Calbiotech CA125 ELISA

SUMMARY AND EXPLANATION 
Cancer Antigen 125 (CA125) is a surface antigen associated with epithelial ovarian cancer. In serum, CA125 is associated with a high molecular weight glycoprotein. Published studies have indicated that elevated serum CA125 levels can be found in individuals with serious endometroid, clear-cell and undifferentiated ovarian carcinoma. The serum CA125 concentration is greater than 35 units per ml in 60% of women with ovarian cancer and >80% of patients with disseminated ovarian cancer. The serum CA125 is elevated in 1% of normal healthy women, 3% of normal healthy women with benign ovarian diseases, 6% of patients with non-neoplastic conditions (including but not limited to first trimester pregnancy, menstruation, endometriosis, uterine fibrosis, acute salphingitis, hepatic diseases and inflammation of peritoneum, pericardium or pleura). Serial determinations of serum CA125 as well as pelvic examination increase the test specificity. Serum CA125 concentration may be useful in monitoring treatment and distinguishing between good response to treatment and progressive malignant disease with poor therapeutic response. To date, CA125 is the most sensitive marker for residual epithelial ovarian cancer. CA125 may also be elevated in patients with lung, cervical, fallopian tube, and uterine cancer and endometriosis

PRINCIPLE OF THE TEST 
The CA125 ELISA test is an adapted solid phase 1-step sandwich ELISA. Samples, a biotinylated mouse anti-CA-125 capture antibody, and mouse anti-CA-125-HRP conjugate are all added to wells coated with streptavidin. CA-125 in the patient sample binds to the biotinylated capture antibody. The biotinylated capture antibody simultaneously binds to the streptavidin coated plate. Anti-CA-125–HRP enzyme conjugate forms a sandwich around captured CA-125. Unbound antibodies are washed off. TMB substrate is added resulting in the development of a blue color. The concentration of CA-125 is directly proportional to the color intensity developed. A standard curve is generated relating color intensity to CA-125 concentration.

STORAGE AND STABILITY 
1. Store the kit at 2 - 8°C. 
2. Keep microwells sealed in a dry bag with desiccants. 
3. The reagents are stable until expiration of the kit. 
4. Do not expose reagents to heat, sun, or strong light.