ROMA® (Risk of Ovarian Malignancy Algorithm)
Use
The Risk of Ovarian Malignancy Algorithm (ROMA®) combines serum levels of HE4 and CA‑125 along with menopausal status to produce a numerical score indicating likelihood of malignancy in women with an adnexal mass. It is intended to aid clinical assessment in conjunction with independent clinical and radiologic evaluation and is not designed for screening or as a standalone diagnostic tool. ROMA® is specifically intended for women scheduled for surgery and is not meant for general screening of ovarian cancer.
Special Instructions
Interference may occur in patients taking high-dose biotin (vitamin B7/B8); patients should discontinue biotin supplementation at least 72 hours prior to specimen collection.
Limitations
ROMA® should not be used as absolute proof of malignancy presence or absence, nor as a cancer screening tool. It is valid only in women undergoing planned surgical intervention and must always be interpreted with independent clinical evaluation.
Methodology
Immunoassay (ECLIA)
Biomarkers
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
Not provided
Minimum Volume
1.5 mL
Container
Gold Top, Serum Separator tube
Collection Instructions
Collect via venipuncture in gold top SST or lavender top (EDTA) tube. Centrifuge and transfer serum or EDTA plasma to aliquot tube.
Causes for Rejection
Hemolyzed specimens
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Room Temperature: 5 hours |
| Refrigerated | Refrigerated: 48 hours |
| Frozen | Frozen: 3 months |
Other tests from different labs that may be relevant