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Test Code CALR Calreticulin (CALR) Mutation Analysis

Additional Codes

Epic: LAB12701

Quest: 92475

Specimen Required

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/TypeLavender 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.

Specimen Minimum Volume

Whole blood: 3 mL

Bone marrow: 1 mL

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

Reference Range

See Laboratory Report

Rejection Due To

Do not reject specimens, send to laboratory for screening.

Day(s) and Time(s) Performed

Daily

Report Available

5-7 days

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.

Method Name

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.

CPT Code(s)

81219

Performing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Aliases

Polycythemia Vera (PV),PMF,PV,Primary Myelofibrosis (PMF),Essential Thrombocythemia (ET),ET,Myeloproliferative neoplasm