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

Important Note

This test subject to Local Coverage Determination (LCD) Molecular Pathology Procedures (L35000).

Please check with the patient's insurance to determine if prior authorization is necessary.  If in doubt about the coverage for a Medicare patient, please obtain an ABN.

Additional Codes

Orderable Codes:

Epic Code Atlas Code Mayo Test ID Order LOINC
LAB16858 LAB16858 BCLL 50627-9

Result Component(s):

Reporting Name Epic Code Atlas Code Mayo Test ID Result LOINC
Final Interpretation 12301021539 M622044 622044 N/A
BCLL Result 12301015849 M39465 39465 N/A
Specimen Type 12301015850 MMP005 MP005 31208-2
Primer Set 12301021540 M622055 622055 104271-2
Primary V-gene 12301021541 M622045 622045 104269-6
Primary J-gene 12301021542 M623097 623097 104270-4
Primary Mutation Status % 12301021543 M622046 622046 107552-2
Primary Mutation Status 12301021544 M622047 622047 107551-4
Primary Rearrangement Status 12301021545 M622048 622048 21747-1
Primary Subset 12301021546 M622053 622053 107550-6
Secondary V-gene 12301021547 M622049 622049 104269-6
Secondary J-gene 12301021548 M623098 623098 104270-4
Secondary Mutation Status % 12301021549 M622050 622050 107552-2
Secondary Mutation Status 12301021550 M622051 622051 107551-4
Secondary Rearrangement Status 12301021551 M622052 622052 21747-1
Secondary Subset 12301021552 M622054 622054 107550-6
Final Diagnosis 12301015851 M19674 19674 50398-7

 

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


 



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 whole blood.

Specimen Stability: Refrigerated (preferred) 7 days/Ambient 7 days

Additional Information: To ensure minimum volume and concentration of DNA are met, the requested volume must be submitted. Testing may be canceled if DNA requirements are inadequate.

 

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: Ambient (preferred) 7 days/Refrigerate 7 days

Additional Information: To ensure minimum volume and concentration of DNA are met, the requested volume must be submitted. Testing may be canceled if DNA requirements are inadequate.

 

Specimen Type: Extracted DNA from whole blood or bone marrow

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

Specimen Volume: Entire specimen

Collection Instructions:

1. DNA must be extracted from blood or bone marrow within 7 days of collection.

2. Label specimen as extracted DNA and source of specimen

3. Provide volume and concentration of the DNA

Specimen Stability Information: Frozen (preferred)/Refrigerate/Ambient

Additional Information:

1. Specimens are preferred to be received within 1 year after DNA extraction.

2. DNA must be extracted in a CLIA-certified laboratory or equivalent and must be extracted from a specimen type listed as acceptable for this test (including applicable anticoagulants). We cannot guarantee that all extraction methods are compatible with this test. If testing fails, one repeat will be attempted, and if unsuccessful, the test will be reported as failed and a charge will be applied.


Specimen Stability Information

Specimen Type Temperature Time
Varies Varies

Reject Due To

Gross hemolysis Reject
Moderately to severely clotted Reject

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

14 days

Specimen Retention Time

Whole blood/Bone marrow: 2 weeks; Extracted DNA: 3 months

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

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
622044 Final Interpretation No LOINC Needed
39465 BCLL Result No LOINC Needed
MP005 Specimen Type 31208-2
622055 Primer Set 104271-2
622045 Primary V-gene 104269-6
623097 Primary J-gene 104270-4
622046 Primary Mutation Status % 107552-2
622047 Primary Mutation Status 107551-4
622048 Primary Rearrangement Status 21747-1
622053 Primary Subset 107550-6
622049 Secondary V-gene 104269-6
623098 Secondary J-gene 104270-4
622050 Secondary Mutation Status % 107552-2
622051 Secondary Mutation Status 107551-4
622052 Secondary Rearrangement Status 21747-1
622054 Secondary Subset 107550-6
19674 Final Diagnosis 50398-7

NY State Approved

Yes

Method Name

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

Specimen Minimum Volume

Whole blood/Bone marrow: 1 mL; Extracted DNA: 50 mcL at a concentration of 20 ng/mcL.

Forms

1. Molecular Hematopathology Patient Information (T711).

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