A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #

Calreticulin (CALR) Mutation Analysis

Test Code
CALR


Alias/See Also

LAB12701



CPT Codes
<p>81219</p>

Preferred Specimen

Submit only 1 of the following specimens:




Specimen Type: Whole blood


Collection Container/Type: Lavender top (EDTA) or yellow top (ACD solution B)


Specimen Volume: 4 mL


Collection Instructions: 


1. Invert several times to mix blood.


2. Send whole blood specimen in original tube. Do not aliquot.


3. Label specimen as blood.


Additional Information: Do not reject specimens, send to laboratory for screening.


 


Specimen Type: Bone marrow


Collection Container/Type: Lavender top (EDTA) or yellow top (ACD solution B)


Specimen Volume: 3 mL


Collection Instructions: 




  1. nvert several times to mix bone marrow.




  2. Send bone marrow specimen in original tube. Do not aliquot.




  3. Label specimen as bone marrow.




Additional Information: Do not reject specimens, send to laboratory for screening.


 


Specimen Type: Extracted DNA from blood or bone marrow


Collection Container/Type: 1.5- to 2-mL tube


Specimen Volume: Entire specimen


Collection Instructions: Label specimen as extracted DNA from blood or bone marrow and include indication of volume and concentration of the DNA.


Additional Information: Do not reject specimens, send to laboratory for screening.



Minimum Volume

Whole blood: 3 mL


Bone marrow: 1 mL



Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in a sodium heparin (green-top) tube • Fixed cell pellet collected in a plastic leak-proof container • Extracted DNA from CLIA-certified laboratory collected in a sterile leak-proof container


Instructions
Do not reject specimens, send to laboratory for screening.

Cell Pellets: Send fixed samples within 7 days of fixation date in a plastic, leak-proof tube/container. Indicate type of fixative used along with patient name, specimen source, date collected, and date harvested/fixed. Cell pellets submitted in Carnoy's or other alcohol-based fixatives are acceptable.


Transport Temperature
Room temperature


Specimen Stability

Whole blood, bone marrow aspirate


Room temperature: 7 days


Refrigerated: 7 days


Frozen: Unacceptable


 


Extracted DNA


Room temperature: 7 days


Refrigerated: 14 days


Frozen: 1 year



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

Do not reject specimens, send to laboratory for screening.



Methodology

Polymerase Chain Reaction-based DNA Sequencing

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



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 the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 5-7 days


Report Available

5-7 days



Reference Range
See Laboratory Report


Clinical Significance
This DNA-based assay tests leukocytes from blood or bone marrow aspirate for mutations in exon 9 of calreticulin (CALR), using an advanced DNA sequencing method. Frameshift mutations in this region of CALR are associated with myeloproliferative neoplasms, particularly essential thrombocythemia and primary myelofibrosis.


Performing Laboratory
Quest Diagnostics Nichols Institute 14225 Newbrook Drive Chantilly, VA 20153


Last Updated: February 17, 2023


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.