ROMA Score (Ovarian Malignancy Risk Algorithm), Serum
Use
The ROMA Score test is used for risk assessment of finding an ovarian malignancy during surgery in women presenting with an adnexal mass. It is not intended as a screening or stand-alone diagnostic assay for ovarian cancer. The test incorporates cancer antigen 125 (CA125), human epididymal protein 4 (HE4), and menopausal status to classify women into high-risk or low-risk categories for ovarian malignancy. Improved outcomes are associated with referral to gynecologic oncologists.
Special Instructions
Not provided.
Limitations
ROMA should not be used without an independent clinical/radiological evaluation and is not intended to determine surgical candidacy. It has not been validated for women previously treated for malignancy, those currently undergoing chemotherapy, pregnant women, or women younger than age 18. Repeat testing performance may vary due to antibodies or differing assay methods.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
Cancer Antigen 125
ProteinHuman Epididymis Protein 4
Protein
LOINC Codes
- 104551-7 - Ovarian malignancy (ROMA) panel SerPl
- 55180-4 - HE4 SerPl-sCnc
- 83082-8 - Cancer Ag125 SerPl IA-aCnc
- 69569-2 - ROMA score premen SerPl
- 69570-0 - ROMA score postmen SerPl
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
0.75 mL
Container
Plastic vial
Collection Instructions
Centrifuge and aliquot serum into a plastic vial.
Patient Preparation
For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements containing biotin (vitamin B7).
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 48 hours |
| Frozen | 84 days |