Ordering Recommendation

Assess cancer risk, particularly epithelial cell ovarian cancer, in pre- and postmenopausal women who present with an adnexal mass. Not intended as a screening, stand-alone, or tumor-monitoring assay. Tumor monitoring using HE4 and/or CA 125 should be ordered separately.

Mnemonic
ROMA
Methodology

Quantitative Electrochemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Serum Separator Tube (SST). Also acceptable: Green (Sodium or Lithium Heparin), Lavender (EDTA), or Pink (K2 EDTA).

Specimen Preparation

Allow specimen to clot completely at room temperature. Transfer 1.5 mL serum to an ARUP Standard Transport Tube. (Min: 1 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Hemolyzed specimens.

Remarks
Stability

Ambient: 5 hours; Refrigerated: 48 hours; Frozen: 4 months

Reference Interval

By Report

Interpretive Data

The Risk of Ovarian Malignancy Algorithm (ROMA) combines the results of HE4, CA125, and menopausal status into a numerical score. If the patient is premenopausal, then a ROMA score of less than 1.14 is consistent with a low likelihood of finding a malignancy on surgery. If the patient is postmenopausal, then a ROMA score of less than 2.99 is consistent with a low likelihood of finding a malignancy on surgery.

ROMA is intended as an aid in assessing whether a premenopausal or postmenopausal woman who presenting with an ovarian adnexal mass is at high or low likelihood of having malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and who has not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. ROMA is not intended as a screening or stand-alone or tumor-monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.

Testing for HE4 and CA125 was performed using Roche Cobas e602 electrochemiluminescent methods. Analyte results obtained with different test methods or kits cannot be used interchangeably.

Compliance Category

FDA

Note
Hotline History
N/A
CPT Codes

86304; 86305 (Alt code:81500 (MAAA))

Components
Component Test Code* Component Chart Name LOINC
2012619 ROMA, Premenopausal 69569-2
2012620 ROMA, Postmenopausal 69570-0
2012621 ROMA Cancer Antigen 125 83082-8
2012622 ROMA Human Epididymis Protein 4 55180-4
2013036 ROMA Interpretation 62364-5
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
Risk of Ovarian Malignancy Algorithm