Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea

• Published in: Annals of laboratory medicine Vol. 39; no. 3; pp. 252 - 262
• Main Authors: Park, Haeil, Shin, Jae Eun, Lee, Dae Woo, Kim, Min Jeong, Lee, Hae Nam
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society for Laboratory Medicine 01.05.2019; 대한진단검사의학회
• Subjects: Adult; Algorithms; Area Under Curve; CA-125 Antigen - blood; Female; Humans; Menopause; Middle Aged; Original; Ovarian Neoplasms - diagnosis; Ovarian Neoplasms - epidemiology; Prevalence; Proteins - analysis; Republic of Korea - epidemiology; ROC Curve; Sensitivity and Specificity; 병리학; Republic of Korea; Sensitivity; Specificity; Prevalence; Borderline ovarian tumor; Epithelial ovarian cancer; Risk of Ovarian Malignancy Algorithm
• ISSN: 2234-3806; 2234-3814
• DOI: 10.3343/alm.2019.39.3.252

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. 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. 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%. The sensitivity of ROMA was lower than expected when using the suggested cutoff. When using the adjusted cutoff, its sensitivity reached 80.0%.