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Time Sensitive

Ordering Recommendation

Aids in the diagnosis and monitoring of B-cell lymphoproliferative disorders. This is an ancillary test that may be used in the context of additional morphologic and clinical evaluation to differentiate between malignant and reactive proliferations. This test uses primers from the BIOMED-2 primer set that target IgH (VHFR1-JH; VHFR2-JH; VHFR3-JH) and IgK (VK-JK; VK-Kde; JKCK intron-Kde) genes.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Whole blood or bone marrow in lavender (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 fixed (10 percent neutral buffered formalin) and paraffin embedded 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: FFPE specimens fixed/processed in any fixative other than 10 percent neutral buffered formalin. 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: Refrigerated: 7 days; Frozen: Unacceptable
Fresh Tissue: Ambient: Unacceptable; Refrigerated: 2 hours; Frozen: 1 year
FFPE Tumor Tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Methodology

Capillary Electrophoresis/Polymerase Chain Reaction (PCR)

Performed

Varies

Reported

5-9 days

Reference Interval

Interpretive Data

Refer to report.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

81261; 81264

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