Evaluation of the diagnostic value of YiDiXie™-SS in thyroid ultrasound-positive patients

Abstract

BackgroundThyroid tumor, as an endocrine tumor with increasing incidence, causes a heavy economic burden. Ultrasound scanning is widely used for screening or preliminary diagnosis of thyroid tumors, but its large number of false-positive results brings unnecessary mental pain, expensive examination costs, physical injury and other adverse consequences. There is an urgent need to find a convenient, cost-effective and noninvasive method to reduce the false-positive rate of thyroid ultrasound. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS in thyroid ultrasound-positive patients.Patients and methods360 subjects (malignant group, n=342; benign group, n=18) 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.ResultsThe sensitivity of YiDiXie™-SS in the malignant group was 98.5%(95% CI: 96.6% - 99.4%; 337/342) with a false negative rate of 1.5%(95% CI: 0.6% - 3.4%; 5/342). The specificity of YiDiXie™-SS for the benign group was 66.7%(95% CI: 43.7% - 83.7%; 12/18), and the false positive rate was 33.3%(95% CI: 16.3% - 56.3%; 12/18). This means that YiDiXie™-SS reduces the false positive rate by 66.7%(95% CI: 43.7% - 83.7%; 12/18) with essentially no increase in malignancy leakage.ConclusionYiDiXie ™ -SS significantly reduces the false-positive rate of thyroid ultrasound-positive patients without increasing the number of under-diagnosed malignant tumors. YiDiXie ™ -SS has vital diagnostic value in thyroid ultrasound-positive patients, and is expected to solve the problem of “high false-positive rate of thyroid ultrasound”.Clinical trial numberChiCTR2200066840.