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CANCER ANTIGEN (CA) 125
Message"It is suggested that the assay not be performed until at least three weeks after the completion of primary chemotherapy and at least two months following abdominal surgery.
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Test Code
2303
Alias/See Also
"CA-125, Second Generation Assay
CA125
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CA125
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CPT Codes
86304
Preferred Specimen
serum 0.8 mL
Minimum Volume
"0.3 mL (Note: This volume does not allow for repeat testing.)
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Instructions
"If a red-top tube is used, transfer separated serum to a plastic transport tube.
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Transport Container
"Red-top tube or gel-barrier tube
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Transport Temperature
refrigerated
Specimen Stability
"Room temperature---14 days
Refrigerated---14 days
Frozen---14 days
Freeze/thaw cycles---Stable x3"
Refrigerated---14 days
Frozen---14 days
Freeze/thaw cycles---Stable x3"
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Citrate plasma specimen; improper labeling
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Methodology
"Electrochemiluminescence immunoassay (ECLIA) "
Limitations
"The measured CA 125 value of a patient's sample can vary depending on the test procedure used. The laboratory finding must, therefore, always contain a statement on the CA 125 assay method used. CA 125 values determined on patient samples by different test procedures cannot be directly compared with one another and could cause erroneous medical interpretations.
In patients receiving therapy with high biotin doses (eg, >5 mg/day), no sample should be taken until at least eight hours after the last biotin administration.1 As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes.1 In rare cases, interference due to extremely high titers of antibody to streptavidin and ruthenium can occur. The test contains additives that minimize these effects.1
For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.
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In patients receiving therapy with high biotin doses (eg, >5 mg/day), no sample should be taken until at least eight hours after the last biotin administration.1 As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes.1 In rare cases, interference due to extremely high titers of antibody to streptavidin and ruthenium can occur. The test contains additives that minimize these effects.1
For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.
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Reference Range
"0.0-34.0 units/mL
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Clinical Significance
"The Elecsys CA 125 II assay is labeled ""For in vitro diagnostic use"" in the manufacturer's package insert.
This immunoassay is intended for the in vitro quantitative determination of OC 125 reactive determinants in human serum and plasma.1 The Elecsys 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.1 The Elecsys CA 125 II assay is further indicated for serial measurement of CA 125 to aid in the management of cancer patients.1 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 determination CA 125 has a protein structure with associated carbohydrate side-chains.2,3 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).
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This immunoassay is intended for the in vitro quantitative determination of OC 125 reactive determinants in human serum and plasma.1 The Elecsys 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.1 The Elecsys CA 125 II assay is further indicated for serial measurement of CA 125 to aid in the management of cancer patients.1 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 determination CA 125 has a protein structure with associated carbohydrate side-chains.2,3 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).
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