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LeukoVantage®, Myeloid

Test Code
39194


CPT Codes
81450

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


Minimum Volume
2 mL whole blood or bone marrow • 20 uL of 10 ng/uL extracted DNA


Other Acceptable Specimens
Whole blood or bone marrow collected in: sodium heparin (green-top) tube • 50 uL of 10 ng/uL extracted DNA submitted in a microcentrifuge tube


Instructions
Requisition form and Pathology/Flow Cytometry Report are required. In addition, only accept extracted DNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.


Transport Temperature
Room temperature


Specimen Stability
EDTA Whole blood and bone marrow
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

Heparin Whole blood and bone marrow
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Extracted DNA
Room temperature: 30 days
Refrigerated: 2 years
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Clotted blood sample • Gross hemolysis


Methodology
Next Generation Sequencing

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Tuesday, Thursday Morning
Report available: 11 Days


Reference Range
See Laboratory Report


Clinical Significance
This test is designed to aid in diagnosis, prognosis and/or treatment strategy for patients with AML, MPN and MDS.




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.