CA199 Tumor Markers

INTENDED USE

Detection Kit for Carbohydrate antigen 19-9(CA199)(ELISA). It is used in quantitative tests for CA19-9 in human serum.

SUMMARYANDCLINICALSIGNIFICANCE

Carbohydrate antigen 19-9 (CA19-9) is a tumor-associated antigen oligosaccharide and also called pancreatic cancer antigen or sialylated Lewis antigen. CA19-9 is a molecular weight over 5000, 000 and its epitopes is formed of glycoproteins with mucin in serum. CA19-9 present in colorectal cancer cells, and also present in the cancer tissue of pancreas, lung, thyroid, ovary, prostate.

This reagent mainly is used for dynamic monitoring of cancer patients to determine disease progression or auxiliary therapeutic effect, but its concentration is not correlated with tumor size, growth, and the degree of malignancy grading/staging. In some benign diseases (Such as acute pancreatitis, cholecystitis, cholangitis cholestasis, hepatitis, etc.) can also be seen that the index increased in varying degrees. Therefore, the CA19-9 should not be considered an effective general screening test for the general population of cancer screening, early diagnosis and other purposes.

PRINCIPLE

CA-19-9 uses a “sandwich principle”, Enzyme-linked immunological sorbent assay. To measure CA-19-9 levels in serum, plastic wells coated with a monoclonal antibodies of CA-19-9 are supplied in the kit. After the patient’s specimen and another mono-antibody labelled with HRP are added, CA-19-9, if present, is fixed to the solid phase antibody and creating a HRP-antibody—CA-19-9—antibody “sandwich”. After TMB substrate added, the result is obtained by EIAplate reader.

REAGENTSSUPPLIED

Coated Microplate: 1 plate (8 × 12 wells), Ready to use. Coated with anti-CA19-9 antibody and sealed in an aluminum bag. Remove the strips in the resealable bag with a desiccant to protect from moisture after opened. Store at 2~8℃ until expiration date.

HRP Conjugate: 1 vial of 6ml, Ready to use. Containing HRP labeled anti-CA19-9 and proclin-300 preservative. Store at 2~8℃ until expiration date.

Calibrator: 5 vials of 0.5ml, Ready to use. Labeled with S0 to S4and the concentration of CA19-9 is 0,10, 40, 100, 150 U/ml. Store at 2~8℃ until expiration date.

Control: 1 vial of 0.5ml, Ready to use. Store at 2~8℃ until expiration date. The concentration is 39.4~73.2 U/ml.

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

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

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

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.

Plate sealer: 2 pieces.

Plastic resealable bag: 1 set.

Instruction manual: 1 copy.

PREPARATIONS

1. Allow all specimens and reagents to reach room temperature and mix thoroughly by gentle inversion before use.

2. Prepare Wash Buffer by diluting Wash Concentrate 20-fold with deionized

ASSAYPROCEDURE:

1.Mark the microtitration strips to be used. All the calibrators and controls should set duplicate.

2.Dispense 50 ul of calibrators/controls/samples into wells.

3.Dispense 50 ul of HRPConjugateto 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 1 hour.

4.Wash each well for 3 times, 10 seconds each time. (See wash procedure).

5.Dispense 50 ul of chromogen Ato each well.

6.Dispense 50 ul of chromogen B to each well.

7.Covered the strips with a fresh plate sealer.

8.Mix it gently by swirling the microtiter plate on flat bench. Incubate the plate at 37°C for 15 minutes.

9.Dispense 50 ul ofstoppingsolutionto each well and mix completely.

10. Readtheabsorbanceof theplate within 10 minutes. (See read procedure)

PRECAUTION FOR USERS

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