Affiliation:
1. Division of Endocrinology, Diabetes and Metabolism, The Ohio State University and Arthur G. James Cancer Center , Columbus, OH 43210 , USA
2. Division of Metabolism, Endocrinology, and Nutrition, University of Washington , Seattle, WA 98105 , USA
3. Center of Biostatistics and Bioinformatics, The Ohio State University , Columbus, OH 43210 , USA
Abstract
Abstract
Background
Cytologically indeterminate thyroid nodules (ITN) pose a management challenge. Here we analyze if adding ultrasound characteristics to Afirma Genome Sequence Classifier (GSC) results increases GSC diagnostic performance.
Methods
We retrospectively analyzed 237 GSC-tested Bethesda III/IV ITNs between July 2017 and December 2019 and classified them by American Thyroid Association (ATA) and the Thyroid Imaging Reporting and Data System (TIRADS) of the American College of Radiology.
Results
The benign call rate was higher in Bethesda III ITNs with TIRADS <5 vs TIRADS 5 (89% vs 68%. P = .015). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of GSC in ATA high-risk Bethesda III ITNs vs lower were 100% vs 80% (P = 1), 89.5% vs 91.5% (P = .67), 66.7% vs 25% (P = .13), and 100% vs 99.2% (P = 1), respectively, and for TIRADS 5 vs <5 were 100% vs 80% (P = 1), 88.2% vs 91.4% (P = .65), 71.4% vs 23.5% (P = .06), and 100% vs 99.3% (P = 1). The sensitivity, specificity, PPV, and NPV of GSC in high-risk ATA Bethesda IV ITNs vs lower were 66.7% vs 100% (P = .42), 83.3% vs 85.7% (P = 1), 66.7% vs 64.3% (P = 1), and 83.3% vs 100% (P = .3), respectively, and for TIRADS 5 vs <5 were 66.7% vs 90% (P = .42), 88.9% vs 83.8% (P = 1), 66.7% vs 60% (P = 1), and 88.9% vs 96.9% (P = .39).
Conclusion
Sensitivity, specificity, NPV, and PPV of GSC were not significantly different in ATA high-risk and TIRADS 5 ITNs compared to ATA < high-risk and TIRADS 1-4 ITNs.