Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in thyroid cancer
Authors: Zhou Huimei , Wu Yutong , Liao Peng , Sun Chen , Ge Zhenjian , Chen Wenkang , Li Yingqi , Lin Shengjie , Zhang Pengwu , Wang Wuping , Chen Siwei , Li Xutai , Li Wei , Cui Yongyan , He Jinsong , Lai Yongqing 
Published: July 2024

Background

Thyroid tumor, as an endocrine tumor with increasing incidence, causes a heavy economic burden. Thyroid ultrasound is widely used for screening or diagnosis of thyroid tumors. However, false-positive thyroid ultrasound results can lead to misdiagnosis and wrong puncture biopsy, while false-negative thyroid ultrasound results can lead to missed diagnosis and delayed treatment. There is an urgent need to find a convenient, cost-effective and non-invasive diagnostic method to reduce the false-positive and false-negative rates of thyroid ultrasound. The aim of the present study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in thyroid cancer.

Patients and methods

843 subjects (malignant group, n=820; benign group, n=23) were finally included in this study. The remaining serum samples were collected and tested by YiDiXie ™ all-cancer detection kit. The sensitivity and specificity of YiDiXie™-SS were evaluated respectively.

Results

The sensitivity of YiDiXie™-SS was 98.5% (95% CI: 97.5% - 99.2%) and its specificity was 65.2% (95% CI: 44.9% - 81.2%). This means that YiDiXie ™ -SS has an extremely high sensitivity and relatively high specificity in thyroid tumors.YiDiXie™-HS has a sensitivity of 84.3% (95% CI: 81.6% - 86.6%) and a specificity of 87.0% (95% CI: 67.9% - 95.5%). This means that YiDiXie™-HS has high sensitivity and specificity in thyroid tumors.YiDiXie™-D has a sensitivity of 75.5% (95% CI: 72.4% - 78.3%) and a specificity of 95.7% (95% CI: 79.0% - 99.8%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in thyroid tumors.The sensitivity of YiDiXie™-SS in patients with positive thyroid ultrasound was 98.4% (95% CI: 97.3% - 99.1%) and the specificity was 64.3% (95% CI: 38.8% - 83.7%). This means that the application of YiDiXie ™ -SS reduced the false-positive thyroid ultrasound rate by 64.3% (95% CI: 38.8% - 83.7%) with essentially no increase in malignant tumor underdiagnosis.The sensitivity of YiDiXie™-HS in thyroid ultrasound-negative patients was 90.0% (95% CI: 79.9% - 95.3%) and the specificity 88.9% (95% CI: 56.9%). (95% CI: 56.5% - 99.4%). This means that the application of YiDiXie™-HS reduced the false negative rate of thyroid ultrasound by 90.0% (95% CI: 79.9% - 95.3%).YiDiXie ™-D has a sensitivity of 75.3% (95% CI: 72.1% - 78.2%) and a specificity of 92.9% (95% CI: 68.5% - 99.6%) in patients with positive thyroid ultrasound. This means that YiDiXie™-D reduces the rate of false-positive thyroid ultrasounds by 92.9% (95% CI: 68.5% - 99.6%). YiDiXie™-D has a sensitivity of 78.3% (95% CI: 66.4% - 86.9%) and a specificity of 100% (95% CI: 70.1% - 100%) in patients with negative thyroid ultrasounds. This means that YiDiXie™-D reduces the false-negative rate of thyroid ultrasound by 78.3% (95% CI: 66.4% - 86.9%) while maintaining high specificity.

Conclusion

YiDiXie™-SS has extremely high sensitivity and relatively high specificity in thyroid tumors.YiDiXie™-HS has high sensitivity and high specificity in thyroid tumors.YiDiXie ™ -D has relatively high sensitivity and extremely high specificity in thyroid tumors. YiDiXie™-SS significantly reduces thyroid ultrasound false-positive rates with essentially no increase in delayed treatment for thyroid cancer.YiDiXie ™ -HS significantly reduces thyroid ultrasound false-negative rates.YiDiXie™-D significantly reduces thyroid ultrasound false-positive rates or significantly reduces its false-negative rates while maintaining high specificity. YiDiXie™ tests have vital diagnostic value in thyroid cancer, and are expected to solve the problems of “high false-positive rate” and “high false-negative rate” of thyroid ultrasound.

Clinical trial number

ChiCTR2200066840.