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