ACCU-TELL CEA SERUM TEST

Accu-Tell ^®  Rapid CEA Serum Test is a rapid direct binding test for the detection of human carcinoembryonic antigen (CEA) in serum as an aid in the diagnosis of colorectal, breast, lung and pancreas cancers.

Carcinoembryonic Antigen (CEA) is a cell surface glycoprotein, which is always associated with tumor tissue. Increases of CEA in the blood are seen with cancers of the liver, colon and lungs. The elevation of CEA is also useful for diagnosis on other primary carcinomas of entodermal origin, such as stomach and pancreas. Significant elevations may be found with primaries of breast and ovary. High CEA occurs with medullary carcinoma of thyroid. Increased CEA also has been reported with giant cell carcinoma of thyroid and with neuroblastoma.

Progressive elevations of CEA may herald tumor recurrence 3-36 months before clinical evidence of metastases. So, a persistent elevation in circulating CEA following treatment is strongly indicative of occult metastatic and residual diseases.

Accu-Tell ^®  Rapid CEA Test Cassette is based on the principle of sandwich immunoassay for determination of CEA in serum. Monoclonal and polyclonal antibodies are employed to identify CEA specifically. The sensitivity of the test is 5ng/ml.

1.  For in vitro diagnostic use only.

2.  Do not eat or smoke while handling specimens.

3.  Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.

4.  Avoid splashing or aerosol formation.

5.  Clean up spills thoroughly using an appropriate disinfectant.

6.  Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.

7.  Do not use the test kit if the pouch is damaged or the seal is broken.

For serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use the serum for testing. If the specimen can not be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to normal room temperature before testing. Do not freeze and thaw the specimen repeated.

Read the entire procedure carefully prior to performing any tests. Bring all specimens to room temperature prior to testing.

1.  Open the foil pouch and remove the test cassette. Draw about 5 drops sample into the pipette, and dispense it into the sample well on the cassette.

2.  Wait for 10-20 minutes and read results. Do not read results after 30 minutes.

 

1.  Open the foil pouch and remove the test strip. Holding the strip vertically, carefully dip it into the specimen for about 10 seconds. Do not immerse the strip past the maximum line.

2.  Wait for 10 minutes and read results. Do not read results after 30 minutes.

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

Positive: In addition to the control band, a distinct colored band also appears on the test region (T).

Invalid: A total absence of color bands in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.

The test is a qualitative screening assay and is not suggested for quantitative CEA determination.

As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated

The test kit can be stored at room temperature (18 to 30℃) in the sealed pouch for duration of shelf life. The test kit should be kept away from direct sunlight, moisture and heat.

 

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.