Sign in →

Order 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

Reporting Name

ROMA Score

Specimen Type

Serum


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 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)

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

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.