Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in prostate cancer
Authors: Li Xutai , Ge Zhenjian , Yang Qingshan , Sun Chen , Chen Wenkang , Li Yingqi , Lin Shengjie , Zhang Pengwu , Wang Wuping , Chen Siwei , Wu Yutong , Zhou Huimei , Li Wei , Huang Rong , Ni Liangchao , Lai Yongqing 
Published: June 2024

BackgroundProstate cancer is one of the most common malignant tumors and poses a substantial threat to human health. PSA or enhanced MRI is widely used in prostate cancer screening or diagnosis. However, false-positive PSA or enhanced MRI results can lead to misdiagnosis and incorrect puncture biopsy, while false-negative PSA or enhanced MRI results can lead to missed diagnosis and delayed treatment. There is an urgent need to find convenient, economical and non-invasive diagnostic methods to reduce the PSA or enhanced MRI false-negative and false-positive rates. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in prostate cancer.Patients and methodsThe study finally included 464 subjects with positive PSA test (prostate cancer group, n=292; BPH group, n=172). Remaining serum samples from the subjects were collected and tested with YiDiXie™ all-cancer detection kit. The sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D were evaluated respectively.ResultsThe sensitivity of YiDiXie™-SS was 100% (95% CI: 98.7% - 100%) and its specificity was 60.5% (95% CI: 53.0% - 67.5%). This means that YiDiXie™-SS has an extremely high sensitivity and relatively high specificity in prostate tumors.YiDiXie™-HS has a sensitivity of 93.8% (95% CI: 90.5% - 96.1%) and a specificity of 86.0% (95% CI: 80.1% - 90.4%). This means that YiDiXie™ -HS has high sensitivity and specificity in prostate tumors.YiDiXie™-D has a sensitivity of 80.8% (95% CI: 75.9% - 84.9%) and a specificity of 93.0% (95% CI: 88.2% - 96.0%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in prostate tumors.YiDiXie™-SS had a sensitivity of 100% (95% CI: 98.6% - 100%), 100% (95% CI: 97.6% - 100%) and specificity of 57.7% (95% CI: 49.8% - 65.2%), 59.6% (95% CI. 49.5% - 68.9%). This means that the application of YiDiXie™-SS reduced the false positive rate of PSA and enhanced MRI by 57.7% (95% CI: 49.8% - 65.2%), 59.6% (95% CI: 49.5% - 68.9%), respectively, with essentially no increase in the underdiagnosis of malignant tumors.YiDiXie™-HS had a sensitivity of 92.3% (95% CI: 66.7% - 99.6%), 90.2% (95% CI: 79.0% - 95.7%), and specificity of 81.3% (95% CI: 57.0% - 93.4%), 83.3% (95% CI : 55.2% - 97.0%),respectively. This means that the application of YiDiXie™-HS reduced the false-negative rate of PSA and enhanced MRI by 92.3% (95% CI: 66.7% - 99.6%), 90.2% (95% CI: 79.0% - 95.7%), respectively.The sensitivity of YiDiXie™-D in PSA and enhanced MRI positive patients was 81.0% (95% CI: 76.0% - 85.2%), 83.6% (95% CI: 77.1% - 88.6%), respectively, and its specificity was 92.9% (95% CI: 87.8% - 96.0%), 92.6% (95% CI : 85.4% - 96.3%), respectively. This means that YiDiXie™-D reduced PSA and enhanced MRI false positive rates by 92.9% (95% CI: 87.8% - 96.0%), 92.6% (95% CI: 85.4% - 96.3%), respectively.YiDiXie™-D had a sensitivity of 76.9% (95% CI: 49.7% - 91.8%) and 76.5% (95% CI: 63.2% - 86.0%) in PSA- and enhanced MRI-negative patients, respectively, and its specificity was 93.8% (95% CI: 71.7% - 99.7%) and 83.3% (95% CI : 55.2% - 97.0%), respectively. This means that YiDiXie™-D reduced PSA and enhanced MRI false-negative rates by 76.9% (95% CI: 49.7% - 91.8%) and 76.5% (95% CI: 63.2% - 86.0%), respectively, while maintaining a high specificity..ConclusionYiDiXie™-SS has very high sensitivity and relatively high specificity in prostate tumors.YiDiXie™-HS has high sensitivity and high specificity in prostate tumors.YiDiXie ™ -D has relatively high sensitivity and very high specificity in prostate tumors. YiDiXie ™-SS significantly reduces the rate of PSA or enhanced MRI false positives with essentially no increase in delayed treatment for prostate cancer.YiDiXie™-HS significantly reduces the rate of PSA or enhanced MRI false negatives.YiDiXie™-D significantly reduces the rate of PSA or enhanced MRI false positives or significantly reduces the rate of false negatives thereof while maintaining a high level of specificity. YiDiXie™ tests can play an important role in prostate cancer, and are expected to solve the problem of “high false-positive rate” and “high false-negative rate” of PSA or enhanced MRI.Clinical trial numberChiCTR2200066840.