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Calreticulin (CALR) Mutation Analysis

Test Code
92475


CPT Codes
81219<br><strong>CPT coding may differ dependent on payer rules which may impact prior authorization testing.</strong><br><strong>Please direct any questions regarding CPT coding to the payer being billed.</strong>

Preferred Specimen
4 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube


Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate


Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in: Sodium heparin (green-top) tube • Fixed cell pellets collected in: Plastic leak-proof container • Extracted DNA from CLIA-certified laboratory collected in: Sterile leak-proof container


Transport Container
EDTA (lavender-top) tube


Transport Temperature
Room temperature


Specimen Stability
Whole blood, bone marrow, fixed cell pellet
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Extracted DNA
Room temperature:7 days
Refrigerated: 14 days
Frozen: 1 year


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
Daily


Reference Range
See Laboratory Report


Clinical Significance
This advanced DNA-based, next-generation sequencing (NGS) assay analyses leukocytes from blood or bone marrow aspirate for mutations in exon 9 of calreticulin (CALR). Frameshift mutations in this region of CALR are associated with myeloproliferative neoplasms (MPN), particularly essential thrombocythemia (ET) and primary myelofibrosis (PMF).


Performing Laboratory
Quest Diagnostics Nichols Institute-Chantilly VA
14225 Newbrook Drive
Chantilly, VA 20151-2228




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.