Beckman Coulter 386357 Access OV Monitor Reagent, 100 determinations

Description

Beckman Coulter 386357 Access OV Monitor Reagent Specifications:

• Brand: Access OV Monitor reagent
• Manufacturer: Beckman Coulter 386357
• Country of Origin: United States
• Application: Access OV Monitor Reagent Pack
• For Use With: For Access 2 Immunoassay Systems, UniCel DxC Synchron Access Systems, and UniCel Dxl Access
• Immunoassay Systems
• Test Method: Chemiluminescent Immunoassay
• Test Name: CA 125
• Number of Tests: 100 Tests
• Test Type: Tumor Marker Assay

Beckman Coulter 386357 Access OV Monitor Reagent: INTENDED USE

The Access OV Monitor assay using the beckman coulter 386357 Access OV Monitor reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Beckman Coulter 386357 Access OV Monitor Reagent: SUMMARY AND EXPLANATION

The CA 125 antigen is an epitope on a large mucin-like glycoprotein (MW ~ 1000 kDa) that may be found in elevated concentrations in certain ovarian malignancies. There is no known function for CA 125.CA 125 antigen levels have no proven prognostic value when used for either screening or at time of diagnosis. However, CA 125 antigen levels do correlate with patient status after initial treatment.Serum CA 125 antigen levels may be used as an aid in monitoring the response to therapy for patients with epithelial ovarian carcinoma.

Beckman Coulter 386357 Access OV Monitor Reagent impact on CA-125 antigen levels

The presence of persistently rising CA-125 antigen levels may be correlated with disease progression. Persistently elevated CA 125 antigen levels indicate poor response to therapy, whereas decreasing CA 125 antigen levels may indicate a positive therapeutic response.CA-125 antigen levels are elevated in many patients with epithelial ovarian carcinoma. It may also be elevated in diseases other than epithelial ovarian carcinoma, including other benign or malignant ovarian diseases, such as endometriosis, and in lung cancer and in other non-cancerous conditions such as pregnancy.The Access OV Monitor assay is not recommended as a screening tool.

A value below the cutoff limit does not indicate the absence of residual ovarian cancer. Other clinically acceptable tests and procedures should also be considered in the monitoring of ovarian cancer and good patient management.