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HelpOrder 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 |
|---|---|---|
| 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)
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
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86305-HE4, S
86304-Cancer Ag 125 (CA 125), S
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.