Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in liver cancer

Abstract

BackgroundLiver cancer is one of the cancers that consistently ranks among the top five cancers in terms of incidence and mortality in many countries. Enhanced CT is widely used in liver tumor diagnosis. However, false-positive enhanced CT results can lead to misdiagnosis, and patients will suffer unnecessary mental anguish, costly tests and surgeries, physical injuries, and even organ removal and loss of function. While false-negative results of enhanced CT will bring delayed treatment, and the patients will thus have to bear the adverse consequences of poor prognosis, high treatment costs, poor quality of life, and short survival period. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-positive rate of ultrasound and the false-negative and false-positive rates of enhanced CT for liver tumors. The purpose of this study is to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in liver cancer.Patients and methodsThis study finally included 217 subjects (the malignant group, n=185; the benign group, n=32). Remaining serum samples from the subjects were collected and tested using the YiDiXie™ all-cancer detection kit, which was applied to assess the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively.ResultsYiDiXie™-SS had a sensitivity of 99.2% (95% CI: 95.8% - 100%; 129/130) and a specificity of 66.7% (95% CI: 39.1% - 86.2%; 8/12) in hepatic enhanced CT positive patients. This means that the application of YiDiXie ™ -SS reduces the false positive rate of hepatic enhanced CT by 66.7% (95% CI: 39.1% - 86.2%; 8/12) with essentially no increase in malignancy leakage.The sensitivity of YiDiXie™-HS in hepatic enhanced CT-negative patients was 89.1% (95% CI: 78.2% - 94.9%; 49/55) and its specificity was 85.0% (95% CI: 64.0% - 94.8%; 17/20). This means that YiDiXie™-HS reduced the false-negative rate of enhanced CT by 89.1% (95% CI: 78.2% - 94.9%; 49/55). YiDiXie™-D had a sensitivity of 34.6% (95% CI: 27.0% - 43.1%; 45/130) and a specificity of 91.7% (95% CI: 64.6% - 99.6%; 11/12) in hepatic enhanced CT positive patients. This means that YiDiXie™-D reduces the false positive rate of enhanced CT by 91.7% (95% CI: 64.6% - 99.6%; 11/12).ConclusionYiDiXie™-SS has a significant effect on reducing the false-positive rate of hepatic enhanced CT, with no significant delay in malignancy treatment. YiDiXie ™-HS substantially reduces the false negative rate of hepatic enhanced CT. YiDiXie™-D substantially reduces the false positive rate of hepatic enhanced CT. The YiDiXie™ test has significant diagnostic value in liver tumors, and is expected to solve the problems of “high false-positive rate of enhanced CT” and “high false-negative rate of enhanced CT” in liver tumorsClinical trial numberChiCTR2200066840.