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BRAF Mutation Analysis, Papillary Thyroid Cancer
Test Code90477
CPT Codes
81210
Preferred Specimen
1 formalin-fixed, paraffin-embedded tissue block OR needle washing
Instructions
Do not reject. Needle washings in alcohol based fixative (e.g. CytoLyt®) or Formalin fixed, paraffin embedded tissue block FNA or FFPE specimens are acceptable for the assay. All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.
Transport Temperature
Room temperature
Specimen Stability
FNA or FFPE
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Needle washings
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Needle washings
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sample received frozen
Methodology
Real-Time Polymerase Chain Reaction (PCR)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Sets up 7 days a week.
Clinical Significance
BRAF V600E mutations are found in 40-50% of papillary thyroid carcinoma (PTC), and much less commonly in anaplastic thyroid carcinoma or poorly differentiated carcinomas involving the thyroid. Correlation with morphologic and clinical findings is thus required.
