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HelpTest Code ROMA ROMA Score (Ovarian Malignancy Risk Algorithm), Serum
Useful For
Risk assessment for finding an ovarian malignancy during surgery in women who present with an adnexal mass
The test is not intended as a screening or stand-alone diagnostic assay for ovarian cancer.
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HE4R | HE4,S | Yes, (Order HE4) | Yes |
| CA125 | Cancer Ag 125 (CA 125), S | Yes, (Order CA25) | Yes |
| ROMA1 | Risk Score, if premenopausal | No | Yes |
| ROMA2 | Risk Score, if postmenopausal | No | Yes |
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Reporting Name
ROMA ScoreSpecimen Type
SerumSpecimen Required
Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 84 days | |
| Refrigerated | 48 hours |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
Clinical Information
Women with ovarian cancer symptoms and adnexal masses present primarily to gynecologists, primary care physicians, or general surgeons. Triage guidelines from the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists recommend referral of women with a pelvic mass at high risk for ovarian cancer to gynecologic oncologists. Specialized treatment improves patient outcomes resulting in fewer complications and better survival rates when compared to patients treated by surgeons less familiar with the management of ovarian cancer.
The risk of ovarian malignancy algorithm (ROMA) incorporates cancer antigen 125 (CA125), human epididymal protein 4 (HE4), and menopausal status to assign women that present with an adnexal mass into a high-risk or low-risk group for finding an ovarian malignancy. ROMA is indicated for women who meet the following criteria: older than age 18, presenting with an adnexal mass for which surgery is planned, and who have not yet been referred to an oncologist. ROMA must be interpreted in conjunction with clinical and radiological assessment.
Reference Values
Males: Not applicable
Females:
HUMAN EPIDIDYMIS PROTEIN 4≤140 pmol/L
CANCER ANTIGEN 125 <46 U/mL
ROMA SCORE
Premenopausal: <1.14 (low risk)
Postmenopausal: <2.99 (low risk)
Interpretation
In premenopausal women, a risk of ovarian malignancy algorithm (ROMA) value of 1.14 or greater indicates a high risk of finding epithelial ovarian cancer, whereas a ROMA value less than 1.14 indicates a low risk of finding epithelial ovarian cancer at surgery.
In postmenopausal women, a ROMA value of 2.99 or greater indicates a high risk of finding epithelial ovarian cancer, whereas a ROMA value less than 2.99 indicates a low risk of finding epithelial ovarian cancer at surgery.
The use of these cut-points provides a 75% specificity and sensitivity of 84% in patients with stage I-IV epithelial ovarian cancer.
Cautions
The risk of ovarian malignancy algorithm (ROMA) test should not be used without an independent clinical/radiological evaluation and is not intended to determine whether a patient should proceed to surgery. A low-likelihood ROMA result in the setting of a positive initial cancer risk assessment should not preclude an oncology referral.
ROMA has not been validated for the following groups: women previously treated for malignancy, women currently being treated with chemotherapy, pregnant women, or women younger than age 18.
Serum markers are not specific for malignancy and values may vary by method. Values obtained with different assay methods cannot be used interchangeably.
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium can rarely occur and may also interfere in this assay. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Method Description
Serum Elecsys HE4 (human epididymal protein 4) assay and CA 125 II (cancer antigen 125) assay results are used in the calculation.
The Roche Elecsys HE4 assay is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal HE4-specific antibody and a monoclonal HE4-specific antibody labeled with ruthenium complex. HE4 in the specimen reacts with both the biotinylated monoclonal HE4-specific antibody (mouse) and the monoclonal HE4-specific antibody (mouse) labeled with a ruthenium, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of HE4 in the patient specimen.(Package insert: Elecsys HE4. Roche Diagnostics; V 3.0, 06/2024)
The Roche Elecsys CA 125 II assay is a sandwich electrochemiluminescence immunoassay that employs biotinylated monoclonal CA125-specific antibody (mouse) and a monoclonal CA 125-specific antibody (mouse) labeled with ruthenium. CA125 in the specimen reacts with both antibodies to form a sandwich complex. Streptavidin-coated microparticles are added and the antibody sandwich complex binds to the microparticles through interaction of biotin and streptavidin. This mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, and unbound substances are removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of CA125 in the patient specimen.(Package insert: Elecsys CA 125 II, Roche Diagnostics; V 2.0, 07/2024)
Both HE4 and CA125 results are reported, along with a calculated Ovarian Malignancy Risk Score for both premenopausal and postmenopausal women.
Day(s) Performed
Monday through Saturday
Report Available
1 to 3 daysSpecimen Retention Time
2 weeksPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86305-HE4, S
86304-Cancer Ag 125 (CA 125), S
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ROMA | ROMA Score | 104551-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HE4R | HE4,S | 55180-4 |
| CA125 | Cancer Ag 125 (CA 125), S | 83082-8 |
| ROMA1 | Risk Score, if premenopausal | 69569-2 |
| ROMA2 | Risk Score, if postmenopausal | 69570-0 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.