Carcinoembryonic Antigen(CEA)

INTENDED USE

Detection Kit for Carcinoembryonic Antigen ( CEA) ( Enzyme-Linked ImmunoSorbent Assay , ELISA).It is used in quantitative tests for Carcinoembryonic Antigen ( CEA) in human serum.

SUMMARYANDCLINICALSIGNIFICANCE

This reagent mainly is used for colon cancer, lung cancer, gastric cancer patients in order to dynamic monitoring of cancer patients to determine disease progression or auxiliary therapeutic effect. Gold and Freedman discovered the carcina-embryonic antigen localized in human digestive system in 1965, and subsequently CEA is identified as a kind of glucoprotein with molecule weight of 15000-200000 daltons. CEA compositions include fucose, mannose, galactose and sialicacid and it is not only a unity from the analysis of the content of carbon-water,physical chemical property and the behavior of immunity. Measurement of serum CEA concentration is widely used as an aid in the prognosis and management of carcinoma patients according their changing the serum CEA concentrations. Furthermore, the measurement of serum CEA concentration can also be used to diagnose whether the liver carcinoma is primary or metastive.

PRINCIPLE

CEA uses a “sandwich principle”, Enzyme-linked immunological sorbent assay. To measure CEAlevels in serum, plastic wells coated with monoclonal antibodies of CEA are supplied in the kit. After the patient’s specimen and another mono-antibody labelled with HRP are added, CEA, if present, is fixed to the solid phase antibody and creating a HRP-antibody—CEA—antibody “sandwich”. After TMB substrate added, the result is obtained by EIAplate reader.

REAGENTSSUPPLIED

1.Remove the strips in the resealable bag with a desiccant to protect from moisture after opened. Store at 2~8℃ until expiration date.

2.HRP Conjugate: 1 vial of 7ml, Ready to use. Containing HRP labeled anti-CEA and proclin-300 preservative. Store at 2~8℃ until expiration date.

3.Calibrator: 6 vials of 1ml, Ready to use. Labeled with S0 to S5 and the concentration of CEAis 0, 5, 10, 20, 40,80ng/ml. Store at 2~8℃ until expiration date.

4.Control: 2 vials of 1ml, Ready to use. Store at 2~8 ℃ until expiration date. The concentration of low value is 5.25~9.75 ng/ml. The concentration of high value is 17.5~32.5 ng/ml. Store at 2~8℃ until expiration date.

5.Chromogen A: 1 vial of 7ml, Ready to use. Containing H2O2. Store at 2~8℃ until expiration date.

6.Chromogen B: 1 vial of 7ml, Ready to use. Containing TMB. Store at 2~8℃ until expiration date.

7.Stop Solution: 1 vial of 7ml, Ready to use. Containing H2SO4. Store at 2~8℃ until expiration date.

8.Wash buffer: 1 vial of 15ml, Concentrate 20-fold, diluting with deionized water before the assay. Containing NaCl, phosphate and tween-20. Store at 2~8℃ until expiration date.

9.Plate sealer: 2 pieces.

10. Plastic resealable bag: 1 set. 11. Instruction manual: 1 copy.

PRECAUTIONFORUSERS

1. Handling should preclude any pipetting by mouth. Use only pipettes with disposable tips for each specimen.

2.Do not mix materials from different master lots. Do not use kit components beyond the expiration date.

3.All materials should be brought to room temperature before use.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world