Ovarian malignancy risk

Alphabetical Test listing

Ovarian malignancy risk-994

Test name:

Test number:

994

Excellian order number:

LAB994

Abbreviation:

MSO

Alternate names:

ROMA OVA-1 OVA1

Useful for:

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.

Patient preparation information:

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.

Specimen type:

Serum

Collection container:

Gold serum separator (SST) tube

Volume:

1.75 mL

Minimum volume:

1.0 mL
Submission of the minimum volume does not allow for repeat testing

Collection instructions:

Immediatley following collection, mix sample by gently inverting 5 times

Processing instructions:

Allow sample to clot for a minimum of 30 minutes
Spin within two (2) hours of sample collection

Transport container:

Gold serum separator (SST) tube

Alternate collection container:

Red serum vial/tube - 5 mL

Alternate processing instructions:

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

Alternate transport container:

Transfer vial/tube with cap - 12mL (LabCorp)

Transport and stability:

Refrigerated (preferred) - 14 days

Ambient - 5 days

Reason for rejection:

Gross hemolysis

Performing lab:

LabCorp Burlington (140045): R-NX

Days set up:

Mo - Fr

TAT:

4 days

Method:

Electrochemiluminescence Immunoassay (ECLIA)

Reference ranges:

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

Cautions:

Biotin supplement interference - see patient preparation

Preauthorization:

This test may require preauthorization from the insurance provider. Check the payer guidelines and, if needed, obtain the pre-authorization prior to sample collection.

CPT codes:

81500

Subject to medical necessity (Y/N):

Yes

LOINC code:

Result 10334-1

Other billing information:

Medical necessity

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medical billing request form along with the sample.

Complete and submit the form to notify us of the need for Allina Health Laboratory to bill insurance for Molecular testing performed
All information requested is required in order for your request to be completed

Molecular Medicare billing request

Date created:

05/22/2019

Revised date:

06/23/2023

Review date:

03/31/2022