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Test Directory » B-Cell Receptor IGK Gene Rearrangement, PCR

Test Directory B-Cell Receptor IGK Gene Rearrangement, PCR

B-Cell Receptor IGK Gene Rearrangement, PCR

Order Code: BCRIGK

Test Summary

This assay, which interrogates the immunoglobulin kappa light chain gene (IGK) by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of B-cell lymphoid neoplasms and in the identification of minimal residual disease or early recurrence in patients with a previous diagnosis of B-cell neoplasm. It can be used in association with the immunoglobulin heavy chain (IGH PCR assay test code 90362), since false-negative results can occur in up to 10-25% of B-cell malignancies with testing IGK only.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube • 8 unstained positively charged slides

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate • 4 slides • 1 block

Instructions

Do not reject specimens, send to laboratory for screening.

8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).

Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Fresh tissue: Frozen
All other specimens: Room temperature

Specimen Stability

Whole blood or Bone marrow aspirate
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
FFPE/Slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen

Limitations

N/A

Other Acceptable Specimens

Whole blood or bone marrow aspirate collected in a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh tissue • Tissues in formalin fixative or RPMI

Unacceptable Specimens

N/A

Order Code

BCRIGK

EPIC (Premier) Code

LAB5393

Includes

Test includes pathologist interpretation

CPT Code

81264
84999 (HCPCS: G0452)

Billing Code

670579
670580

CPT Statement

Methodology

Polymerase Chain Reaction (PCR) • Fragment Analysis

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 5 days