CA 19-9 ELISA Kit (Cancer Antigen 19-9)
INTENDED USE
Human CA 19-9 ELISA kit can be used for analysing in vitro quantitative concentrations of cancer antigen 19-9 (CA 19-9, carbohydrate antigen 19-9, CA19-9, sialylated Lewis A antigen) in human serum and plasma (EDTA and heparin). This assay has a minimum sensitivity limit of 0.2 U/ml.
BACKGROUND
Cancer antigen 19-9 can also be known as tumor sialylated Lewis A antigen, carbohydrate antigen 19-9, CA19-9 or CA 19-9. It is a tumor marker or a tumor-associated antigen which is the predominant marker used in pancreatic cancer management. First discovered in the serum of colon and pancreatic cancer patients. Elevated levels are often found in the serum samples of patients having cancer of the pancreato-biliary system (this includes; pancreas, biliary tract and gallbladder).
Elevated levels of CA 19-9 are identified many cancers (for example lung and a number of other gastrointestinal cancers such as; esophageal, colorectal and hepatocellular carcinoma). Apart from cancer, levels are elevated in cirrhosis, pancreatitis and diseases of the bile ducts.
CONTENT
All reagents supplied need to be stored at 2 °C – 8 °C ,unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
- Microtiterwells: Coated with anti-CA 19-9 antibody (monoclonal).
- Zero Standard.
- Standard (1-5): Concentrations 15, 30, 60, 120, 240 U/mL.
- Control High (Lyophilized).
- Control Low (Lyophilized).
- Assay Buffer.
- Enzyme Conjugate.
- Substrate Solution: Tetramethylbenzidine (TMB).
- Stop Solution: Contains 0.5 M H2SO4, Avoid contact with the stop solution. It may cause skin irritations and burns.
- Wash Solution (40x Concentrated).
SENSITIVITY
The minimum detection sensitivity level of human cancer antigen 19-9 (CA19-9, sialylated Lewis A antigen or carbohydrate antigen 19-9) using current CA 19-9 ELISA kit was 0.2 U/ml. The dynamic range for this assay is 15.0 – 240.0 U/ml.
ASSAY CHARACTERISTICS
– Assay Dynamic Range: 0.26 – 240 U/mL
– Analytical Sensitivity: 0.26 U/mL
– Specificity of Antibodies (Cross Reactivity): None
– Intra Assay: 8.4 – 9.6%
– Inter Assay: 8.2 – 12.2%
– Inter Lot: 1.0 – 10.1%
– Recovery: 85.5 – 98.5%
– Linearity: 93.1 – 114.7%
– High-Dose-Hook Effect: No hook effect was observed up to 15,360 U/mL of CA 19-9.
– Drug Interference: None
– Interfering Substances: Haemoglobin (up to 4 mg/mL), Bilirubin (up to 0.5 mg/mL) and Triglyceride (up to 30 mg/mL) have no influence on the assay results.
REFERENCES
- CA 19-9: Biochemical and Clinical Aspects. Adv Exp Med Biol. (2015) 867: 247-60. Review. Scarà S., et al.
- Biomarkers in pancreatic cancer: diagnostic, prognostic, and predictive. Cancer J. (2012) 18 (6): 530-8. Review. Fong Z.V. and Winter J.M.
- Serum tumor markers in bile duct cancer–a review. Biomarkers. (2014) 19 (6): 437-43. Review. Grunnet M. and Mau-Sørensen M.
ADDITIONAL INFORMATION
- Full Name: CA 19-9 ELISA Kit (Cancer Antigen 19-9)
- Reactivity: Human
- Sample Type: Plasma, Serum
- Sensitivity: 0.2 U/ml
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