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HelpTest Code LAB8859 ROMA Score (Ovarian Malignancy Risk Algorithm), Serum
Additional Codes
ROMA
Secondary ID
62661Useful 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
Specimen Type
SerumSpecimen 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 Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 84 days | |
| Refrigerated | 48 hours |
On-campus collections: Tube to 99 or deliver to University Extension Hospital Room EH318
Submit in plastic vial, Frozen
Off-campus collections:
Centrifuge and aliquot within 2 hours.
Specimen to be stored/transported at Frozen temp.
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.
Method Description
Serum Elecsys human epididymal protein 4 (HE4) assay and the serum Elecsys cancer antigen 125 (CA 125) II assay results are used in the calculation. The instrument used is the Roche cobas.
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 reagent, Roche Diagnostics, Indianapolis, IN., V 1.0, 05/2017)
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 reagent, Roche Diagnostics , Indianapolis, IN., V1.0, 05/2017)
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 Friday
Report Available
1 to 3 daysSpecimen Retention Time
2 weeksPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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.