FLT3 ITD and TKD Mutation Assay
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Multiplex PCR and Capillary Electrophoresis
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
FLT3 (ITD) and TKD Mutation Assay
FLT3 ITD and D835 FORWARD
FLT3 ITD and D835 FORWARD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Submit only 1 of the following specimens:
Note: 1. If also ordering a Mayo test, send separate specimens
2. Clinical reason for referral (AML or CML) is required
3. Specimen source is required.
4. Date of collection is required
Draw blood in a lavender-top (EDTA), yellow-top (ACD), or green-top (sodium heparin) tube(s). Send 5 mL EDTA, ACD, or heparinized whole blood refrigerate.
Collect bone marrow in a lavender-top (EDTA), yellow-top (ACD), or green-top (sodium heparin) tube(s). Send 3 mL EDTA, ACD, or heparinized bone marrow refrigerate.
1 ug previously isolated DNA shipped refrigerate.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Blood 5 mL; Bone Marrow 3 mL
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Varies||Refrigerated (preferred)||7 days|
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.
*FLT3 Mutation Testing is performed pursuant to patents licensed from Takara Bio of Otsu, Japan.
Test Performed by: Laboratory for Personalized Molecular Medicine
6330 Nancy Ridge Drive, Suite 106
San Diego, CA 92121
Method Description Describes how the test is performed and provides a method-specific reference
Polymerase chain reaction (PCR) amplification for the detection of the FLT3 ITD and FLT3 TKD mutations was performed on DNA isolated from the patient sample. Fluorescently labeled primers amplified the sequences of interest. The TKD PCR product was cut with the EcoRV restriction enzyme. The ITD and the digested TKD products were run on the ABI 3500x1 genetic analyzer and their sizes were determined. The ITD wild type produces a fragment that is approximately 327 +/-1 bp, while the presence of an insertion produces a fragment that is approximately >=330 bp. This assay has an analytical sensitivity of 5 mutation containing cells in 100 total cells. This assay does not detect ITD mutations greater than approximately 420 bp in size.
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
3 - 7 days
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
5 - 9 days
Performing Laboratory Location The location of the laboratory that performs the test
Laboratory for Personalized Molecular Medicine
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by the Laboratory for Personalized Molecular Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration. However, such approval is not required for clinical implementation, and test results have been shown to be clinically useful. The Laboratory of Personalized Molecular Medicine is CLIA certified and CAP accredited to perform high complexity testing.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
81245 – FLT3 ITD mutation detection
81479 – Unlisted molecular pathology procedure
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|Z3562||FLT3 Internal Tandem Dup (ITD)||In Process|
|Z3277||FLT3 TKD Mutation||In Process|