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Test Code TERTD TERT Promoter Mutation Analysis, Droplet Digital PCR, Tumor


Ordering Guidance


For the preferred test to assess for somatic hotspot mutations in the TERT, IDH1, and IDH2 genes, order IDTRT / IDH1, IDH2 and TERT Mutation Analysis, Next-Generation Sequencing, Tumor.

 

If this test is ordered with IDHT / IDH1 and IDH2 Mutations Analyses, Next-Generation Sequencing, Tumor, this test will be canceled and ordered as IDTRT.



Necessary Information


1. A pathology report (final or preliminary) is required and must accompany specimen for testing to be performed.

2. The following information must be included in the report provided.

-Patient name

-Block number-must be on all blocks, slides and paperwork (can be handwritten on the paperwork)

-Date of tissue collection

-Source of the tissue



Specimen Required


This assay requires at least 5% nuclei of tumor cells/cells of interest.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue144 mm(2)

-These amounts are cumulative over up to 10 unstained slides and must have adequate percent nuclei of tumor cells/cells of interest.

-Tissue fixation: 10% neutral buffered formalin, not decalcified

-Cytology fixatives: Cytology smears fixed in alcohol and thin preps fixed with CytoLyt.

 

Preferred:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable percent nuclei of tumor cells/cells of interest.

 

Acceptable:

Specimen Type: Tissue slides

Slides: 1 Hematoxylin and eosin stained and 10 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections.

Note: The total amount of required cell nuclei can be obtained by scraping up to 10 slides from the same block.

 

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1 to 3 slides

Collection Instructions: Submit 1 to 3 slides stained and coverslipped with a preferred total of 3000 nucleated cells or a minimum of at least 350 nucleated cells.

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned.


Useful For

Identifying specific mutations within the TERT promoter that assist in tumor diagnosis/classification

Additional Tests

Test ID Reporting Name Available Separately Always Performed
SLIRV Slide Review in MG No Yes

Testing Algorithm

When this test is ordered, slide review will always be performed at an additional charge.

Method Name

Droplet Digital Polymerase Chain Reaction (ddPCR)

Reporting Name

TERT Promoter Analysis ddPCR, Tumor

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Refrigerated 

Reject Due To

Specimens that have been decalcified (all methods)
Specimens that have not been formalin-fixed, paraffin-embedded excluding cytology slides
Extracted nucleic acid (DNA/RNA)
Reject

Reference Values

An interpretive report will be provided.

Interpretation

The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.

Day(s) Performed

Monday through Friday

Report Available

6 to 12 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

81345

88381-Microdissection, manual

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TERTD TERT Promoter Analysis ddPCR, Tumor 95778-7

 

Result ID Test Result Name Result LOINC Value
618698 Result Summary 50397-9
618699 Result 82939-0
618700 Interpretation 69047-9
618701 Additional Information 48767-8
618704 Specimen 31208-2
618705 Source 31208-2
618706 Tissue ID 80398-1
618702 Method 85069-3
618703 Disclaimer 62364-5
618707 Released By 18771-6