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B Cell Clonality by PCR

Important Note

This test is under Utilization Management. All requests are reviewed and must be approved by a pathologist as part of the lab stewardship program.

Clinical System Name

Miscellaneous Test


B cell gene rearrangement

B-cell clonality analysis

B-cell gene rearrangement

IgH gene clonality

IgH gene rearrangement

IgK gene clonality

IgK gene rearrangement

Sample Requirements

Specimen: Whole Blood or Bone Marrow

Container(s): Lavender/EDTA

Preferred Vol: 10.0 mL Whole Blood or 2.0 mL Bone Marrow

Minimum Vol: 5.0 mL Whole Blood or 1.0 mL Bone Marrow


Note: While green top tubes are accepted for testing, there is documentation that heparin can interfere with some PCR assays.

Processing Instructions

Reject due to:

Spin: N

Aliquot: N

Temp: 2 - 4 C

Storage Location: CPA 3 Refrigerator, Send Outs rack.


Off-site Collection:


Specimen Type Temperature Time
Whole Blood or Bone Marrow Room Temp 24 h
  Refrigerated 4 d
  Frozen Unacceptable



STAT Performed TAT
N T 10 - 12 d


Performing Laboratory

UW / Seattle Cancer Care Alliance

Hematopathology Laboratory

825 Eastlake Avenue E., G7-800

Seattle, WA 98109


Phone Number: (206) 288-7060

Intake Hours: Monday - Friday 08:00 - 18:30 PST



Department: Send Outs

Phone Number: (206) 987-2563

CPT Codes

81261, 81264


Method: Polymerase Chain Reaction (PCR)/Capillary Electrophoresis

Analytical Volume: 5.0 mL Whole Blood or 1.0 mL Bone Marrow


Send Out Instructions

Reference Test Name: B Cell Clonality by PCR
Reference Test Code: BCELL
Instructions: Send Monday through Friday with the UW courier.



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). In a mixed population of B cells, the lymphoma cells must represent at least 1% of the total B cells in order to be detectable as clonal peaks in a polyclonal distribution of background peaks. Approximately 90% of B cell lymphomas produce a PCR product using the BIOMED-2 (IGH) and (IGK) primer sets. For patients whose lymphoma has been shown to have a detectable clonal B cell population, this assay can be a sensitive detector of minimal residual disease in post treatment, B cell depleted specimens.

Reference Ranges

Interpretive report provided.