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

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 (CA 15-3, CA15-3 and carcinoma antigen 15-3) is a used to monitor how patient respond to breast cancer treatment and to follow-up on breast cancer recurrence. It 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 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 endocine therapy or cytotoxic drugs. This provides a clear indication that early detection 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.

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.
• 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, cancer antigen 15-3) using current 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

– 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. MUC1 (CD227): a multi-tasked molecule. Cell Mol Life Sci. (2015) 72 (23): 4475-500. Review. Apostolopoulos V., et al.

ADDITIONAL INFORMATION

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

OTHER RELATED ELISA KITS

• Cancer Antigen 19-9 ELISA Kit
• Cancer Antigen 72-4 ELISA Kit
• Carcinoembryonic Antigen (CEA) ELISA Kit