KIT (D816V) Mutation by ddPCR, Quantitative

Test Code

18329

CPT Codes
81273<br>Restricted Client Code

Preferred Specimen

5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube

Minimum Volume

1 mL

Other Acceptable Specimens

Whole blood or bone marrow collected in: sodium heparin (green-top) tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Plasma • Serum • FFPE tissue blocks/slides or fresh or frozen tissue • Specimens collected in anticoagulants other than EDTA or sodium heparin • Clotted specimens

Methodology
Droplet Digital Polymerase Chain Reaction (ddPCR)

FDA Status
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical purposes.

Setup Schedule

Set up: Varies; Report available: 2-9 days

Reference Range

See Laboratory Report

Clinical Significance

Aids in the diagnosis of mastocytosis. Provides prognostic and predictive information for tyrosine kinase inhibitor (TKI) therapy planning.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.