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.
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.
Specimen Collection
Fingertip Specimens (Whole Blood)
☀ Clean the area to be lanced with an alcohol swab.
☀ Squeeze the end of the fingertip and pierce it with a sterile lancet.
☀ Wipe away the first drop of blood with sterile gauze or cotton.
☀ Use micropipet to obtain a moderate amount of fresh blood .
Plasma
☀ Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
☀ Separate the plasma by centrifugation.
☀ Carefully withdraw the plasma for testing, or label and store sample in 5 days at 4℃. Plasma may be frozen at -20℃ for up to 3 months.
Serum
☀ Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
☀ Allow the blood to clot.
☀ Separate the serum by centrifugation.
☀ Carefully withdraw the serum for testing or label and store sample in 5 days at 4°C. Serum may be frozen at -20℃ for up to 3 months.
Assay Procedure
☀ Bring the test to room temperature; Remove the test card from the foil pouch and place on a clean dry surface.
☀ Take the fresh whole blood/serum/plasma without pretreatment; bring 2~8℃stored specimen to room temperature for test.
☀ Remove the sample diluent, blending and set aside.
☀ 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.
☀ 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
☀ Test results in the reference value, indicates that the body did not occur related diseases of CEA abnormal expression.
☀ 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.
☀ 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.
☀ 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.
Materials Required But Not Provided
☀ Clock or Timer
☀ Centrifuge tube
Reagents and Materials Provided
☀ One pouched cassette with desiccant.
☀ One instruction.
☀ One bottle of buffer.
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).
Warning and Precautions
☀ FOR PROFESSIONAL USE AND IN VITRO DIAGNOSTIC USES ONLY
☀ Do not reuse the test devices. Discard it in the dustbin after single use.
☀ Do not touch the membrane locate in the windows.
☀ Do not use the test one hour after the pouch was opened .
Performance Characteristics
Analysis sensitivity: 5ng/mL
Analysis Specificity:Have no cross-react with 400ng/mL AFP, 120ng/mL prostate specific antigen, 500ng/mL ferritin.Human body protein which has obvious cross reaction with this product has not been found.
Accuracy: the deviation of the value of the quality control points and the calibration value is not higher than 15%.
Linearity of dose-response curve: In 0-150ng/mL detection range, correlation coefficient (r) is no less than 0.975; absolute deviation of two control point (0ng/mL &5ng/mL) is no more than ±0.5; relative deviation of control point 10ng/mL, 25ng/mL, 75ng/mL and 150ng/mL is no more than ±15%.
Intra-lot imprecision: the coefficient of variation (CV) should not be higher than 15%.
Inter-lot imprecision: the coefficient of variation (CV) should not be higher than 20%.
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