Unique Identifier:
ML-H023
Name on Requisition:
IGHV hypermutation
Product Line:
HEME
Panel Group:
NGS
Methodology
Molecular
NGS
Test Description and clinical significance
Genes
IGHV hypermutation
Disease:
CLL
Immunoglobulin Heavy Chain Variable Region (IGHV) hypermutation status is an important biomarker in chronic lymphocytic leukemia (CLL). The degree of somatic hypermutation in the IGHV gene stratifies patients into prognostic subgroups: unmutated IGHV is associated with more aggressive disease and shorter time to treatment, whereas mutated IGHV is associated with a more favorable clinical course. This assay determines the IGHV mutation status by comparing the patient sequence to germline reference, providing critical diagnostic and prognostic information.
Specimen Requirements
Preparation:
PB, BM
Collection:
At least 0.5 ml EDTA, citrate (ACD) or Heparinized whole blood or bone marrow aspirates for DNA mutations
Stability:
96hours/4 to 7 days refrigerated
Unacceptable Conditions:
Specimen submitted is in the incorrect fixative or anticoagulant. Specimen received after the stability date. Gross hemolysis. Frozen specimen. Insufficient specimen. Unlabeled. Left un-refrigerated for an extended period.
Storage & Transport
Blood or bone marrow specimens should be kept at room temperature and preferably received within 96 hrs of drawing. Samples that are 4 to 7 days old should be refrigerated. Sufficient quantity of previously extracted DNA is acceptable if stored at appropriate temperature (short term at 2–8oC or long term at -15 to -25 oC) and should be transported on ice.
CPT(s)
81263
New York Approved
Yes
TAT
5
Requisition Type
Heme
Levels of Service
Full
DexS Code
Z00TE
Prefix
MI
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
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