【INTENDED USE】

The CEA Rapid Test Device is a chromatographic immunoassay for the rapid qualitative determination of CEA in whole blood,serum or plasma.The sensitivity of this test is 5 ng/ml. For professional use.

【SUMMARY】

Carcinoembryonic Antigen (CEA) is a tumour-associated antigen characterised as an oncofetal glycoprotein.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 foetal gut tissue with detectable serum levels essentially disappearing after birth.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 tumour 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.

【DIRECTIONS FOR USE】

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

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

2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens:

Hold the dropper vertically and transfer 1 drop of serum or plasma(approximately 25μL) to the specimen area,then add 1 drop of buffer (approximately 40μL),and start the timer.See illustration below.

For Venipuncture Whole Blood Specimens:

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

For Fingerstick Whole Blood Specimens:

To use a capillary tube:Fill the capillary tube and transfer approximately 50μL of finger stick whole blood specimen to the specimen area of test device,then add 1 drop of buffer (approximately 40μL) 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.