Diagnostic usefulness of the Risk of Ovarian Malignancy Algorithm using the electrochemiluminescence immunoassay for HE4 and the chemiluminescence microparticle immunoassay for CA125.

The present study aimed to investigate the usefulness of the Risk of Ovarian Malignancy Algorithm (ROMA) in the preoperative stratification of patients with ovarian tumors using a novel combination of laboratory tests. The study group (n=619) consisted of 354 premenopausal and 265 postmenopausal patients. The levels of carbohydrate antigen 125 (CA125) and human epididymis protein 4 (HE4) were determined, and ROMA calculations were performed for each pre- and postmenopausal patient. HE4 levels were determined using an electrochemiluminescence immunoassay, while CA125 levels were determined by a chemiluminescence microparticle immunoassay. A contingency table was applied to calculate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Receiver operating characteristic curves were also constructed, and areas under the curves (AUCs) were compared between the marker determinations and ROMA algorithms. In terms of distinguishing between ovarian cancer and benign disease, the sensitivity of ROMA was 88.3%, specificity was 88.2%, PPV was 75.3% and NPV was 94.9% among all patients. The respective parameters were 71.1, 90.1, 48.2 and 91.1% in premenopausal patients and 93.6, 82.9, 86.6 and 91.6% in postmenopausal patients. The AUC value for the ROMA algorithm was 0.926 for the ovarian cancer vs. benign groups in all patients, 0.813 in premenopausal patients and 0.939 in postmenopausal patients. The respective AUC values were 0.911, 0.879 and 0.934 for CA125; and 0.879, 0.783 and 0.889 for HE4. In this combination, the ROMA algorithm is characterized by an extremely high sensitivity of prediction of ovarian cancer in women with pelvic masses, and may constitute a precise tool with which to support the qualification of patients to appropriate surgical procedures. The ROMA may be useful in diagnosing ovarian endometrial changes in young patients.