Test Catalog

Test Id : CA25

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Cancer Antigen 125 (CA 125), Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating individuals' response to ovarian cancer therapy

 

Predicting recurrent ovarian cancer

 

This test is not useful for cancer detection screening in the normal population.

Method Name
A short description of the method used to perform the test

Electrochemiluminescent Immunoassay (ECLIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Cancer Ag 125 (CA 125), S

Aliases
Lists additional common names for a test, as an aid in searching

CA125 (Cancer Antigen 125)

Cancer Antigen 125

Carbohydrate Antigen 125

OV Monitor

Ovarian Cancer-Related Antibodies

Cancer Ag 125 (CA 125), Serum

CA25

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 5 days
Frozen 168 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating individuals' response to ovarian cancer therapy

 

Predicting recurrent ovarian cancer

 

This test is not useful for cancer detection screening in the normal population.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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).

 

Serum CA 125 is elevated in approximately 80% of women with advanced epithelial ovarian cancer, but the assay sensitivity is suboptimal in early disease stages. The average reported sensitivities are 50% for stage I and 90% for stage II or greater.

 

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 benign conditions including: cirrhosis, hepatitis, endometriosis, first trimester pregnancy, ovarian cysts, and pelvic inflammatory disease. Elevated levels during the menstrual cycle also have been reported.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Males: Not applicable

Females: <46 U/mL

Interpretation
Provides information to assist in interpretation of the test results

In monitoring studies, elevations of cancer antigen 125 (CA 125) above the reference interval after debulking surgery and chemotherapy indicate that residual disease is likely (>95% accuracy). However, normal levels do not rule out recurrence.

 

A persistently rising CA 125 value suggests progressive malignant disease and poor therapeutic response.

 

Physiologic half-life of CA 125 is approximately 5 days.

 

In individuals with advanced disease who have undergone cytoreductive surgery and are on chemotherapy, a prolonged half-life (>20 days) may be associated with a shortened disease-free survival.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Results cannot be interpreted as absolute evidence of the presence or absence of disease.

 

Serum markers are not specific for malignancy and values may vary by method. Values obtained with different assay methods cannot be used interchangeably.

 

Some individuals have antibodies to mouse protein (HAMA), which can cause interference in immunoassays that employ mouse antibodies. In particular, it has been reported that serum specimens from patients who have undergone therapeutic or diagnostic procedures that include infusion of mouse monoclonal antibodies may produce erroneous results in such assays. Rerunning the specimen in question after additional blocking treatment may resolve the issue.

 

No interference was observed from rheumatoid factors up to a concentration of 1200 IU/mL.

 

There is no high-dose hook effect at cancer antigen 125 concentrations of up to 50,000 U/mL.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Zhang M, Cheng S, Jin Y, Zhao Y, Wang Y. Roles of CA125 in diagnosis, prediction, and oncogenesis of ovarian cancer. Biochim Biophys Acta Rev Cancer. 2021;1875(2):188503. doi: 10.1016/j.bbcan.2021.188503

2. Charkhchi P, Cybulski C, Gronwald J, Wong FO, Narod SA, Akbari MR. CA125 and Ovarian Cancer: A Comprehensive Review. Cancers (Basel). 2020;12(12):3730. doi: 10.3390/cancers12123730. PMID: 33322519; PMCID: PMC7763876

3. Sturgeon CM, Duffy MJ, Stenman UH, et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate colorectal, breast, and ovarian cancers. Clin Chem. 2008;54(12):11-79

4. The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer. American College of Obstetricians and Gynecologists. 2011. Committee Opinion Number 477

Method Description
Describes how the test is performed and provides a method-specific reference

The Roche Elecsys CA 125 II (cancer antigen 125) assay is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal CA 125-specific antibody and a monoclonal CA 125-specific antibody labeled with a ruthenium complex. CA 125 in the specimen reacts with both the biotinylated monoclonal CA 125-specific antibody (mouse) and the monoclonal CA 125-specific antibody (mouse) labeled with ruthenium, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of CA 125 in the patient specimen.(Package insert: Elecsys CA 125 II. Roche Diagnostics; V1.0, 09/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86304

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CA25 Cancer Ag 125 (CA 125), S 83082-8
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CA25 Cancer Ag 125 (CA 125), S 83082-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports