Test Catalog

Test Id : TBRAF

Not Orderable

BRAF V600 Somatic Mutation Analysis, Tumor, Tissue

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Classifying and, possibly, targeting therapies of hematological neoplasms, such as hairy cell leukemia, Langerhans cell histiocytosis, Erdheim-Chester disease

Method Name
A short description of the method used to perform the test

Real Time PCR Amplification and Detection with a Qualitative Genotype Call

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

BRAF V600 Somatic Mutation, Tumor

Aliases
Lists additional common names for a test, as an aid in searching

BRAF

BRAF mutation

Erdheim-Chester disease

Hairy Cell leukemia

Langerhans cell histiocytosis

MBRAF

V600E

V600K

V600R

V600D

V600M

Specimen Type
Describes the specimen type validated for testing

Tissue, Paraffin

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

 

Ship paraffin blocks on ice packs during warm months

Necessary Information

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

2. At minimum, the following information must be included in the report provided:

1. Patient name

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

3. Tissue collection date

4. Source of the tissue

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
TBS1 Source

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block. Blocks prepared with alternative fixation methods will not be accepted; provide fixation method used

 

Acceptable:

Specimen Type: Tissue slides

Slides: 1 Hematoxylin and eosin stained and 4 or more unstained slides.

Collection Instructions:

1. A minimum of 10 percent tumor is required.

2. Submit 1 hematoxylin and eosin-stained slide and 4 to 10 unstained, nonbaked slides with 7 to 10-micron thick sections of the tumor tissue with an aggregate of 25 mm squared. 10 microns is preferred.

3. 5-micron sections will be accepted if a 50mm squared aggregate is cut

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Slides: 1 Hematoxylin and eosin-stained slide and 1 unstained slide for each probe set

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Specimens that have been decalcified (all methods)
Specimens that have not been formalin-fixed, paraffin-embedded 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Tissue, Paraffin Ambient (preferred)
Refrigerated

Useful For
Suggests clinical disorders or settings where the test may be helpful

Classifying and, possibly, targeting therapies of hematological neoplasms, such as hairy cell leukemia, Langerhans cell histiocytosis, Erdheim-Chester disease

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

This test uses DNA extracted from tissue to test for the presence of BRAF V600E/D and V600K/R/M alterations. BRAF mutations occur in many different types of human cancers. Testing for BRAF mutation in a blood or bone marrow specimen facilitates classification and possible targeted therapies of hematological neoplasms, such as hairy cell leukemia, Langerhans cell histiocytosis, and Erdheim-Chester disease. This is test is not designed for detection of BRAF mutations in liquid biopsy for tumors.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Positive and negative for V600, a somatic mutation

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided.

Results will be characterized as positive, negative, or indeterminate for a V600 somatic mutation.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Test results should be interpreted in context of clinical findings and other laboratory data. If results obtained do not match other clinical or laboratory findings, contact the laboratory for possible interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Maitre E, Cornet E Troussard X. Hairy cell leukemia: 2020 update on diagnosis, risk stratification, and treatment.Am J Hematol. 2019; 94(12):1413-1422

2. Rodriguez-Galindo C, Allen CE. Langerhans cell histiocytosis Blood. 2020;135(16):1319-1331

3. Haroche J, Cohen-Aubart F, Amoura Z: Erdheim-Chester disease Blood. 2020;135(16):1311-1318

Method Description
Describes how the test is performed and provides a method-specific reference

The Idylla is a fully automated real-time polymerase chain reaction-based molecular testing system that uses formalin-fixed, paraffin-embedded slides. This assay detects V600E/E2/D and V600K/R/M mutations in codon 600 of the BRAF gene.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Unused slides: 3 months; Extracted DNA: 1 year

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Jacksonville

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

81210

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
TBRAF BRAF V600 Somatic Mutation, Tumor 97025-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
616945 Result 97025-1
616943 Interpretation 69047-9
616947 Specimen 31208-2
TBS1 Source 31208-2
616954 Signing Pathologist 18771-6
616951 Method Summary 85069-3
616949 Sample ID 80398-1
616953 Disclaimer 62364-5
616946 Indication for Testing 48767-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2024-11-04