Assess cancer risk, particularly epithelial cell ovarian cancer, in pre- and postmenopausal women who present with an adnexal mass. Not intended as a screening, stand-alone, or tumor-monitoring assay. Tumor monitoring using HE4 and/or CA 125 should be ordered separately.
Quantitative Electrochemiluminescent Immunoassay
Within 24 hours
Serum Separator Tube (SST). Also acceptable: Green (Sodium or Lithium Heparin), Lavender (EDTA), or Pink (K2 EDTA).
Allow specimen to clot completely at room temperature. Transfer 1.5 mL serum to an ARUP Standard Transport Tube. (Min: 1 mL)
Ambient: 5 hours; Refrigerated: 48 hours; Frozen: 4 months
The Risk of Ovarian Malignancy Algorithm (ROMA) combines the results of HE4, CA125, and menopausal status into a numerical score. If the patient is premenopausal, then a ROMA score of less than 1.14 is consistent with a low likelihood of finding a malignancy on surgery. If the patient is postmenopausal, then a ROMA score of less than 2.99 is consistent with a low likelihood of finding a malignancy on surgery.
ROMA is intended as an aid in assessing whether a premenopausal or postmenopausal woman who presenting with an ovarian adnexal mass is at high or low likelihood of having malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and who has not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. ROMA is not intended as a screening or stand-alone or tumor-monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.
Testing for HE4 and CA125 was performed using Roche Cobas e602 electrochemiluminescent methods. Analyte results obtained with different test methods or kits cannot be used interchangeably.
No compliance statements are in use for this test.
86304; 86305 (Alt code:81500 (MAAA))
|Component Test Code*||Component Chart Name||LOINC|
|2012621||ROMA Cancer Antigen 125||83082-8|
|2012622||ROMA Human Epididymis Protein 4||55180-4|