Test Catalog

Test Id : ROMA

ROMA Score (Ovarian Malignancy Risk Algorithm), Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Risk assessment for finding an ovarian malignancy during surgery in women who present with an adnexal mass

 

The test is not intended as a screening or stand-alone diagnostic assay for ovarian cancer.

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
HE4R HE4,S Yes, Bill Only Yes
CA125 Cancer Ag 125 (CA 125), S Yes, Bill Only Yes
ROMA1 Risk Score, if premenopausal No Yes
ROMA2 Risk Score, if postmenopausal No Yes

Method Name
A short description of the method used to perform the test

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

ROMA Score

Aliases
Lists additional common names for a test, as an aid in searching

ROMA

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: Patients receiving therapy with high biotin doses (ie, >5 mg/day) should not have their specimen collected until at least 8 hours following the last biotin administration.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 84 days
Refrigerated 48 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Risk assessment for finding an ovarian malignancy during surgery in women who present with an adnexal mass

 

The test is not intended as a screening or stand-alone diagnostic assay for ovarian cancer.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Women with ovarian cancer symptoms and adnexal masses present primarily to gynecologists, primary care physicians, or general surgeons. Triage guidelines from the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists recommend referral of women with a pelvic mass at high risk for ovarian cancer to gynecologic oncologists. Specialized treatment improves patient outcomes resulting in fewer complications and better survival rates when compared to patients treated by surgeons less familiar with the management of ovarian cancer.

 

The risk of ovarian malignancy algorithm (ROMA) incorporates cancer antigen 125 (CA125), human epididymal protein 4 (HE4), and menopausal status to assign women that present with an adnexal mass into a high-risk or low-risk group for finding an ovarian malignancy. ROMA is indicated for women who meet the following criteria: older than age 18, presenting with an adnexal mass for which surgery is planned, and who have not yet been referred to an oncologist. ROMA must be interpreted in conjunction with clinical and radiological assessment.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Males: Not applicable

 

Females:

HUMAN EPIDIDYMIS PROTEIN 4< or =140 pmol/L

 

CANCER ANTIGEN 125 <46 U/mL

 

ROMA SCORE

Premenopausal: <1.14 (low risk)

Postmenopausal: <2.99 (low risk)

Interpretation
Provides information to assist in interpretation of the test results

In premenopausal women, a risk of ovarian malignancy algorithm (ROMA) value of 1.14 or greater indicates a high risk of finding epithelial ovarian cancer, whereas a ROMA value less than 1.14 indicates a low risk of finding epithelial ovarian cancer at surgery.

 

In postmenopausal women, a ROMA value of 2.99 or greater indicates a high risk of finding epithelial ovarian cancer, whereas a ROMA value less than 2.99 indicates a low risk of finding epithelial ovarian cancer at surgery.

 

The use of these cut-points provides a 75% specificity and sensitivity of 84% in patients with stage I-IV epithelial ovarian cancer.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The risk of ovarian malignancy algorithm (ROMA) test should not be used without an independent clinical/radiological evaluation and is not intended to determine whether a patient should proceed to surgery. A low-likelihood ROMA result in the setting of a positive initial cancer risk assessment should not preclude an oncology referral.

 

ROMA has not been validated for the following groups: women previously treated for malignancy, women currently being treated with chemotherapy, pregnant women, or women younger than age 18.

 

Serum markers are not specific for malignancy and values may vary by method. Values obtained with different assay methods cannot be used interchangeably.

 

In rare cases, interference due to extremely high titers of antibodies to specific reagents (human antimouse antibody or heterophile antibodies, streptavidin or ruthenium) can occur. The laboratory should be alerted if result does not correlate with the clinical presentation.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Moore RG, Jabre-Raughley M, Brown AK, et al: Comparison of a novel multiple marker assay vs the Risk of Malignancy Index for the prediction of epithelial ovarian cancer in patients with a pelvic mass. Am J Obstet Gynecol. 2010;203:228.e1-6

2. Karlsen MA, Sandhu N, Hogdall C, et al: Evaluation of HE4, CA125, risk of ovarian malignancy algorithm (ROMA) and risk of malignancy index (RMI) as diagnostic tools of epithelial ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2012;127(2):379-383

Method Description
Describes how the test is performed and provides a method-specific reference

Serum Elecsys human epididymal protein 4 (HE4) assay and the serum Elecsys cancer antigen 125 (CA 125) II assay results are used in the calculation. The instrument used is the Roche cobas.

 

The Roche Elecsys HE4 assay is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal HE4-specific antibody and a monoclonal HE4-specific antibody labeled with ruthenium complex. HE4 in the specimen reacts with both the biotinylated monoclonal HE4-specific antibody (mouse) and the monoclonal HE4-specific antibody (mouse) labeled with a ruthenium, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of HE4 in the patient specimen.(Package insert: Elecsys HE4 reagent, Roche Diagnostics, Indianapolis, IN., V 1.0, 05/2017)

 

The Roche Elecsys CA 125 II assay is a sandwich electrochemiluminescence immunoassay that employs biotinylated monoclonal CA125-specific antibody (mouse) and a monoclonal CA 125-specific antibody (mouse) labeled with ruthenium. CA125 in the specimen reacts with both antibodies to form a sandwich complex. Streptavidin-coated microparticles are added and the antibody sandwich complex binds to the microparticles through interaction of biotin and streptavidin. This mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, and unbound substances are removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of CA125 in the patient specimen.(Package insert: Elecsys CA 125 II reagent, Roche Diagnostics , Indianapolis, IN., V1.0, 05/2017)

 

Both HE4 and CA125 results are reported, along with a calculated Ovarian Malignancy Risk Score for both premenopausal and postmenopausal women.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86305-HE4, S

86304-Cancer Ag 125 (CA 125), S

LOINC® Information

Test Id Test Order Name Order LOINC Value
ROMA ROMA Score In Process
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports