Background Thyroid 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 methods 360 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.

Results The 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.

Conclusion YiDiXie ™ -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 number ChiCTR2200066840.

The authors have declared no competing interest.

ChiCTR2200066840

This work was supported by Shenzhen High-level Hospital Construction Fund, Clinical Research Project of Peking University Shenzhen Hospital (LCYJ2020002, LCYJ2020015, LCYJ2020020, LCYJ2017001).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee of Peking University Shenzhen Hospital gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

All data produced in the present study are contained in the manuscript.