Product Specification

                     Carcinoembryonic Antigen( CEA ) ELISA Test Kit

For in vitro diagnostic and professional use only.

Drug Names

Generic Name: Carcinoembryonic Antigen( CEA ) ELISA Test Kit

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.

Product details

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.

TEST PROCEDURE

• Mark the microtitration strips to be used. Set six wells for calibrators, two wells for controls and other wells for samples.
• Dispense 50 ul of calibrators as well as controls or samples into respective wells.
• Dispense 50 ul of HRP Conjugate to each well.
• Covered the strips with a plate sealer. Mix it gently by swirling the microtiter plate on flat bench. Incubate the plate at 37°C for 30 minutes.
• Wash each well for 5 times, 20 seconds each time. (See wash procedure).
• Dispense 50μl of chromogen A to each well.
• Dispense 50μl of chromogen B to each well.
• Covered the strips with a fresh plate sealer. Mix it gently by swirling the microtiter plate on flat bench. Incubate the plate at 37°C for 15 minutes.
• Dispense 50μl of stop solution to each well and mix completely.
• Read the absorbance of the plate within 10 minutes. (See read procedure)

Important notes

• The kit takes out from the refrigeration environment should be balanced 15-30 minutes in the room temperature then use, ELISA plates coated if has not use up after opened, the plate should be stored in Sealed bag.
• washing buffer will Crystallization separation, it can be heated the water helps dissolve when

dilute . Washing does not affect the result.

• add Sample with sampler Each step, And proofread its accuracy frequently, avoids the experimental error. add sample within 5 min, if the number of sample is much , recommend to use Volley .
• Please make specification curve when you assay, had better make duplicate well, if in the sample the testing material content is excessively high (The sample OD is bigger than the first standard well OD ),please use Sample dilution to dilute certain multiple (n times),then assay. Please multiply total Dilution Times when calculate(×n×5).
• Closure plate membrane only limits the disposable use, in order to avoid the overlapping pollution.
• The substrate please evade the light preservation.
• Please according to use instruction strictly, The test result determination must take the microtiter plate reader as a standard .
• All samples, washing buffer and each kind of reject should according to infective material process.
• This reagent which different batch number component do not mix.
• If it’s different form English instruction, take English instruction as the standard.

Storage and stability

• Store at 2-8℃.

• Seal and return unused reagents to 2-8℃, under which conditions the stability will be retained for 2 months, or until the labeled expiry date, whichever is earlier.