Ovarian malignancy risk-994
Test 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. ROMA Calculation is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned and not yet referred to an oncologist. ROMA values must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
Specimen
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.
Submission of the minimum volume does not allow for repeat testing
Immediatley following collection, mix sample by gently inverting 5 times
- Allow sample to clot for a minimum of 30 minutes
- Spin within two (2) hours of sample collection
Gold serum separator (SST) tube
- Allow sample to clot
- Spin
- Transfer serum to a Transfer vial/tube with cap - 12mL (LabCorp) labelled as "serum" within two (2) hours of sample collection
Molecular Medicare Billing Request
Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.
Refrigerated (preferred) - 14 days
Ambient - 5 days
- Gross hemolysis
Performance
Electrochemiluminescence Immunoassay (ECLIA)
Clinical and Interpretive info
Cancer Antigen (CA) 125:
0.0 - 38.1 01 U/mL
HE4:
0.0 - 61.2 01 pmol/L
ROMA score:
Premenopausal women:
≥1.14: high likelihood of finding malignancy
<1.14: low likelihood of finding malignancy
Postmenopausal women:
≥2.99: high likelihood of finding malignancy
<2.99: low likelihood of finding malignancy
Billing
Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.