Analytical Validation of a Telomerase Reverse Transcriptase (TERT) Promoter Mutation Assay
Authors' conclusion
The analytical robustness and reproducibility of the Afirma TERT test support its routine clinical use among thyroid nodules with indeterminate cytology that are Afirma Genomic Sequencing Classifier suspicious or among Bethesda V/VI nodules.
Study context
- Comparison
- Afirma TERT test vs reference primer pair
- Outcome
- Analytical validation of the Afirma TERT promoter mutation assay
Performance
As reported in the abstract
- Tolerant to variation in DNA input amount (ng)
- 7-13
- Limit of detection (LOD) of expected positive TERT promoter variants at 7 ng DNA input with >95% sensitivity (variant allele frequency (VAF))
- 5%
- NPA vs reference primer pair
- 100%
- PPA vs reference primer pair
- 100%
- Confirmation rate vs external next-generation sequencing-based reference assay in a non-Veracyte laboratory
- 100%
Original publication
Analytical Validation of a Telomerase Reverse Transcriptase (TERT) Promoter Mutation Assay. J Clin Endocrinol Metab. Published 5 March 2024. doi:10.
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