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Cancer Antigen 15-3 (CA 15-3) ELISA Kit

INTENDED USE

Human CA 15-3 ELISA kit is a procedure for determining in vitro quantitative levels of cancer antigen 15-3 (CA 15-3, carcinoma antigen 15-3 and CA15-3) in human serum and plasma samples. This assay has a minimum sensitivity limit of 0.5 U/ml.

BACKGROUND

Cancer antigen 15-3 (also called CA 15-3, CA15-3 and carcinoma antigen 15-3), is a vital tumor marker which is often used to monitor how well a patient responds to breast cancer treatment and to follow-up on breast cancer recurrence. CA15-3 is derived from MUC1 gene and the associated CA 27-29 are different epitopes that can be present on the same protein antigen product of MUC1 gene. One of the primary uses of cancer antigen 15-3 is to monitor therapy in patients having metastatic disease, this can be present at the initial period of diagnosis or can occur during any time after the primary therapy. There are a large number of findings which indicate that up to 70% of patients with metastases will respond positively to any systemic treatment using endocrine therapy or cytotoxic drugs. This provides a clear indication that early detection of carcinoma antigen 15-3 is vital in order to manage patients for recurrence.

Furthermore, CA 15-3 can be useful for postoperative surveillance of asymptomatic women that have undergone under gone invasive breast cancer surgery. Although, it has been preferentially linked with breast cancer, this is not tissue specific and there have been findings to suggest elevated levels are also present in other different varieties such as colon adenocarcinoma and ovarian cancer.

CA 15-3 ELISA KIT 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 15-3 antibody (monoclonal).
  • Zero Standard.
  • Standards (1-4): Concentrations 25, 50, 100, 200 U/mL.
  • Control Low (Lyophilized).
  • Control High (Lyophilized).
  • Assay Buffer.
  • Enzyme Conjugate: Anti-CA 15-3 antibody conjugated to horseradish peroxidase.
  • Substrate Solution: Tetramethylbenzidine (TMB).
  • Stop Solution.
  • Wash Solution (40x Concentrated).

SENSITIVITY

The minimum detection sensitivity level of human carcinoma antigen 15-3 (CA15-3, CA 15-3 and carcinoma antigen 15-3) using current human CA 15-3 ELISA kit was 0.5 U/ml. The dynamic range for this assay is 25.0 – 200.0 U/ml.

ASSAY CHARACTERISTICS

– Cancer Antigen 15-3 (CA 15-3): ELISA
– Assay Dynamic Range: 0.50 – 200 U/mL
– Analytical Sensitivity: 0.50 U/mL
– Specificity of Antibodies (Cross Reactivity): None
– Intra Assay: 5.2 – 9.7%
– Inter Assay: 7.7 – 14.5%
– Recovery: 85.0 – 114.9%
– Linearity: 88.4 – 111.1%
– 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.
– Drug Interference: None
– High-Dose-Hook Effect: No hook effect was observed up to 12 800 U/mL of CA 15-3.

REFERENCES

  1. CA 15-3: uses and limitation as a biomarker for breast cancer. Clin Chim Acta. (2010) 411 (23-24): 1869-74. Review. Duffy M.J., et al.
  2. Biomarkers in Breast Cancer: Where Are We and Where Are We Going? Adv Clin Chem. (2015) 71: 1-23. Review. Duffy M.J., et al.
  3. Analytical requirements and standardization of CA 15-3. Scand J Clin Lab Invest Suppl. (1995) 221: 102-4. Review. van Dalen A.
  4. MUC1 (CD227): a multi-tasked molecule. Cell Mol Life Sci. (2015) 72 (23): 4475-500. Review. Apostolopoulos V., et al.
  5. CA 15-3 and bone scintigraphy in the follow-up of breast cancer. Int J Biol Markers. (1997) 12 (4): 154-7. Review. Younsi N., et al.

ADDITIONAL INFORMATION

  • Full Name: Cancer Antigen 15-3 (CA 15-3) ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 0.5 U/ml

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