B-Cell Clonal Study

Last Modified: 2/13/2019 12:49:06 PM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements: 4.0 mL Whole Blood in a Green Top Tube - Na Heparin
and
3.0 mL Whole Blood in a Lavender Top Tube - EDTA
Collection Instructions:

Specimens collected with Lithium Heparin tubes will be rejected

Transport & Storage: Temperature/Stability: 24 to 48 hours Ambient
Reference Range: Refer to Interpretive Flow Results

See CBC for its Reference Ranges
Critical Ranges:  
Test Comments:
The specimen is prepared by a whole blood lysis method and stained with monoclonal antibodies using a direct immunofluorescence method. Surface Kappa and Lambda light chain staining is performed with polyclonal antibodies following ammonium chloride lysis. The cells are separated by Flow Cytometry based on light scatter characteristics. The percentages of cells positive within the predominantly lymphocyte subpopulation are reported.

A Complete Blood Count will be reflexed, and charged with the ordering of this test
Methodology: Flow Cytometry
Clinical Significance:
Useful for the investigation of lymphocytosis of unknown origin in order to determine clonality identification of B-Cell and T-Cell chronic lymphoproliferative disorders
Documentation:
This test was developed and the performance characteristics determined by Parkview Health Laboratories. This test has not been cleared by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 48 to 72 hours
Days Performed: Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Parkview Regional Medical Center
PHL Test Code: FBCLL
EPIC Test Code: LAB2453
Alternate Test Names: CLL Panel; Flow Cytometry B-Cell Clonal
Included Tests: CBC [Automated Differential; Hematocrit (Hct); Hemoglobin (Hgb); Mean Corpuscular Hemoglobin (MCH); Mean Corpuscular Hemoglobin Concentration (MCHC); Mean Corpuscular Volume (MCV); Platelet (PLT);  Red Blood Cell Count (RBC); Red Cell Distribution Width Standard Deviation (RDWSD);  Red Cell Distribution Width Coefficient Variation (RDWCV); White Blood Cell Count (WBC)]; CD2; CD3; CD4; CD5; CD7; CD8; CD10; CD19; CD20; CD23; CD38; CD45; CD56; FMC7; Surface Kappa; Surface Lambda;
CPT Coding: 88184, 88185 x 15

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