99% CEA Fast Test Cassette

Carcino-embryonic Antigen quantitative rapid test kit (Colloidal Gold)

For the quantitative detection of CEA in serum/plasma /whole blood
 

Intended Use

Diagnostic Kit for Carcino-embryonic Antigen (CEA) is a chromatographic immunoassay (CIA) for the quantitative detection of Carcino-embryonic Antigen in serum/plasma and whole blood with the use of NEWSCEN Immuno Assay Reader.

Summary

CEA is a kind of glycoprotein, molecular weight of about 20KD. Under physiological conditions, CEA mainly produced in fetal gastrointestinal epithelial tissue, pancreas, and liver cell. CEA should only be found in adults in very low levels. Pathological changes, colon polyps, ulcerative colitis, pancreatitis, liver cirrhosis, benign or malignant tumor can cause CEA elevation. Some bad habits such as smoking may also cause the increase of the CEA. Because as one cannot specify the causes by the elevated levels of CEA , the test kit can only be used for the detection of CEA anomalies.
 

Principle

Diagnostic Kit for Carcino-embryonic Antigen (CEA) is a double antibody sandwich immunoassay kit for the quantitative testing of Carcino-embryonic Antigen in blood. The membrane was precoated with CEA specific antibodies on the test band region and goat anti mouse IgG on the control band region.

During the test, the specimen is allowed to react with CEA specific antibodies-colloidal gold particles conjugate, which was predried on the test strip.The conjugate binds to the CEA forming an antibody-antigen complex. The complex moves forward on the membrane by the capillary action, then the complex is captured by CEA specific antibody on the test region to produce a visual pink color band. The color band is positive correlated with the concentration of CEA of the specimen.

Regardless of the presence of CEA, as the mixture continues to move across the membrane to the control band region, the complex is captured by immobilized goat anti mouse antibodies to form a distinct pink colored control band.

Composition

The test kit contains CEA Specific antibodies on a colloid gold particles and a combination of CEA Specific antibodies on the membrane.

Reagents and Materials Provided

1. One pouched cassette with desiccant.

2. One instruction.

3. One bottle of buffer.

Materials Required But Not Provided

1. Clock or Timer

2. Centrifuge tube

Warning and Precautions

1. FOR PROFESSIONAL USE AND IN VITRO DIAGNOSTIC USES ONLY

2. Do not reuse the test devices. Discard it in the dustbin after single use.

3. Do not touch the membrane locate in the windows.

4. Do not use the test one hour after the pouch was opened .

Storage

The kits should be stored at a cool dark place at temperature 4-30℃ and, the sealed pouch for the duration of the shelf life (24 months).

Assay Procedure

1. Bring the test to room temperature; Remove the test card from the foil pouch and place on a clean dry surface.

2. Take the fresh whole blood/serum/plasma without pretreatment; bring 2~8℃stored specimen to room temperature for test.

3. Remove the sample diluent, blending and set aside.

4. Add 10μL of serum or plasma or 20L of whole blood into S well, add 80μL of buffer into B well. Read the result with Immuno Assay Reader within 15~20 minutes. Results after 20 minutes may be invalid.

5. Calibration: before read the result, need to confirm that the Reader is in normal state. And the Reader passes the daily photometric calibration. Moreover, before read the cassette, import the standard curve.

Interpretation of Results

1. Test results in the reference value, indicates that the body did not occur related diseases of CEA abnormal expression.

2. The test result is higher than the reference value, indicates that the body has abnormal expression of CEA . There may be some pathological changes, colon polyps, ulcerative colitis, pancreatitis, liver cirrhosis, benign or malignant tumor ,can cause CEA elevation. CEA elevation could not determine the specific cause. In general the results were positively associated with the degree of abnormity.

3. The results > 150ng/mL, indicates that CEA content of sample is higher than the upper limit test range. Recommend repeat testing after appropriate dilution, until you can get the specific concentration values, multiplied by the dilution factor is the sample concentration.

4. Invalid result, no control line observed, retest required.

Quality Control

Diagnostic Kit for Carcino-embryonic Antigen has included a procedural control in the test. If a test kit is valid and assay was performed properly a pink colored band will always appear in the membrane regardless the test result.