Test Overview
Test Methodology

Multiplex Polymerase Chain Reaction (PCR) with Capillary Electrophoresis

Test Usage

The FLT3 gene encodes a cell surface receptor tyrosine kinase that is expressed on early hematopoietic stem cells. Activating mutations in FLT3 occur in approximately 25-30% of patients with acute myelogenous leukemia (AML). The mutation generally occurs as either an internal tandem duplication (ITD) within the juxtamembrane domain, or as a missense point mutation within the tyrosine kinase domain (TKD) at codon 835. This test detects both the FLT3-ITD and FLT3-TKD (codon 835) mutations. The presence of a FLT3-ITD mutation has been associated with a significantly poorer outcome in normal karyotype AML.

Reference Range *

Interpretive report provided.

Test Limitations

The limit of detection of this assay is 10% mutation-bearing cells. Mutations may not be detected in samples with a neoplastic burden below this level.

Test Details
Days Set Up
Monday - Friday
Analytic Time

2 - 7 days

Soft Order Code
FLT3
MiChart Code
FLT3 Mutation Detection
Synonyms
  • FLT3S
  • FLT3 Gene Mutation Analysis
  • MLABEL
  • FLT3
  • FLT3 ASSAY
Laboratory
Molecular Diagnostics
Section
Molecular Diagnostics
Specimen Requirements
Collection

Collect blood or bone marrow specimen in a lavender top (EDTA) tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection.

Collection Instructions

Collect blood or bone marrow in a lavender top tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection. Fresh tissue (preferably 0.5cm3, sent in RPMI) and fresh aspirates or body fluids are acceptable. Refrigerate and send, preferably within 24 hours. Frozen tissue specimens – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fresh cell suspensions in RPMI should be refrigerated and sent, preferably within 48 hours. Frozen cell suspensions – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fixed cytogenetic cell suspensions or pellets in Carnoy’s fixative. Refrigerate and send.

Alternate Specimen
The preferred specimen is whole blood or bone marrow collected in EDTA (lavender top). However, ACD (yellow top) and heparin (green top) may also be accepted.
Rejection Criteria
Formalin-fixed paraffin-embedded specimens are not acceptable.
Lavender Top Tube
Normal Volume
5 mL EDTA (lavender) whole blood; 3 mL EDTA (lavender) bone marrow; Fresh/frozen tissue and fresh aspirates or body fluids; Fresh/frozen cells in RPMI; Fixed cytogenetic cell suspensions or pellets in Carnoy's fixative. Extracted DNA will be accepted from specimens that were not extracted from formalin-fixed specimens, if extracted in a CLIA certified laboratory.
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing
CPT Code
81245, 81246
Fee Code
NA010, NA011
Pro Fee CPT
G0452-26
LOINC
Z500-9
NY State Approved
No