Lee Eun-Gyeong, Han Jaihong, Lee Seeyoun, Kim Sung-Soo, Park Young-Min, Lee Dong-Eun, Kim Yumi, Noh Dong-Young, Jung So-Youn
Department of Surgery, Center of Breast Cancer, Research Institute and Hospital, National Cancer Center, Goyang 10408, Republic of Korea.
Manufacturing and Technology Division, Bertis Inc., Yongin 16954, Republic of Korea.
Cancers (Basel). 2025 Aug 29;17(17):2832. doi: 10.3390/cancers17172832.
: A newly developed nine-protein serum signature has been utilized to enhance the accuracy of an existing three-protein signature used as a blood-based diagnostic tool. This study used the new nine-protein serum signature to evaluate the clinical sensitivity and specificity of a medical device designed to test the clinical performance of an artificial intelligence algorithm. : A blood-based test using multiple reaction monitoring via mass spectrometry was performed to quantify nine proteins (APOC1, CHL1, FN1, VWF, PPBP, CLU, PRDX6, PRG4, and MMP9) in serum samples from 243 healthy controls and 222 patients with breast cancer. : Based on cutoff values determined by an artificial intelligence-based deep learning model, the sensitivity and specificity of the nine-protein signature in diagnosing breast cancer among all participants was 83.3% and 88.1%, respectively, whereas those of the three-protein signature were 71.6% and 85.3%, respectively. The assay yielded a positive predictive value of 86.5% for breast cancer and 13.6% for healthy controls, with corresponding negative predictive values of 14.7% and 85.3%, respectively. The accuracies of nine- and three-protein signatures were 85.8% (area under the receiver operating characteristic curve: 0.8526) and 77.0%, respectively. : The nine-protein signature may help detect breast cancer more accurately and effectively than the three-protein signature.
一种新开发的九蛋白血清标志物已被用于提高现有的作为血液诊断工具的三蛋白标志物的准确性。本研究使用新的九蛋白血清标志物来评估一种旨在测试人工智能算法临床性能的医疗设备的临床敏感性和特异性。:通过基于质谱的多反应监测进行血液检测,以定量来自243名健康对照和222名乳腺癌患者血清样本中的九种蛋白质(载脂蛋白C1、细胞粘附分子1、纤连蛋白1、血管性血友病因子、血小板碱性蛋白、簇集素、过氧化物还原酶6、蛋白聚糖4和基质金属蛋白酶9)。:基于由基于人工智能的深度学习模型确定的临界值,在所有参与者中,九蛋白标志物诊断乳腺癌的敏感性和特异性分别为83.3%和88.1%,而三蛋白标志物的敏感性和特异性分别为71.6%和85.3%。该检测对乳腺癌的阳性预测值为86.5%,对健康对照的阳性预测值为13.6%,相应的阴性预测值分别为14.7%和85.3%。九蛋白和三蛋白标志物的准确率分别为85.8%(受试者工作特征曲线下面积:0.8526)和77.0%。:与三蛋白标志物相比,九蛋白标志物可能有助于更准确、有效地检测乳腺癌。