B Cell Clonality by PCR

General Information

Lab Name

Lab Code

BCELL

Epic Ordering

B Cell Clonality by PCR

Description

Monoclonal populations of B lymphocytes can be identified by testing for immunoglobulin heavy chain (IGH) and kappa light chain gene (IGK) rearrangement by the polymerase chain reaction. Our method, developed by the collaborative European BIOMED-2 Concerted Action study group, employs three multiplex primer sets, each recognizing one of three conserved “Framework Regions” (FR1, FR2, and FR3) of (IGH) variable gene segments (VH) and two multiplex primer sets targeting the kappa light chain locus (IGK).

For patients whose lymphoma has been shown to have a detectable clonal B cell population, this assay can be used in the post-treatment context of B cell depleted specimens. However, this test is not sufficiently sensitive for post-treatment monitoring of B lymphoblastic leukemia; consider send-out testing for next-generation sequencing of IGH.

Sensitivity: This assay detects approximately 90% of B cell clones, provided that the clonal population represents at least 2-5% of the B cells in a specimen.

Hematopathology test request form can be found at Request Form.

Forms & Requisitions

Requisition

Synonyms

B cell gene rearrangement, B-cell clonality analysis, B-cell gene rearrangement, IgH gene clonality, IgH gene rearrangement, IgK gene clonality, IgK gene rearrangement

Components

Code	Name
BCELSD	B Cell Clonality PCR Specimen
BCELRS	B Cell Clonality PCR Result
BCELIN	B Cell Clonality PCR Interp
BCREV	B Cell Clonality Results Reviewed by:
BCELM	B Cell Clonality PCR Method
BCRGRN	B Cell Clonality Case Number

Interpretation

Method

Polymerase Chain Reaction (PCR)/Capillary Electrophoresis

Reference Range

See individual components

Guidelines

Molecular Testing for Hematopoietic Disorders

Ordering & Collection

Specimen Type

Blood, Bone Marrow, Tissue - Fresh, frozen or FFPE/PET (Blocks), Fluids, Slides, Sorted Cells

Collection

Preferred:
Blood: 6mL in Lavender Top (EDTA)

Bone Marrow: 1-2mL in Lavender Top (EDTA)

Tissue, Fluids or Sorted cells: Sterile container in RPMI

Formalin-fixed paraffin embedded tissue (FFPE/PET) block

Slides: 10 unstained

Accepted:
Green Tops (Heparin), while green tops are accepted for testing, there is documentation that heparin can interfere with some PCR assays.

Extracted DNA from CLIA certified laboratory.

Formalin-fixed paraffin embedded tissue (FFPE/PET)

Tissue from curls cut from FFPE/PET blocks or stained cover-slipped slides

Unacceptable:
Specimens received beyond stability limit.
Specimens with low volume or inadequate WBC
Decalcified or unacceptable fixatives

Forms & Requisitions

Requisition

Handling Instructions

Deliver samples to Hematopathology as soon as possible.
If sample is older than 48 hours, please store at 2-6°C upon receipt and send refrigerated.
Samples stored at room temperature or refrigerated older than 7 days will be rejected.
Frozen samples should be shipped on dry ice.

Quantity

requested: Blood: 6mL EDTA/BMA: 1-2mL EDTA/Tissue Blocks: Adequate size to cut 10-20 curls/Slides: 10 unstained
minimum: Blood: 1mL EDTA/ BMA: 0.5mL EDTA/Tissue Blocks: 5 curls/Slides: 5 slides

Processing

Processing: Send specimens to Hematopathology – Molecular department for processing.
The stability limit for Blood and Bone Marrow is 7 days, samples beyond this limit will be rejected.

Blood and BMA must arrive in lab by 7am and tissue by 12pm Friday to be included on Tuesday run.

Performance

LIS Dept Code

Molecular Hematopathology (MHP)

Performing Location(s)

Other	Hematopathology, Molecular 206-606-7060 UW Hematopathology Laboratory, G7-800 Fred Hutchinson Cancer Center 825 Eastlake Avenue E. Seattle, WA 98109	Hematopathology, Molecular hours: 7:00 am - 5:30 pm M-F 8:00 am - 4:30 pm Saturday, closed on Sunday, and with reduced staffing on major holidays

Frequency

Tuesday and Thursday: Results available up to 5 days.

Available STAT?

Billing & Coding

CPT codes: 81261, 81264
LOINC: 21747-1
Interfaced Order Code: UOW2785