Analytical Validation of ThyroSPEC™ (Stewardson et al., Thyroid, 2023)
ThyroSPEC is a custom Agena probe multipanel using single nucleotide extension and MALDI-TOF analysis for the determination of SNVs, fusion transcripts, and limited gene expression data. This assay underwent analytical validation in a College of Physicians and Surgeons of Alberta accredited laboratory (Alberta Precision Laboratories) on 13 FFPE, 13 CytoLyt FNAC, 11 DNA/RNA direct smear/pre-extracted samples, and two commercial controls panels (SeraCare CTL DNA AF10% and Seracare Fusion CTL RNA).
| Analytical Sensitivity: | 96.8% |
| Analytical Specificity: | 99.9% |
| Accuracy: | 97% |
| Precision: | 98% |
| VAF LOD: | 5% |
Nucleic acid concentration sensitivity, the lowest amount of target nucleic acid that can be detected by the assay, is 0.1 ng/ul for DNA and 1.0 ng/ul for RNA.
Clinical Validation of ThyroSPEC™ (Stewardson et al., Thyroid, 2023)
ThyroSPEC underwent clinical validation on 64 AUS/FLUS and 33 FN/SFN consecutive CytoLyt FNAC with histologic diagnoses, data presented at the 2019 American Thyroid Association Annual Meeting (Stewardson et al., ATA, 2019).
For 26% pre-test risk of malignancy in the AUS/FLUS category:
| Sensitivity: | 55% |
| Specificity: | 88% |
| Positive Predictive Value (PPV): | 61% |
| Negative Predictive Value (NPV): | 85% |
For 43% pre-test risk of malignancy in the FN/SFN category:
| Sensitivity: | 38% |
| Specificity: | 75% |
| Positive Predictive Value (PPV): | 54% |
| Negative Predictive Value (NPV): | 62% |
The Paschke & Eszlinger Lab 