INTENDED USE

The CEA Gold Rapid Screen Test (RST) is a chromatographic immunoassay for the detection of cancer embryo antigen (CEA) in human serum or plasma.

PRINCIPLE

A correlative antigen to intestinal cancer, it can be used to assay the curative effect and prognosis of colon cancer.To some malignant cancer or pulmonary carcinoma outside of the intestine, the concentration of CEA in serum is ahigh. In clinical, CEA is taken as an early index to colon cancer, carcinoma of stomach, rectal cancer, cancer ofesophagus and relapse of cancer after the operation.

The CEA RST is a chromatographic immunoassay (CIA) for the detection of CEA in human serum or plasma.Specific antibody against CEA re-coated onto membrane as a capture reagent on the test region. During the test,specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies.If CEA present, a pink colored band will develop on the membrane in proportion to the amount of CEA presented inthe specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as aprocedural control, a pink colored band in the control region will always appear regardless the presence of CEA.This RST is convenient, easy to read, sensitive, rapid and credible diagnostic kit that suitable to all levels of hospitals and medical and hygienical institutions.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. One piece of operating instruction.

3. One bottle of whole blood chasing buffer.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic use only.

2. Do not use after expiration date.

3. Test device should remain sealed until use.

4. The device stored at 4°C should be balanced to room temperature prior to use.

5. Desiccant in the sealed pouch, don’t eat it.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).