Cancer Antigen 125

Test Code
CA125


CPT Codes
86304

Preferred Specimen

Green




Minimum Volume
0.5 mL


Other Acceptable Specimens
Lithium Heparin Plasma (green top) tube


Transport Container

Serum (gold top) tube or Lithium Heparin Plasma (green top) tube



Transport Temperature
Room Temperature or Refrigeration


Specimen Stability
Room Temperature - 1 day; Refrigerated - 7 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Turbidity, Quantity not Sufficient, IV contamination


Methodology
Chemiluminescence

Setup Schedule

Daily upon receipt



Report Available
Upon completion of analysis


Limitations
Individuals receiving mouse immunoglobulin by parenteral routes may produce anti-mouse antibodies. Serum from such individuals may produce erroneous results. This test is not recommended as a screening procedure to detect cancer in the general population. CA-125 test concentrations are elevated in 1 - 2 % of healthy individuals and may be elevated in diseases other than ovarian carcinoma, including both benign and malignant disorders. CA-125 test concentrations greater than or equal to 35 U/mL may be found in patients with non-malignant conditions, such as pericarditis, cirrhosis, severe hepatic necrosis, endometriosis (Stages II - IV), first trimester pregnancy, and ovarian cysts or in patients with non-ovarian malignancies, such as uterine carcinoma, hepatoma, pancreatic adenocarcinoma, and lung cancer. A CA-125 test concentration below 35 U/mL does not indicate the absence of residual ovarian cancer because patients with histiopathologic evidence of ovarian carcinoma may have CA-125 test concentrations within the range of healthy individuals. Clinical decisions for these patients should not be based on a CA-125 test concentration below 35 U/mL. This test should not be performed until at least three weeks after the completion of primary chemotherapy and at least two months after abdominal surgery. This is recommended because it is not clear what effect, if any, these procedures may have on the CA-125 test concentration. For changes in tumor marker concentrations during therapy, progressive disease is defined by an increase of at least 25%. Testing should be repeated within two to four weeks for additional evidence.


Reference Range

0 - 35.0 U/mL



Clinical Significance

Cancer antigen 125 (CA 125) is a glycoprotein antigen normally expressed in tissues derived from coelomic epithelia (ovary, fallopian tube, peritoneum, pleura, pericardium, colon, kidney, stomach). Elevated serum CA 125 levels are seen in many patients with cancer of the ovary; the percentage of positive cases increases with cancer stage. Elevated serum CA 125 levels have been reported in individuals with a variety of nonovarian malignancies including cervical, liver, pancreatic, lung, colon, stomach, biliary tract, uterine, fallopian tube, breast, and endometrial carcinomas. Elevated serum CA 125 levels have been reported in individuals with a variety of nonmalignant conditions including: cirrhosis, hepatitis, endometriosis, first trimester pregnancy, ovarian cysts, and pelvic inflammatory disease. Elevated levels during the menstrual cycle also have been reported. A CA 125 test concentration below 35 U/mL does not indicate the absence of residual ovarian cancer because patients with histopathologic evidence of ovarian carcinoma may have CA 125 test concentrations within the range of healthy individuals.





The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.