months before clinical evidence of metastasis. Persistent elevation of circulating CEA following treatment is strongly indicative of occult metastatic and residual diseases and deficient therapeutic response.

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a combination of anti-CEA antibody coated particles and anti-CEA antibodies to detect elevated levels of CEA in whole blood, serum or plasma. The minimum detection level is 5ng/ml.

 

【DIRECTIONS FOR USE】

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

· Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 ul) to the specimen well of test Cassette, then add 1 drop of buffer (approximately 40 ul) and start the

timer. See illustration below.

For Venipuncture Whole Blood specimen:

· Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

· To use a capillary tube: Fill the capillary tube and transfer approximately 50 ul of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.

· To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 ul) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.