Useful For
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. The Elecsys CA 125 II assay is further indicated for serial measurement of CA 125 to aid in the management of cancer patients.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Method Name
Roche electrochemiluminescence immunoassay. The measured CA 125 value of a patient’s sample can vary depending on the testing procedure used. CA 125 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations. If there is a change in the CA 125 assay procedure used while monitoring therapy, then the CA 125 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.
Important Note
This assay should not be used as a cancer screening test, but should be used in conjunction with other clinical methods for monitoring ovarian cancer.
Aliases
CA 125; Cancer Antigen 125; Ovarian Cancer Antigen, CA 125
Specimen Required
One Lithium Heparin separator or one SST/gel tube
Specimen Minimum Volume
2.0 mL of blood
Specimen Stability Information
Centrifuged specimen stable for 5 days refrigerated
Special Instructions
Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration.
Performing Laboratory
As ordered. Turn around time four hours.
Reference Values
Less than or equal to 35 U/mL
Day(s) and Time(s) Performed
As ordered. Turn around time 4 hours.
Specimen Retention Time
72 hours