IGH Somatic hypermutation analysis, B-cell chronic lymphocytic leukemia (B-CLL)-994

Test info

  
IGH Somatic hypermutation analysis, B-cell chronic lymphocytic leukemia (B-CLL)
  
994
  
LAB994
  
MSO
  
BCLL
CLL prognosis
IGVH heavy chain mutation
IGHV
IGVH
Next Gen Sequencing test
  

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

Specimen

  
EDTA whole blood
  
  
4.0 mL
  
1.0 mL
  

Immediately after collection, mix tube thoroughly by gentle inversion, 8 - 10 times, to prevent clotting

  

Lavender (EDTA), 4mL

  
ACD whole blood
Bone marrow in EDTA or ACD
Extracted DNA from blood or bone marrow
  

Yellow ACD (A or B)

  

  
ACD whole blood 4.0 mL (minimum 1.0 mL)
Bone marrow 2.0 mL (minimum 1.0 mL)
Extracted DNA minimum 50mcL at 20ng/mcL extracted DNA
  

Bone Marrow (in EDTA or ACD):

  1. Immediately following collection, mix sample thoroughly by gently inverting 8 - 10 times, to prevent clotting
  2. Send specimen in original tube, labelled as bone marrow

Extracted DNA from whole blood or bone marrow:

  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.
  

Bone marrow:

Lavender (EDTA), 4mL

Yellow ACD (A or B)

Extracted DNA:

1.5 to 2mL screw-top tube (extracted DNA)

  

B-Cell Chronic Lymphocytic Leukemia (CLL) for IGVH and/or TP53 Somatic Mutation Testing form

Molecular Medicare Billing Request

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.

  

Whole blood or Bone marrow:

Refrigerated (preferred) - 7 days

Ambient - 7 days

 

Extracted DNA:

Frozen (preferred)

Refrigerated

 

  
  • Gross hemolysis
  • Moderate to severly clotted sample

Performance

  
Mayo Clinic Laboratories (BCLL): R-NX
  
Mo, We, Fr
  
2 weeks
  

Polymerase Chain Reaction (PCR) and Next-Generation Sequencing for IGH Somatic Mutation Status in CLL

Clinical and Interpretive info

  

An interpretive report will be provided

Billing

  
This test may require preauthorization from the insurance provider. Check the payer guidelines and, if needed, obtain the pre-authorization prior to sample collection.
  
81263 - IGH
  
Yes
  

Medical necessity

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.

Molecular Medicare Billing Request

Tracking

  
10/20/2016
  
05/23/2024
  
01/02/2024