Test Catalog

Test Id : MBRAF

Not Orderable

BRAF V600 Somatic Mutation Analysis, Bone Marrow

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Overview

Test Catalog

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

Classification and/or possible targeted 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

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, BM

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

Bone Marrow

Shipping Instructions

Specimen must arrive within 7 days of collection.

Necessary Information

The following information is required:

1. Pertinent clinical history

2. Clinical or morphologic suspicion

3. Date of collection

4. Specimen source

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

Container/Tube: Lavender top (EDTA) or yellow top (ACD solution B)

Specimen Volume: 2 mL

Collection Instructions:

1. Invert several times to mix bone marrow.

2. Send bone marrow specimen in original tube. Do not aliquot.

3. Label specimen as bone marrow.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

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

Gross hemolysis Reject
Moderately to severely clotted 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
Bone Marrow Ambient (preferred) 7 days
Refrigerated 7 days

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

Classification and/or possible targeted 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 the bone marrow 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 mutations in bone marrow specimens 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 of 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.

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, please 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

Polymerase chain reaction-based assay using bone marrow sample. This test detects the most common mutation V600E and other variants at the same codon. The limit of detection for this assay is approximately 1%. The mutation is reported using the current standard nomenclature.(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

Bone marrow: 2 weeks; 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
MBRAF BRAF V600 Somatic Mutation, BM 85101-4
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.
616930 Result 85101-4
616928 Interpretation 59465-5
616939 Signing Pathologist 18771-6
616936 Method Summary 85069-3
616934 Sample ID 80398-1
616938 Disclaimer 62364-5
616931 Indication for Testing 42349-1
616952 Specimen 31208-2
616933 Source 31208-2

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 | PHP Pdf | CMS 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