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Test Code BCLL IGH Somatic Hypermutation Analysis, B-Cell Chronic Lymphocytic Leukemia (B-CLL), Varies

Additional Codes

CNE Order Code: BCLL

Useful For

Providing prognostic information in patients with newly diagnosed B-cell chronic lymphocytic leukemia

 

This test is not intended for use in providing prognostic information for patient with other B-cell neoplasms or hematopoietic tumors.

Reporting Name

IGH Somatic Hypermutation in B-CLL

Specimen Type

Varies


Shipping Instructions


1. Both refrigerated and ambient specimens must arrive within 7 days of collection.

2. Collect and package specimen as close to shipping time as possible.



Necessary Information


1. Molecular Hematopathology Patient Information is required.. Testing may proceed without the patient information; however, it aids in providing a more thorough interpretation. Ordering providers are strongly encouraged to fill out the form and send with the specimen.

2. If form is not provided, include the following information with the test request: specimen source, pertinent clinical history (ie, complete blood cell count results and relevant clinical notes), and clinical or morphologic suspicion.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Whole blood

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Yellow top (ACD)

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.

Specimen Stability: Refrigerated/Ambient

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Yellow top (ACD)

Specimen Volume: 2 mL

Collection Instructions:

1. Invert several times to mix bone marrow.

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

3. Label specimen as bone marrow.

Specimen Stability: Refrigerated/Ambient

 

Specimen Type: Extracted DNA from blood or bone marrow

Container/Tube: 1.5- to 2-mL screw-top tube

Specimen Volume: Entire specimen

Collection Instructions:

1. Label specimen as extracted DNA and indicate specimen source (blood or bone marrow).

2. The required volume of DNA is 50 mcL at a concentration of 20 ng/mcL.

3. Include volume and concentration on tube.

Specimen Stability: Frozen (preferred)/Refrigerated


Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies 7 days

Reject Due To

Gross hemolysis Reject
Moderately to severely clotted Reject

Reference Values

An interpretive report will be provided.

Interpretation

The presence or absence of somatic hypermutation (SHM) in the immunoglobulin heavy chain gene (IGH) variable (V) region DNA will be reported. A variation frequency of greater than 2% will be reported as mutated. Both the percent mutation and the V region allele identified in the rearrangement will be included in the report.

 

B-cell chronic lymphocytic leukemia (B-CLL) lacking SHM of the IGH V region (unmutated) is associated with a significantly worse prognosis than B-CLL containing SHM of the IGH V region (mutated).

Day(s) Performed

Monday, Wednesday, Friday

Report Available

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

81263-IGH (immunoglobulin heavy chain locus) (eg, leukemia and lymphoma, B-cell), variable region somatic mutation analysis

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BCLL IGH Somatic Hypermutation in B-CLL 50627-9

 

Result ID Test Result Name Result LOINC Value
39465 BCLL Result No LOINC Needed
MP005 Specimen Type 31208-2
19674 Final Diagnosis 50398-7

Method Name

Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS)

Specimen Minimum Volume

Blood/Bone marrow: 1 mL
Extracted DNA: see Specimen Required

Forms

1. Molecular Hematopathology Patient Information is required.

2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.