NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
The CEA Gold Rapid Diagnostic Test (RDT) is a chromatographic immunoassay for the detection of cancer embryo antigen (CEA) in human serum/plasma or whole blood.

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 a high. In clinical, CEA is taken as an early index to colon cancer, carcinoma of stomach, rectal cancer, cancer of esophagus and relapse of cancer after the operation.
The CEA RST is a chromatographic immunoassay (CIA) for the detection of CEA in human serum/plasma or whole blood. 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 in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of CEA. CEA RDT is convenient, easy to read, sensitive, rapid and credible diagnostic kit that suitable to all levels of hospitals and medical and hygienic institutions.

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

ASSAY PROCEDURE
Serum or Plasma Sample
Add 70-100 ul or 2-3 drops of serum or plasma into sample well.
Whole Blood Sample
Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 15-20 minutes.

INTERPRETATION OF RESULTS

Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.