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Risk of Ovarian Malignancy Algorithm
2012618
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
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
ARUP Consult®
Disease Topics
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.

Note
Hotline History
View Hotline History
CPT Code(s)
86304; 86305 (Alt code:81500 (MAAA))
Components
Component Test Code*Component Chart NameLOINC
2012619ROMA, Premenopausal69569-2
2012620ROMA, Postmenopausal69570-0
2012621ROMA Cancer Antigen 12583082-8
2012622ROMA Human Epididymis Protein 455180-4
2013036ROMA Interpretation62364-5
* 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