Evaluation of Human Epididymis Protein 4, Risk of Ovarian Malignancy Algorithm, and Risk of Malignancy Index Efficiency for Ameliorating Sensitivity and Specificity for Differentiating Benign from Malignant Adnexal Masses

IF 0.9 Q3 MEDICINE, GENERAL & INTERNAL

Journal of Laboratory Physicians Pub Date : 2023-09-25 DOI:10.1055/s-0043-1775590

Sonia Chawla, Gitanjali Goyal, Seema Grover, Sarita Nibhoria, Jaswant Kaur

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Abstract

Abstract Background Inadequacy of effective sensitive and specific screening modalities results in late-stage diagnosis of ovarian cancer. Cancer Antigen-125 (CA-125) individually possesses limited specificity for differentiating adnexal masses. The present study aimed to evaluate the Human Epididymis Protein 4 (HE4), Risk of Ovarian Malignancy Algorithm (ROMA), and Risk of Malignancy Index (RMI) for ameliorating sensitivity and specificity for differentiating benign from malignant adnexal masses. Materials and Methods This study was conducted on 96 preoperative women with suspected adnexal mass (patients) and 48 healthy females without adnexal mass (controls) for the duration of 2 years. Both study participants were divided into two groups, pre- and postmenopausal. CA-125 and HE4 were done using commercially available kits. ROMA% and RMI were calculated. We validated their performances using histopathology as the gold standard. The statistical analysis was done using SPSS 21, Kruskal–Wallis, and Tukey's tests. The best cutoff points to best values of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were also evaluated. Results For differentiating benign from malignant masses in the premenopausal group, the sensitivity, specificity, PPV, NPV, and area under the curve (AUC) were 93.7%, 78.3%, 65.2%, 96.6%, 0.892 for CA-125; 87.5%, 83.7%, 70%, 93.9%, 0.926 for HE4; 93.7%, 70.2%, 57.6%, 96.2%, 0.927 for ROMA; and 68.7%, 86.4%, 68.7%, 86.5%, 0.916 for RMI. While in the postmenopausal group, the sensitivity, specificity, PPV, NPV, and AUC were 92.3%, 76.4%, 85.7%, 86.6%, 0.907 for CA-125; 78.5%, 94%, 95.6%, 80%, 0.955 for HE4; 92.3%, 94.1%, 96%, 88.8%, 0.968 for ROMA; and 88.4%, 88.2%, 92%, 83.3%, 0.943 for RMI. Conclusion For differentiating benign from malignant masses more specifically in women with a suspected adnexal mass, ROMA and HE4 appear to be more effective than CA-125.

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评估人附睾蛋白4、卵巢恶性肿瘤风险算法和恶性肿瘤风险指数效率，以提高区分良性和恶性附件肿块的敏感性和特异性

背景缺乏有效、敏感和特异的筛查方式导致卵巢癌的晚期诊断。癌抗原-125 (CA-125)单独对鉴别附件肿块具有有限的特异性。本研究旨在评估人类附睾蛋白4 (HE4)、卵巢恶性肿瘤风险算法(ROMA)和恶性肿瘤风险指数(RMI)在区分良性和恶性附件肿块方面的敏感性和特异性。材料与方法本研究对96例术前疑似附件肿块的女性(患者)和48例无附件肿块的健康女性(对照组)进行为期2年的研究。两项研究的参与者都被分为两组，绝经前和绝经后。CA-125和HE4使用市售试剂盒进行检测。计算ROMA%和RMI。我们用组织病理学作为金标准来验证他们的表现。采用SPSS 21、Kruskal-Wallis和Tukey检验进行统计分析。并对敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)的最佳临界值进行了评价。结果CA-125鉴别绝经前组肿块良恶性的敏感性、特异性、PPV、NPV、曲线下面积(AUC)分别为93.7%、78.3%、65.2%、96.6%、0.892;HE4为87.5%、83.7%、70%、93.9%、0.926;罗姆人93.7%、70.2%、57.6%、96.2%、0.927;RMI为68.7%、86.4%、68.7%、86.5%、0.916。而在绝经后组，CA-125的敏感性、特异性、PPV、NPV和AUC分别为92.3%、76.4%、85.7%、86.6%、0.907;HE4分别为78.5%、94%、95.6%、80%、0.955;罗姆人92.3%、94.1%、96%、88.8%、0.968;RMI为88.4%、88.2%、92%、83.3%、0.943。结论在疑似附件肿块的女性中，ROMA和HE4比CA-125更有效地鉴别肿块的良恶性。

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Journal of Laboratory Physicians MEDICINE, GENERAL & INTERNAL-

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31 weeks