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Test Code ROMA ROMA Score (Ovarian Malignancy Risk Algorithm), Serum

Reporting Name

ROMA Score

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.


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

Serum

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

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 days

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.

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