CE certificate Carcino-embryonic antigen rapid test ki

Diagnostic Kit for Carcino-embryonic Antigen (Fluorescence Immunochromatographic Assay)

1.SUMMARY

Carcino-embryonic antigen (CEA) is a glycoprotein produced in colorectal cancer tissue. As an antigen that triggers immune response of patient, it extensively exists in digestive system cancers arise from endoderm, digestive tract tissues of normal embryo and serum of normal subjects. Carcino-embryonic antigen is a broad-spectrum tumor marker, which can indicate existence of different tumors to people. It’s an excellent tumor marker for therapeutic effect judgment, disease progress, monitoring and prognostic estimation of colorectal cancer, breast carcinoma and lung cancer. However, it has less obvious effect on early diagnosis of tumor due to weak specificity and low sensitivity.

2.PRODUCTS INFORMATION 

♦ Name:Diagnostic Kit for Carcino-embryonic Antigen ♦ Model Number: CEA ♦ Methodology: fluorescence immunochromatographic assay ♦ accurancy: 99% ♦ Certificate: CE/ISO13485 ♦ Shelf time : 24 months ♦ after sale service: online technical support ♦ Packing: 25tests/kit,30boxes/ctn ♦ OEM/ODM service :Avaliable ♦ Storage:2'C-30'C

3.FEATURE

♦ Speciments are easy to collect: Human serum/plasma /whool blood  ♦ Easy to carry, Rapid test in 15 mins, Cost effective . ♦ Application:simple operation ,suitable for bedside,outpatient,ICU ,outdoor and so on . ♦ CEA in the blood continued to rise after treatment, indicating potential metastases or the presence of residual tumor. ♦The clinical relevance of CEA detection in the follow-up treatment of colorectal, gastric, breast, lung, prostate, pancreatic and ovarian cancer patients. The results of follow-up studies for patients with colorectal cancer, breast cancer and lung cancer showed that the preoperative CEA level has prognostic significance.

4.TEST PROCEDURE 

♦ Open the aluminum foil bag package of reagent and take out the test device.

♦ Horizontally insert the test device into the slot of immune analyzer.

♦ On home page of operation interface of immune analyzer, click “Standard” to enter test interface.

♦ Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument and select sample type.

Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step.

♦ Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit label.

♦ Take out sample diluent upon consistent information, add 80μL serum/plasma/whole blood sample, and thoroughly mix them;

♦ Add 80µL aforesaid thoroughly mixed solution into well of test device;

♦ After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface.

♦ Immune analyzer will automatically complete test and analysis when test time is reached.

♦ Result calculation and display: after test by immune analyzer is completed, test result will be displayed on test interface or can be viewed

through “History” on home page of operation interface.

5.STORAGE AND STABILITY

♦ The kit is 24 months shelf-life from the date of manufacture. Store the unused kits at 2-30°C. DO NOT FREEZE. Do not use beyond the expiration date.

♦ Do not open the sealed pouch until you are ready to perform a test, and the single-use test is suggested to be used under the required environment (temperature 2-35℃, humidity 40-90%) within 60 mins as quickly as possible.

♦ Sample diluent is used immediately after being opened.

6.CERTIFICATE 

7.FACTORY

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