| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
RET/PTC Rearrangement, Thyroid Cancer
Test Code90473
CPT Codes
<strong>81479</strong>
Includes
RET/PTC1, RET/PTC3
Preferred Specimen
1 formalin-fixed, paraffin-embedded tissue block or needle washing
Minimum Volume
1 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.
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 Container
Paraffin-embedded tissue block
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?)
Do not reject
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
Daily
Reference Range
| RET/PTC1 | Not detected |
| RET/PTC3 | Not detected |
Clinical Significance
RET/PTC gene fusion is detected in 5-40% of papillary thyroid carcinomas, but has been reported at low frequency in other types of thyroid lesions. Correlation with morphologic and clinical findings is thus required.
The assay tests for both RET/PTC1 and RET/PTC3 rearrangements using a reverse transcription PCR assay. The lower limit of sensitivity is approximately 2.5% mutation-bearing cells in a mixed sample, but can vary due to RNA preservation.
The assay tests for both RET/PTC1 and RET/PTC3 rearrangements using a reverse transcription PCR assay. The lower limit of sensitivity is approximately 2.5% mutation-bearing cells in a mixed sample, but can vary due to RNA preservation.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
