Prospective Validation of ThyroSPEC Molecular Testing of Indeterminate Thyroid Nodule Cytology Following Diagnostic Pathway Optimization
Authors' conclusion
Molecular testing improves preoperative risk stratification but requires further stratification for intermediate-risk mutations. Incorporation of clinical factors (especially USMR) with molecular testing may increase the sensitivity for detection of malignancy. Introduction of molecular testing offers some clinical benefits even in a low resection rate setting, and directly influences surgical decision-making.
Study context
- Population
- Consecutive patients with cytologically indeterminate thyroid nodules (ITNs) in a centralized health care system after implementation of a reflexive molecular test
- Participants
- 615 consecutive patients
- Comparison
- ThyroSPEC molecular testing of ITN cytology; before vs after implementation of molecular testing
- Outcome
- Diagnostic accuracy of the molecular test
Methodological detailsconsecutive patients, centralized health care system, multivariable regression
- Consecutive patients
- Centralized health care system
- Multivariable regression
Performance
As reported in the abstract
Diagnostic accuracy in ITNs
| Test or model | NPV | PPV |
|---|---|---|
| Molecular test | 76-91% (CI 66-95%) | 46-65% (CI 37-75%) |
Molecular test
NPV76-91% (CI 66-95%)
PPV46-65% (CI 37-75%)
Further findings
Sensitivity by American Thyroid Association (ATA) ultrasound category
- Sensitivity, ATA intermediate-suspicion (highest)
- 80% (CI 63-92%)
- Sensitivity, ATA high-suspicion (lowest)
- 46% (CI 19-75%)
Impact of implementing molecular testing
- Diagnostic yield increased
- 14% (p = 0.2442)
- Repeat fine-needle aspiration (FNAs) decreased
- 24% (p = 0.05)
- Mutation the primary reason for surgery in resected, mutation-positive patients
- 76%
- Shorter wait for surgery with high-risk mutations
- 58% (p = 0.0001)
- Negative molecular test patients who underwent surgery
- 26%
Factors associated with malignancy (multivariable regression)
- Molecular testing and ultrasound malignancy risk (USMR) significantly associated with malignancy
Original publication
Prospective Validation of ThyroSPEC Molecular Testing of Indeterminate Thyroid Nodule Cytology Following Diagnostic Pathway Optimization. Thyroid. Published 17 October 2023. doi:10.
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