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Test Name:
CA 125 II, by ECLIA, Serum or Plasma
- SBMF No:
30225 - Performance Lab Name:
Automated Lab - Test Mnemonic:
CA 125 II - ABN:
May be required – Medical Necessity - CPT Code:
86304 - LOINC Code:
10334-1 - Also Known As:
Ovarian Cancer Marker
Tumor Marker - Spec Type:
Serum - Spec Container:
Gold top (SST) or red top (serum) tube - Alt Spec Type:
Plasma - Alt Spec Container:
Lavender top (EDTA) or green top (lithium heparin) tube - Pref Vol:
1.6 mL - Min Vol:
0.8 mL - Fasting:
No - Spec Collect:
Routine venipuncture - Spec Process:
Serum sample tubes, clot 30 minutes
Promptly centrifuge 15 minutes
Immediately transfer serum or plasma to separate plastic tube
Properly centrifuged gel barrier tube sample does not require transfer of serum to separate tube - Spec Store Transport:
Refrigerated - Spec Stability:
1 week refrigerated (2-8°C)
3 months frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles - Spec Remarks:
Preferred specimen is primary serum sample contained in properly centrifuged gel barrier tube (not necessary to transfer serum to separate tube) - Methodology:
Electrochemiluminescent Immunoassay (ECLIA) - Use:
Detect residual ovarian carcinoma in patients who have undergone first-line therapy
Considered a one-time test to determine the possibility of second look procedures
Note: SBMF provides serial reporting for this test at no additional charge - Clinical Significance:
Immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum and plasma. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential). The CA 125 II assay is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for second-look procedures. The CA 125 II assay is further indicated for serial measurement of CA 125 to aid in the management of cancer patients.
CA 125 belongs to the family of hybridoma-defined tumor markers. The values measured are defined by the use of the monoclonal antibody (MAb) OC 125. The antigenic determinant CA 125 is located on a high-molecular weight glycoprotein (200-1000 kD) isolated from cell culture or serum. The antigenic determinant CA 125 has a protein structure with associated carbohydrate side-chains.
CA 125 is found in a high percentage of non-mucinous ovarian tumors of epithelial origin and can be detected in serum. It does not occur on the surface epithelium of normal ovaries (adult and fetal). Ovarian carcinoma accounts for about 20% of gynecological tumors; the incidence is 15/100,000.
CA 125 has been found in the amnion and in the coelomic epithelium; both of these tissues are of fetal origin. In tissues of adult origin, the presence of CA 125 has been demonstrated in the epithelium of the oviduct, in the endometrium and in the endocervix.
Elevated values are sometimes found in various benign gynecological diseases such as ovarian cysts, ovarian metaplasia, endometriosis, uterus myomatosus and cervicitis. Slight elevations of this marker may also occur in early pregnancy and in various benign diseases (e.g. acute and chronic pancreatitis, benign gastrointestinal diseases, renal insufficiency, autoimmune diseases and others). Markedly elevated levels have been found in benign liver diseases such as cirrhosis and hepatitis. Extreme elevations can occur in any kind of ascites due to malignant disease. Although the highest CA 125 values occur in patients suffering from ovarian carcinoma, clearly elevated values are also observed in malignancies of the endometrium, breast, gastrointestinal tract and various other malignancies.
Although CA 125 is a relatively unspecific marker, it is today the most important tumor marker for monitoring the therapy and progress of patients with serous ovarian carcinoma. At primary diagnosis, the sensitivity of CA 125 depends on the FIGO stage (FIGO = Federation of Gynecology and Obstetrics); higher tumor stages are associated with higher CA 125 levels.
- Reference Range:
0-35 U/mL - Day Run:
Sun-Sat (daily) - Time Run:
As received - Time Reported:
4 hours - Test Type:
TUMOR MARKER
