Test Name
IgVH Mutational Status by NGS
Test Code
M IgVH
Associations
Chronic Lymphocytic Leukemia, CLL / SLL
CPT Codes
81263
Turnaround Time
10 days
Specimen Requirements
5.0 mL (min. 1.0 mL) whole blood EDTA preferred, heparin whole blood accepted 3.0 ml (min. 1mL) bone marrow aspirate EDTA preferred, heparin accepted
Specimen Stability
EDTA whole blood or bone marrow stable at room temperature (18-25°C)
Storage & Handling
Whole blood and bone marrow ship in a Styrofoam container with a cool pack. (Do not allow cool/refrigerated pack to directly contact samples)
Causes for Rejections
Insufficient volume; Specimen at incorrect temperature; Incorrect anticoagulant
Description
CLL/SLL is the most common leukemia diagnosed among adults in Western countries and is associated with heterogeneous clinical outcomes. IgVH somatic hypermutation (SHM) status is a primary component of the CLL International Prognostic Index (CLL-IPI) work
References
Read more about IgVH Somatic Hypermutation testing at MPLN here.
- International CLL-IPI working group. An international prognostic index for patients with chronic lymphocytic leukaemia (CLL-IPI): a meta-analysis of individual patient data. Lancet Oncol. 2016 Jun;17(6):779-90.
- Duncavage et al, Template for Reporting Results of Biomarker Testing of Specimens From Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Arch Pathol Lab Med. 2016 Apr 15.
- Wilhelm C, Neubauer A, Brendel C. 2006. Discordant results of flow cytometric ZAP-70 expression status in B-CLL samples if different gating strategies are applied. Cytometry B Clin Cytom. 2006 Jul 15;70(4):242-50.
- Sheikholeslami MR et al. Variations in the detection of ZAP-70 in chronic lymphocytic leukemia: Comparison with IgV(H) mutation analysis. Cytometry B Clin Cytom. 2006 Jul 15;70(4):270-5.
- Szankasi P, Bahler DW. Clinical laboratory analysis of immunoglobulin heavy chain variable region genes for chronic lymphocytic leukemia prognosis. J Mol Diagn. 2010 Mar;12(2):244-9.
- Rassenti et al. ZAP-70 compared with immunoglobulin heavy-chain gene mutation status as a predictor of disease progression in chronic lymphocytic leukemia. N Engl J Med. 2004 Aug 26;351(9):893-901.
