Performed

Monday - Friday

Methodology

Polymerase Chain Reaction / Capillary Electrophoresis

Reported

Routine: 5 - 7 days

Synonyms

  • IGH and IGK B Cell Clonality, Blood
  • Blood, IgH and IgK B-Cell Clonality
  • B-Cell Clonality, IgH and IgK
  • Clonality Assessment
  • Lymphoid Malignancies
  • Lymphoid Malignancy
  • B Lymphocytes
  • Clonal B Lymphocytes
  • Clonal B-cells
  • B-Cell Clonality Screening
  • Screening, B-Cell Clonality
  • Clinical Genomics

Performing Lab

Clinical Genomics

Turnaround Time

7 days

Add-on Eligibility

Yes, within 7 days of collection
*If DNA has been extracted previously for other Clinical Genomics tests, this is stored for 6 weeks and may qualify for add-on

Specimen Type

Blood

Specimen Volume

5 mL (Minimum: 1 mL)

Collection Container

EDTA Whole Blood Tube (Lavender Top Vacutainer)

Unacceptable Conditions

  1. Severely clotted or grossly hemolyzed specimens
  2. Specimens that have been improperly collected, stored, or transported
  • Specimens collected in preservatives other than EDTA
    • ACD tubes are accepted, but EDTA is preferred
    • Heparinized specimens are accepted, but not recommended
  • Serum or plasma
  • Specimens that have been frozen
  • Commingled specimens
  1. Specimens in tubes that have been damaged or broken during transport
  2. Specimens with insufficient volume for testing
  3. Unlabeled or mislabeled specimens

Storage/Transport Temperature

Transport Instructions      
Collection Location Transport Temperature Processing Required Timeframe
ED/Inpatient Room Temperature None Specimen must be received by the lab within 3 days of collection
Laboratory/Outpatient/Off-Site Room Temperature None Specimen must be received by the lab within 3 days of collection

Storage: Refrigerated

Stability (from collection to initiation)

Stability:
Prior to Extraction:
  • Room Temperature: 3 days
  • Refrigerated: 7 days
  • Frozen: Unacceptable
Extracted DNA:
  • Room Temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: Indefinitely

Laboratory Storage: 
  • Original Specimen: Refrigerated
  • Extracted DNA: Frozen
Laboratory Retention: 
  • Original Specimen: 1 month
  • Extracted DNA: 6 weeks

Collection Instructions

Labelling Instructions:
When labeling blood tubes, leave a small window visible for the lab to assess the fill volume and sample integrity. Ensure that the barcode is in the correct orientation.


Collection Instructions:
Follow the correct order of draw when collecting with additional orders and tube types:
     

Reference Interval

Not Detected: Negative for clonal rearrangement of the B cell receptor IGH or IGK genes

Interpretive Data

Positive results are highly suggestive of malignancy; however, a positive result should not be used as the sole criterion for diagnosis. Both positive and negative results should be interpreted in the context of all clinical and laboratory findings. False-negative results may occur in this assay due to somatic hypermutation of the rearranged Ig genes, preventing proper PCR primer binding. Thus, a negative result with this assay cannot be used to exclude a B-cell neoplasm.
 
B-Cell Clonality Interpretation
Result Interpretation
IGH Result = Not Detected
IGK Result = Not Detected
Result = Not Detected		 No clonal rearrangement of the B cell receptor IGH or IGK genes was detected.
IGH Result = Detected
IGK Result = Not Detected
Result = Detected		 A clonal rearrangement of the B cell receptor IGH gene was detected.
IGH Result = Not Detected
IGK Result = Detected
Result = Detected		 A clonal rearrangement of the B cell receptor IGK gene was detected.
IGH Result = Detected
IGK Result = Detected
Result = Detected		 A clonal rearrangement of both the B cell receptor IGH and IGK genes was detected.
Ordering

Performed

Monday - Friday

Methodology

Polymerase Chain Reaction / Capillary Electrophoresis

Reported

Routine: 5 - 7 days

Synonyms

  • IGH and IGK B Cell Clonality, Blood
  • Blood, IgH and IgK B-Cell Clonality
  • B-Cell Clonality, IgH and IgK
  • Clonality Assessment
  • Lymphoid Malignancies
  • Lymphoid Malignancy
  • B Lymphocytes
  • Clonal B Lymphocytes
  • Clonal B-cells
  • B-Cell Clonality Screening
  • Screening, B-Cell Clonality
  • Clinical Genomics

Performing Lab

Clinical Genomics

Turnaround Time

7 days

Add-on Eligibility

Yes, within 7 days of collection
*If DNA has been extracted previously for other Clinical Genomics tests, this is stored for 6 weeks and may qualify for add-on
Collection

Specimen Type

Blood

Specimen Volume

5 mL (Minimum: 1 mL)

Collection Container

EDTA Whole Blood Tube (Lavender Top Vacutainer)

Unacceptable Conditions

  1. Severely clotted or grossly hemolyzed specimens
  2. Specimens that have been improperly collected, stored, or transported
  • Specimens collected in preservatives other than EDTA
    • ACD tubes are accepted, but EDTA is preferred
    • Heparinized specimens are accepted, but not recommended
  • Serum or plasma
  • Specimens that have been frozen
  • Commingled specimens
  1. Specimens in tubes that have been damaged or broken during transport
  2. Specimens with insufficient volume for testing
  3. Unlabeled or mislabeled specimens

Storage/Transport Temperature

Transport Instructions      
Collection Location Transport Temperature Processing Required Timeframe
ED/Inpatient Room Temperature None Specimen must be received by the lab within 3 days of collection
Laboratory/Outpatient/Off-Site Room Temperature None Specimen must be received by the lab within 3 days of collection

Storage: Refrigerated

Stability (from collection to initiation)

Stability:
Prior to Extraction:
  • Room Temperature: 3 days
  • Refrigerated: 7 days
  • Frozen: Unacceptable
Extracted DNA:
  • Room Temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: Indefinitely

Laboratory Storage: 
  • Original Specimen: Refrigerated
  • Extracted DNA: Frozen
Laboratory Retention: 
  • Original Specimen: 1 month
  • Extracted DNA: 6 weeks

Collection Instructions

Labelling Instructions:
When labeling blood tubes, leave a small window visible for the lab to assess the fill volume and sample integrity. Ensure that the barcode is in the correct orientation.


Collection Instructions:
Follow the correct order of draw when collecting with additional orders and tube types:
     
Result Interpretation

Reference Interval

Not Detected: Negative for clonal rearrangement of the B cell receptor IGH or IGK genes

Interpretive Data

Positive results are highly suggestive of malignancy; however, a positive result should not be used as the sole criterion for diagnosis. Both positive and negative results should be interpreted in the context of all clinical and laboratory findings. False-negative results may occur in this assay due to somatic hypermutation of the rearranged Ig genes, preventing proper PCR primer binding. Thus, a negative result with this assay cannot be used to exclude a B-cell neoplasm.
 
B-Cell Clonality Interpretation
Result Interpretation
IGH Result = Not Detected
IGK Result = Not Detected
Result = Not Detected		 No clonal rearrangement of the B cell receptor IGH or IGK genes was detected.
IGH Result = Detected
IGK Result = Not Detected
Result = Detected		 A clonal rearrangement of the B cell receptor IGH gene was detected.
IGH Result = Not Detected
IGK Result = Detected
Result = Detected		 A clonal rearrangement of the B cell receptor IGK gene was detected.
IGH Result = Detected
IGK Result = Detected
Result = Detected		 A clonal rearrangement of both the B cell receptor IGH and IGK genes was detected.

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