CEA Carcinoma Embryonic Rapid Test (strip/Cassette/Uncut sheet)

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 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 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 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.

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.

1. One piece of operating instruction.

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℃ 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).

SAMPLE COLLECTION AND PREPARATIO

Fingerstick Specimens (Whole Blood)

1. Clean the area to be lanced with an alcohol swab.

2. Squeeze the end of the fingertip and pierce it with a sterile lancet.

3. Wipe away the first drop of blood with sterile gauze or cotton.

4. Use micropipet to obtain about 100 ul fresh blood .

Plasma

1. Have a certified phlebotomies collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2. Separate the plasma by centrifugation.

3. Carefully withdraw the plasma for testing or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1. Have a certified phlebotomies collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2. Allow the blood to clot.

3. Separate the serum by centrifugation.

4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.