B-Cell Clonality Screening (IgH and IgK) by PCR

2006193
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Additional Technical Information

Ordering Recommendation

Aid in diagnosis and monitoring of B-cell lymphoproliferative disorders and in differentiating malignant from reactive lymphoid proliferations.

Mnemonic

BCELL SCRN

Methodology

Capillary Electrophoresis

Performed

DNA isolation: Sun-Sat; Assay: Varies

Reported

5-7 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Whole blood or bone marrow (EDTA), tissue, formalin-fixed tissue.

Specimen Preparation

Whole Blood: Do not freeze. Transport 5 mL whole blood. (Min: 1 mL)
Bone Marrow: Do not freeze. Transport 3 mL bone marrow. (Min: 1 mL)
Fresh Tissue: Freeze immediately. Transport 100 mg or 0.5-2.0 cm3 tissue.
FFPE Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Tissue block will be returned after testing. Transport tissue block or four 10-micron shavings in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.

Storage/Transport Temperature

Whole Blood, Bone Marrow: Refrigerated.
Fresh Tissue: Frozen on dry ice.
FFPE Tumor Tissue: Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months

Unacceptable Conditions

Plasma, serum. Specimens collected in anticoagulants other than EDTA. Clotted or grossly hemolyzed specimens.
Tissue: Specimens fixed/processed in alternative fixatives, heavy metal fixatives (B-4 or B-5), or tissue sections on slides. Decalcified specimens.

Remarks

If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

Stability

Whole Blood or Bone Marrow: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable
Fresh Tissue: Ambient: Unacceptable; Refrigerated: 2 hours; Frozen: 1 year
FFPE Tumor Tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerate: Indefinitely; Frozen: Indefinitely

Reference Interval

Interpretive Data

Refer to report.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
02/23/2022
X
N/A

CPT Codes

81261; 81264

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Components

Component Test Code* Component Chart Name LOINC
2006287 B-Cell Clonality, Source 31208-2
2006288 B-Cell Clonality, IgH and IgK by PCR
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • B-cell clonality screening
  • IgH and IgK B-cell clonality
B-Cell Clonality Screening (IgH and IgK) by PCR