Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in lung cancer
Authors: Lin Shengjie , Li Xutai , Wang Wuping , Sun Chen , Ge Zhenjian , Chen Wenkang , Li Yingqi , Wu Yutong , Zhang Pengwu , Chen Siwei , Zhou Huimei , Li Wei , Chen Hua , Liu Jixian , Lai Yongqing 
Published: July 2024

Background

Lung cancer poses a serious threat to human health. Lung CT is widely used for lung tumor screening or initial diagnosis, while contrast-lung CT is extensively employed in lung tumor diagnosis. However, false-positive lung CT results can lead to misdiagnosis and incorrect surgery or treatment, while false-negative lung CT results can lead to missed diagnosis and delayed treatment. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-positive rate and false-positive rates of lung CT. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, in lung cancer.

Patients and methods

This study finally included 1250 subjects (the malignant group, n=1078; the benign group, n=172). 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.Results: YiDiXie™-SS has a sensitivity of 97.5% (96.4% - 98.3%) and its specificity is 66.9% (59.5% - 73.5%). This means that YiDiXie™-SS has very high sensitivity and high specificity in lung tumors.YiDiXie™-HS has a sensitivity of 85.3% (83.0% - 87.2%) and its specificity is 83.1% (76.8% - 88.0%). This means that YiDiXie™-HS has high sensitivity and high specificity in lung tumors.YiDiXie™-D has a sensitivity of 73.9% (71.2% - 76.5%) and its specificity is 92.4% (87.5% - 95.5%). This means that YiDiXie™-D has high sensitivity and very high specificity in lung tumors.YiDiXie™-SS has a sensitivity of 98.2% (95% CI: 96.8% - 99.0%) and a specificity of 66.0% (95% CI: 51.7% - 77.8%) in patients with CT-positive tumors. This means that the application of YiDiXie™-SS reduces the CT false-positive rate by 66.0% (95% CI: 51.7% - 77.8%) with essentially no increase in malignancy underdiagnosis. The sensitivity of YiDiXie™-HS in CT negative patients was 84.2% (95% CI: 80.6% - 87.2%) and its specificity was 82.4% (95% CI: 74.8% - 88.1%). This means that the application of YiDiXie ™ -HS reduces the false-negative lung CT rate by 84.2% (95% CI: 80.6% - 87.2%). YiDiXie™-D has a sensitivity of 73.7% (70.1% - 77.1%) and a specificity of 93.6% (82.8% - 97.8%) in CT-positive patients. This means that YiDiXie ™ -D reduces the rate of CT false positives by 93.6% (82.8% - 97.8%). YiDiXie™-D has a sensitivity of 74.2% (70.1% - 78.0%) and a specificity of 92.0% (85.9% - 95.6%) in patients with a negative CT. This means that YiDiXie™-D reduces the CT false-negative rate by 74.2% (70.1% - 78.0%) while maintaining high specificity.

Conclusion

YiDiXie™-SS provides extremely high sensitivity and high specificity in lung tumors. YiDiXie™-HS provides high sensitivity and high specificity in lung tumors. yiDiXie™-D provides high sensitivity and very high specificity in lung tumors. YiDiXie ™ -SS significantly reduces the rate of lung CT false positives with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS significantly reduces the false-negative rate of lung CT. YiDiXie™-D can significantly reduce the false-positive rate of lung CT or significantly reduce the false-negative rate while maintaining high specificity. the YiDiXie™ test has important diagnostic value in lung cancer and is expected to solve the problems of “too high false-positive rate” and “too high false-negative rate” of lung CT.

Clinical trial number

ChiCTR2200066840.