Ovarian Malignancy Risk (ROMA)

Synonyms

  • LAB10853
  • OVARIAN MALIGNANCY RISK (ROMA)

Cerner Name

Ovarian Malignancy Risk (ROMA)

Clinical Info

The ROMA™ (Risk of Ovarian Malignancy Algorithm) calculation combines the results of the Roche Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score (Roche). The ROMA value is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.

Specimen Sources

Blood, Arterial Blood, Capillary Blood, Central Line Blood, Venous

Specimen Types

Blood

Specimen Volume

1.75 ml Serum (1.0 mL min-this volume does not allow for repeat testing)

Container

Gold Top Tube

Collection Instructions

Container/Tube: Gold Top or Red top tube
Specimen: 1.75 ml Serum (1.0 mL min-this volume does not allow for repeat testing)
Transport Temperature: Refrigerated  -Stable for 14 Days
 
Note: This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.

Transport Instructions

Refrigerated  -Stable for 14 Days

Specimen Stability

5 Days Room Temperature
14 Days Refrigerated

Methodology

Electrochemiluminescence immunoassay (ECLIA)

Days Performed

Performing Laboratories

LabCorp of America

CPT

81500

PDM

5904898

Results
Component Name Base Name Common Name External Name
CA 125 (LABCORP) CA125 CA 125 LABCORP Cancer Antigen (CA) 125
HE 4 HE4 HE 4 HE4
PREMENOPAUSAL ROMA PREMENROMA PREMENOPAUSAL ROMA Premenopausal ROMA
POSTMENOPAUSAL ROMA POSMENROMA POSTMENOPAUSAL ROMA Postmenopausal ROMA
ROMA COMMENT ROMACOM ROMA COMMENT ROMA Comment

Result Interpretation

Use of ROMA for stratification into low and high likelihood groups for finding malignancy on surgery
Using preoperatively collected serum samples, ROMA value were determined and the patients were stratified into a low or high likelihood group for finding malignancy on surgery.9 Samples were tested at three US testing sites. The following cut-off points were used in order to provide a specificity level of 75%:
Premenopausal women:
• ROMA score ≥1.14: high likelihood of finding malignancy
• ROMA score <1.14: low likelihood of finding malignancy
Postmenopausal women:
• ROMA score ≥2.99: high likelihood of finding malignancy
• ROMA score <2.99: low likelihood of finding malignancy
The reported results include both the likelihoods and associated ROMA scores for premenopausal and postmenopausal women on a scale of 0-10.

Forms
Molecular-send outs LAB10853 build edit