CA-125 ELISA Kit (Cancer Antigen 125)

INTENDED USE

Human CA-125 ELISA kit is designed for measuring in vitro quantitative levels of cancer antigen 125 (CA-125, carcinoma antigen 125, mucin 16, CA125, carbohydrate antigen 125, MUC16, ) in human plasma and serum. This assay has a minimum sensitivity limit of 0.25 U/ml.

BACKGROUND

Cancer antigen 125 (also known as CA-125, carbohydrate antigen 125, CA125, carcinoma antigen 125, mucin 16 or MUC16), is a vital biomarker which is elevated in the blood of many patients having specific types of cancers or in some cases other benign conditions. In women who have primary epithelial ovarian carcinoma and have undergone first-line therapy, an assay value that is equal to or greater than 35 U/mL was found to indicate the presence of residual tumor.

CA-125 is the most frequently used marker for the detection of epithelial ovarian cancer (including stage I disease), and more than 90% of women who are at the advance stage display elevated levels of it in their blood.  It has also be useful in monitoring how the cancer is responding to treatment and predicting the prognosis of the after treatment.

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 125 antibody (monoclonal).
• Zero Standard.
• Standard (1-5): Concentrations 25, 75, 150, 300, 600 U/ml.
• Control Low.
• Control High.
• Enzyme Conjugate.
• Substrate Solution: Tetramethylbenzidine (TMB).
• Stop Solution.
• Wash Solution (40x Concentrated).

SENSITIVITY

The minimum detection sensitivity level of human cancer antigen 125 (carcinoma antigen 125, CA125, MUC16, mucin 16) using current CA-125 ELISA kit was 0.25 U/ml. The dynamic range for this  assay is 25.0 – 600.0 U/ml.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 0.25 – 600 U/mL
– Analytical Sensitivity: 0.25 U/mL
– Specificity (Cross Reactivity): CA-125 (100%), CA 19-9 (0%), CEA (0%), CA 72-4 (0%).
– Intra Assay: 4.50 – 5.9%
– Inter Assay: 6.5 – 13.8%
– Inter Lot: 1.2 – 10.6%
– Recovery: 89.1 – 99.8%
– Linearity: 88.7 – 113.3%
– High-Dose-Hook Effect: No hook effect was observed up to 19,200 U/mL of CA 125.
– 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

REFERENCES

1. The Role of CA 125 as Tumor Marker: Biochemical and Clinical Aspects. Adv Exp Med Biol. (2015) 867: 229-44. Review. Bottoni P. and Scatena R.
2. Use of Biomarkers in Screening for Cancer. Adv Exp Med Biol. (2015) 867: 27-39. Review. Duffy M.J.
3. Carbohydrate antigen-125: a new biomarker in heart failure. Cardiol Rev. (2013) 21 (1): 23-6. Review. Vizzardi E., et al.
4. The role of CA 125 in screening for ovarian cancer. Int J Biol Markers. (1998) 13 (4): 216-20. Review. Rosenthal A.N. and Jacobs I.J.

ADDITIONAL INFORMATION

• Full Name: CA-125 ELISA Kit (Cancer Antigen 125)
• Reactivity: Human
• Sample Type: Serum, Plasma
• Sensitivity: 0.25 U/ml

OTHER RELATED ELISA KITS

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