ARUP's Laboratory Test Directory
| 0080377: FLT3 Mutation Detection by PCR |
| Test Mnemonic: FLT3 ITD | |
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Methodology: Polymerase Chain Reaction
Performed: Sun-Sat Reported: 4-7 days |
| Specimen Required: | |
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Collect: One 5 mL whole blood or bone marrow in a lavender (EDTA) or pink (K2EDTA).
Transport: 5 mL whole blood or 3 mL bone marrow at 2-8°C. (Min: 1 mL) Pediatric Collection/Transport: 1 mL whole blood or bone marrow at 2-8°C. Unacceptable Conditions: Frozen specimens. Stability: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable |
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| Reference Interval: |
| By report |
| Interpretive Data: | |
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Patient DNA was isolated, purified and subjected to PCR amplification using specific oligonucleotide primers directed at exons 14, 15, and 20 of the FLT3 gene. Each assay includes a positive control reaction using DNA from a specimen or cell line known to contain an FLT3 ITD mutation or exon 20 point mutation and a negative control reaction using DNA from a specimen or cell line containing the wild-type FLT3 sequence. Amplicons for exon 20 are digested with EcoR V. PCR products are separated by capillary gel electrophoresis and detected by fluorescence. The limit of detection for this assay is 1 in 20 cells. A postivie result indicates the presence of FLT3 ITD or exon 20 point mutation. A negative result does not entirely exclude the presence of an FLT3 gene Results of this test must always be interpreted in the context of clinicopathologic and relevant data, and should not be used alone for a diagnosis of malignancy. This test is not intended to detect minimal residual disease. Please refer to Statement B in the Compliance Statements section in the front of the Laboratory Test Directory. |
| Note: | |
| Testing performed at Laboratory for Personalized Molecular Medicine (LabPMM) except for specific states. This test is conducted under a sublicense to U.S. Patent No. 6,846,630 owned by Takara Bio, Inc. of Otsu, Japan and licensed exclusively to IVS Technologies, LLC of San Diego, California. |
| CPT Code(s): | |
| 83891 Isolation; 83898 x2 Amplification; 83892 Enzymatic Digestion; 83896 x2 Nucleic acid probes; 83909 Separation and identification; 83912 Interpretation and report - Additional CPT code modifiers may be required for procedures performed to test for oncologic or inherited disorders. |