Ann Lab Med 2019; 39(3): 252-262
Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea
Haeil Park, M.D.1, Jae Eun Shin, M.D.2, Dae Woo Lee, M.D.2, Min Jeong Kim, M.D.2, and Hae Nam Lee, M.D.2
Departments of 1Laboratory Medicine and 2Obstetrics and Gynecology, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
Corresponding author: Hae Nam Lee, M.D.
Department of Obstetrics and Gynecology, Bucheon St. Mary's Hospital, The Catholic University of Korea, 327 Sosa-ro, Wonmi-gu, Bucheon 14647, Korea
Tel: +82-32-340-7083
Fax: +82-32-340-2255
Received: May 11, 2018; Revised: August 2, 2018; Accepted: November 7, 2018; Published online: May 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

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Background: The risk of ovarian malignancy algorithm (ROMA) is used for assessing ovarian cancer risk in women with a pelvic mass. Its diagnostic accuracy is variable. We investigated whether the clinically acceptable minimal sensitivity of >80.0% could be obtained with the suggested cutoff of 7.4%/25.3% for pre/postmenopausal women and with adjusted cutoffs set to a specificity of ≥75.0% or a sensitivity of 95.0%, in a hospital with a lower ovarian cancer (OC) prevalence than previously reported.
Methods: ROMA scores were calculated from measurements of human epididymis protein 4 and cancer antigen 125 in blood specimens from 443 patients with a pelvic mass. The ROMA-based risk group was compared against biopsy (N=309) or clinical follow-up with imaging (N=134) results. The ROMA sensitivity and specificity for predicting epithelial OC (EOC) and borderline ovarian tumor (BOT) were calculated for the suggested and adjusted cutoff values.
Results: When targeting BOT and EOC, the prevalence was 7.4% and sensitivity and specificity at the suggested cutoff were 63.6% and 90.7%, respectively. Sensitivity was 81.8% at the 4.65%/13.71% cutoff set to a specificity of 75.0%. When targeting only EOC, the prevalence was 4.1% and sensitivity and specificity at the suggested cutoff were 77.8% and 89.4%, respectively. Sensitivity was 88.9% at the 4.78%/14.35% cutoff set to a specificity of 75.0%.
Conclusions: The sensitivity of ROMA was lower than expected when using the suggested cutoff. When using the adjusted cutoff, its sensitivity reached 80.0%.
Keywords: Borderline ovarian tumor, Epithelial ovarian cancer, Risk of Ovarian Malignancy Algorithm, Sensitivity, Specificity, Prevalence

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