CA-125-CHECK-1 Quantitative determination of ovarian cancer marker CA-125 in whole blood, plasma or serum samples FOR EASY READER® OR EASY READER+®

Cancer Antigen (CA 125) is a surface antigen associated with epithelial ovarian cancer. In serum, CA-125 is associated with a high molecular weight glycoprotein. Published studies have indicated that elevated serum CA 125 levels can be found in individuals with serious endometroid, clear-cell and undifferenciated ovarian carcinoma (1, 2, 3). The serum CA 125 concentration is greater than 35 U/mL in 60 % of women with ovarian cancer. Most of the studies recommend this level of 35 U/mL as the decision level (4). The serum CA 125 is elevated in 1 % of normal healthy women, 3 % of normal healthy women with benign ovarian diseases, 6 % of patients with non-neoplastic conditions (5) (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 CA 125 as well as pelvic examination increase the test specificity. Serum CA 125 concentration may be useful in monitoring treatment and distinguishing between good response to treatment and progressive malignant disease with poor therapeutic response. CA 125 is a serum tumour marker for monitoring response to chemotherapy, detecting disease recurrence and distinguishing malignant from benign pelvic masses. A rapid fall in CA 125 during the chemotherapy process predicts a favourable prognosis.

Each kit contains

1. CA-125-CHECK-1 reaction devices: 10 20
2. Disposable plastic pipettes: 10 20
3. Diluent dropper bottle: 2.5mL 5 mL
4. Instructions leaflet: 1 1
5. Controls (Optional): Positive control (ref. V7400) and Negative control (ref. V7401): a freeze-dried preparation of a non-infectious compound in diluted human serum, tested and found negative for anti-HIV, anti-HCV and HBs antigen, containing 0.05 % sodium azide is optionally available as a positive and negative control (1x 0.25 mL). The concentration range is indicated on the vial label.