ROMA (Lumipulse G HE4 + Lumipulse G CA125II)
Lumipulse G ROMA Calculator Tool (CD-ROM):
Product # 803-000
Lumipulse G Risk of Ovarian Malignancy Algorithm (ROMA) is a qualitative serum and plasma (lithium heparin or dipotassium EDTA) test that combines the results of Lumipulse G HE4, Lumipulse G CA125II and menopausal status into a numerical score. Lumipulse G ROMA 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.
Lumipulse G ROMA 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. Lumipulse G ROMA 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.
Precaution: Lumipulse G ROMA should not be used without an independent clinical /radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of Lumipulse G ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.