评估 YiDiXie™-SS 对 PSA 阳性患者的诊断价值

Xutai Li, Zhenjian Ge, Qingshan Yang, Yutong Wu, Huimei Zhou, Chen Sun, Wenkang Chen, Yingqi Li, Shengjie Lin, Pengwu Zhang, Wuping Wang, Siwei Chen, Wei Li, Lingzhi Tao, Rong Huang, Liangchao Ni, Yongqing Lai
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摘要

背景:前列腺癌是最常见的恶性肿瘤之一,对人类健康构成严重威胁。前列腺特异性抗原(PSA)检测是前列腺癌筛查的常用方法,但其高假阳性率造成了不必要的精神痛苦、昂贵的检查费用、身体伤害和其他不良后果。因此,迫切需要找到一种方便、经济、无创的诊断方法来降低 PSA 的假阳性率。本研究旨在评估易迪协™-SS 对 PSA 阳性患者的诊断价值:研究最终纳入了465名PSA检测呈阳性的受试者(前列腺癌组,292人;良性前列腺增生组,173人)。收集受试者的剩余血清样本,并使用 YiDiXie™ 全癌检测试剂盒进行检测。结果表明,YiDiXie™-SS的灵敏度和特异性均优于BPH组:YiDiXie™-SS对恶性肿瘤组的灵敏度为100%(95% CI:98.7% - 100%;292/292),假阴性率为0(95% CI:0 - 1.3%;0/292)。YiDiXie™-SS 对良性组的特异性为 57.2% (95% CI: 49.8% - 64.4%; 99/173),假阳性率为 42.8% (95% CI: 35.6% - 50.2%; 74/173)。这意味着YiDiXie™-SS可将假阳性率降低57.2% (95% CI: 49.8% - 64.4%; 99/173),而恶性肿瘤漏诊率基本上没有增加。结论YiDiXie™-SS 可显著降低 PSA 阳性患者的假阳性率,同时不会增加诊断不足的恶性肿瘤数量。YiDiXie™-SS 对 PSA 阳性患者具有重要的诊断价值,有望解决 "PSA 假阳性率高 "的问题。临床试验编号ChiCTR2200066840.关键词前列腺癌 PSA 假阳性 YiDiXie™-SS
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the diagnostic value of YiDiXie™-SS in PSA-positive patients
Background: Prostate cancer is one of the most common malignant tumors and poses a substantial threat to human health. The PSA test is commonly used in prostate cancer screening, however its high rate of false-positive results causes unnecessary mental suffering, expensive examination costs, physical injury and other adverse consequences. Therefore, there is an urgent need to find a convenient, cost-effective and non-invasive diagnostic method to reduce the false-positive rate of PSA. This study aimed to assess the diagnostic value of YiDiXie™-SS in PSA-positive patients. Patients and methods: The study finally included 465 subjects with positive PSA test (prostate cancer group, n=292; BPH group, n=173). Remaining serum samples from the subjects were collected and tested with YiDiXie™ all-cancer detection kit. The sensitivity and specificity of YiDiXie™-SS were evaluated respectively. Results: The sensitivity of YiDiXie™-SS for the malignant group was 100% (95% CI: 98.7% - 100%; 292/292), with a false negative rate of 0 (95% CI: 0 - 1.3%; 0/292). The specificity of YiDiXie™-SS for the benign group was 57.2% (95% CI: 49.8% - 64.4%; 99/173), with a false positive rate of 42.8% (95% CI: 35.6% - 50.2%; 74/173). This means that YiDiXie™-SS reduces the false positive rate by 57.2% (95% CI: 49.8% - 64.4%; 99/173) with essentially no increase in malignancy leakage. Conclusion: YiDiXie™-SS significantly reduces the false-positive rate of PSA-positive patients without increasing the number of underdiagnosed malignant tumors. YiDiXie™-SS has vital diagnostic value in PSA-positive patients, and is expected to solve the problem of "high false-positive rate of PSA". Clinical trial number: ChiCTR2200066840. Key words: Prostate cancer, PSA, False-positive, YiDiXie™-SS
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