Applications:

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CEA in whole blood, serum or plasma to aid in monitoring of cancer patients.

Description:

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.

How to 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.

INTERPRETATION OF RESULTS

(Please refer to the illustration)

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).

*NOTE: The intensity of the color in the test line region (T) will 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: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Cat. No.	Product Description	Specimen	Format	Kit Size	Cut-Off	Status

TCE-402	CEA Rapid Test Cassette	WB/S/P	Cassette	40 T	5ng/mL	CE

Tag:

Place of Origin:	China
Brand Name:	AllTest
Certification:	CE, ISO13485
Model Number:	Cassette (TCE-402)

Minimum Order Quantity:	N/A
Price:	Negotiation
Packaging Details:	40 cassette/box
Delivery Time:	2-4 Weeks
Payment Terms:	Ex works
Supply Ability:	10 M tests/month

Format:	Cassette	Specimen:	Feces
Accuracy:	99.1%	Certificate:	ISO13485,CE
Storage:	2-30℃	Shelf Time:	24 Months
Cut-off:	5 Ng/ml
Highlight:	rapid diagnostic test kits , cancer diagnostic tests

	Hangzhou AllTest Biotech CO.,LTD
	#383, Qiaoxin Road, Xiasha Street, Qiantang Disctrict, Hangzhou, Zhejiang, P.R.China
	86-571-56267891
	selina.wu@alltests.com.cn

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