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ROMA™ (Risk of Ovarian Malignancy Algorithm) [91155]
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Test Code
ROMA
Alias/See Also
91155
CPT Codes
81500
Includes
CA125, HE4 Ovarian CA Monitoring, and Risk of Ovarian Malignancy calculation
Preferred Specimen
1 mL serum collected in a red-top tube (no gel)
Minimum Volume
0.5 mL
Instructions
Sample collected in red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour.
Transport Temperature
Frozen
Specimen Stability
Room temperature: 24 hours
Refrigerated: 72 hours
Frozen: 28 days
Refrigerated: 72 hours
Frozen: 28 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Moderate to gross hemolysis • Lipemia • Icteric • Presence of fibrin • Red blood cells • Other particulate matter • Obvious microbial contamination
Methodology
Calculation (CALC) • Chemiluminescent Microparticle Immunoassay (CMIA)
Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 3-5 days
Reference Range
| ROMA Premenopausal | <1.31 |
| ROMA Postmenopausal | <2.77 |
| CA125 | <35 U/mL |
| HE4, Ovarian CA Monitoring | |
| Female Premenopausal | ≤70 pmol/L |
| Female Postmenopausal | ≤140 pmol/L |
Clinical Significance
The risk of Ovarian Malignancy Algorithm (ROMA™) test is intended to aid in assessing the risk of ovarian cancer in women with a pelvic mass based on the patient's HE4 and CA125 levels, and their menopausal status. Women with ROMA™ levels above the cutoff have an increased risk of ovarian cancer. ROMA™ must be interpreted in conjunction with an independent clinical and radiological assessment.
The ROMA™ test is indicated for women who meet the following criteria:
over age 18; presence of an ovarian pelvic mass for which surgery is planned; and not yet referred to an oncologist.
The CA125 and HE4 tests are performed using the Abbott ARCHITECT i2000SR unit. The values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.
The test is not intended as a screening stand-alone diagnostic or tumor monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.
The ROMA value is the result of a computation based on the HE4 and CA125 values observed.
Reference:
1. Moore RG, et al. A novel multiple marker bioassay utilizing HE4 and CA 125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol 2009; 112:40-6.
The ROMA™ test is indicated for women who meet the following criteria:
over age 18; presence of an ovarian pelvic mass for which surgery is planned; and not yet referred to an oncologist.
The CA125 and HE4 tests are performed using the Abbott ARCHITECT i2000SR unit. The values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.
The test is not intended as a screening stand-alone diagnostic or tumor monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.
The ROMA value is the result of a computation based on the HE4 and CA125 values observed.
Reference:
1. Moore RG, et al. A novel multiple marker bioassay utilizing HE4 and CA 125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol 2009; 112:40-6.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
Last Updated: May 18, 2022
