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Test Code CA125 CA 125 (Ortho)

Additional Codes

Cerner

NextGen

CA 125 (Ortho)

CA 125 (Ortho)

Alternate Name(s)

Cancer Antigen 125

Useful For

The VITROS CA 125 II (C125a) test is a second generation test for the detection of OC 125 defined antigen on a high molecular weight glycoprotein in serum.

CA 125 test concentrations are elevated in most patients with active epithelial ovarian cancer (OC), including those with stage I disease. 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.

In women with primary epithelial ovarian carcinoma who have undergone first-line therapy and are candidates for diagnostic second-look procedures, a CA 125 test concentration greater than or equal to 35 U/mL has been found to be indicative of the presence of residual tumor. Assuming the physician cannot identify alternative causes for an elevated CA 125 test concentration, a CA 125 test concentration greater than or equal to 35 U/mL provides substantial evidence that residual tumor is present. 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. Clinical decisions should not be based on Vitros CA 125 test concentrations below 35 U/mL.

Methodology

Ortho: Immunometric immunoassay

Patient Preparation

None

Collection Instructions

Standard phlebotomy practices.

Specimen Requirements

Container

Specimen Type

Tube

Lithium Heparin Plasma

PST

 or  or 

Serum

 or 

SST

 or  or 

 

Stability

Storage

Temperature

Stability

Room Temperature

18-28°C

Not recommended

Refrigerated

 2-8°C

≤ 7 days

Frozen

≤-20 °C

≤ 4 weeks

Thaw 1 time only

Rejection Criteria

Gross Hemolysis

Result Reporting and Reference Values

<35 Units/mL

Reflex Testing

None

Limitations

  • Ortho reports no significant effect with the following:
    • Bilirubin up to 20 mg/dL
    • Hemoglobin up to 750 mg/dL
  • Clinical decisions should not be based on CA 125 (Ortho) concentrations below 35 U/mL.