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| Organization: | Alberta Precision Laboratories | ||||||||
| Message Alert: | PLEASE NOTE: This Test Directory is in an interim state and due to changes pertaining to the DynaLIFE transition, performing site for routing has not been updated. Please refer to Laboratory Information System for appropriate routing. | ||||||||
| Test Name/Synonym: | Thyroid Nodule Mutation Analysis, Fine-Needle Aspirate (Synonyms: ThyroSPEC, Thyroid Carcinoma Mutation Analysis) | ||||||||
| Clinical Indications: | Diagnostic / prognostic biomarker testing to assess risk of malignancy for indeterminate thyroid fine-needle aspiration (FNA) cytology specimens (Bethesda III AUS/FLUS, Bethesda IV FN/SFN) | ||||||||
| Test Includes: | DNA testing is performed to detect hotspot single nucleotide variants (SNVs) and insertion/deletion mutations (indels) in 17 genes: AKT1, BRAF, CTNNB1, DICER1, EGFR, EIF1AX, EZH1, HRAS, IDH1, KRAS, NRAS, PIK3CA, RET, SPOP, TERT, TP53, TSHR. RNA testing is performed to detect selected recurrent fusions involving 9 genes: ALK, BRAF, MAML2, NTRK1, NTRK3, PPARG, PRKAB1, RET, THADA. Note that this assay detects limited fusion partners and breakpoints and cannot detect a significant proportion of kinase fusions (including RET and NTRK fusions) that occur in thyroid carcinoma. | ||||||||
| LABID (Connect Care): | LAB4856 | ||||||||
| Specimen Type: | Cytology sample in PreservCyt® and/or CytoLyt® (preferred) Paraffin Embedded Tissue (less preferred) | ||||||||
| Specimen Source: | Thyroid | ||||||||
| Primary Container: | See Specimen Collection Requirements | ||||||||
| Alternate Containers: | Cytology sample in PreservCyt® Cytology sample in CytoLyt® | ||||||||
| Specimen Collection Requirements: | Cytology sample:
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| Test Resources: | Submit request using the applicable requisition or Connect Care online order entry:
Please ensure all required information, including patient's clinical history/indication, is provided on the requisition. | ||||||||
| Stability and Storage: | Room temperature: paraffin-embedded tissue blocks and slides
Refrigerated: cytology specimens up to 3 days | ||||||||
| Processing: | Keep specimens at appropriate storage temperature until ready to transport. | ||||||||
| Transportation: | Transport specimen at room temperature. Specimen must not freeze in transit. Transport to Pathology Department at Foothills Medical Center. | ||||||||
| Method: | PCR followed by mass spectrometry or sequence analysis | ||||||||
| Method and Interpretation of Results: | DNA and RNA: Analysis for point mutations is performed after PCR amplification using a single base extension technique (Agena iPLEX) and mass spectrometry on the MassArray instrument. This multiplexed assay detects hotspot mutations and fusions in the above listed genes. Analysis is limited to tumor tissue and, therefore, this test is unable to distinguish between somatic (acquired) and germline (inherited) variants. | ||||||||
| Routine Turn Around Time: | 10 working days | ||||||||
| Testing Schedule: | Weekly | ||||||||
| Testing Area: | Molecular Pathology | ||||||||
| Performing Site: | Foothills Medical Center | ||||||||
| Contact Comments: | Molecular Pathology South 402-220-4240 | ||||||||
| Last Updated On: | Tuesday, July 18, 2023 | ||||||||
| Date of Last Review: | Aug 1 2022 12:00AM | ||||||||
| Registered Trademark Comments: | PreservCyt® and CytoLyt® are registered trademarks of Hologic, Inc. and/or its subsidiaries. | ||||||||
