Ovarian Malignancy Risk (ROMA®)
Also known as: ROMA®
Use
The ROMA™ (Risk of Ovarian Malignancy Algorithm) calculation combines the results of the Roche Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score (Roche). The ROMA value is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA Calculation is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA values must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
Special Instructions
This test may exhibit interference when the sample is collected from a person consuming a high dose of biotin. Patients should stop biotin consumption at least 72 hours prior to sample collection.
Limitations
ROMA cannot be used as absolute evidence of malignant disease presence or absence. It is not a cancer screening test and has only been validated for women undergoing surgical intervention. ROMA should not be used without an independent clinical evaluation, and it is not intended to determine surgical decisions. A low ROMA result should not preclude oncology referral in the presence of a positive cancer risk assessment. ROMA is invalid for women previously treated for malignancy, those on chemotherapy, pregnant women, and women under 18.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 10334-1
- 55180-4
- 69569-2
- 69570-0
- 77202-0
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.75 mL
Minimum Volume
1 mL
Container
Red-top tube or gel-barrier tube
Collection Instructions
If a red-top tube is used, transfer separated serum to a plastic transport tube.
Patient Preparation
Patients should stop biotin consumption at least 72 hours prior to sample collection.
Storage Instructions
Refrigerate; stable for 5 days at room temperature or 14 days refrigerated.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 5 days |
| Refrigerated | 14 days |