Test Code ROMA ROMA Score (Ovarian Malignancy Risk Algorithm), Serum
Reporting Name
ROMA ScorePerforming Laboratory
Mayo Clinic Laboratories in RochesterUseful 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.
Method Name
Specimen Required
Patient Preparation: Patients receiving therapy with high biotin doses (ie, >5 mg/day) should not have their specimen collected until at least 8 hours after the last biotin administration.
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 Type
SerumSpecimen 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 |
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.
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysTest 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.
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 |