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KIT D816V Mutation, paraffin

Test ID: M KIT P* CPT Code: 81273
Expected Turnaround Time
7 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
This KIT PCR assay aids in the diagnosis of mastocytosis and provides prognostic and predictive information for tyrosine kinase inhibitor (TKI) therapy planning. *Performed by affiliate laboratory.
Requisition Forms
Oncology Pathology Requisition

Specimen Requirements

Specimen Requirements
  • Whole Blood: 3mL (minimum 1mL), EDTA preferred (ACD or NaHep accepted)
  • Bone Marrow Aspirate: 3mL (minimum 1mL), EDTA preferred (ACD accepted)
  • Paraffin Embedded Bone Marrow Aspirate Clot: FFPE Block, 10% NBF Fixed
  • Refrigerated or Frozen Extracted DNA: 50 µl at 10 ng/µl
Specimen Stability
  • Whole Blood: 14 Days
  • Bone Marrow Aspirate: 14 Days
  • Paraffin Embedded Bone Marrow Aspirate Clot: Indefinite
  • Refrigerated/Frozen Extracted DNA: Long Term
Storage Requirements
  • Whole Blood: 2°C to 8°C
  • Bone Marrow Aspirate: 2°C to 8°C
  • Paraffin Embedded Bone Marrow Aspirate Clot: 15°C to 25°C
  • Refrigerated Extracted DNA: 2°C to 8°C
  • Frozen Extracted DNA: ≤ -15°C
Shipping Recommendations
  • Whole Blood: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Bone Marrow Aspirate: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Refrigerated Extracted DNA: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Frozen Extracted DNA: FROZEN, Ship samples on dry ice. Separate dry ice from specimens. 
  • Paraffin Embedded Bone Marrow Aspirate Clot: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
Specimen Rejection Criteria

Improper specimen labeling; Insufficient sample volume; Insufficient DNA isolated; specimens received outside of stability

Test Details

Synonyms

SCFR

Keywords
Leukemia, Molecular Diagnostics, Oncology, Hypereosinophilia / Mast Cell, Myeloproliferative Disease (MPD), Mutation Analysis, Gastrointestinal Cancer, Genomics
Test Method
Polymerase chain reaction (PCR)
Methodology Category
Molecular
Special Considerations
  • Frozen blood and bone marrow samples are NOT accepted.
  • Extracted DNA: Isolation of nucleic acids for clinical testing must occur in a CLIA-certified laboratory or a laboratory meeting equivalent requirements. Concentration and volume must be provided for all samples.
Associations

Mastocytosis, Seminoma, Human systemic mast cell disease