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BCR/ABL Gene Rearrangement Test

BCR/ABL Qualitative Test, BCR-ABL Gene Rearrangement Test, BCR ABL Gene Rearrangement Test, CML, t(9;22), chronic myelogenous leukemia, ALL, acute lymphoblastic leukemia, major, minor, breakpoint

Test Codes

EPIC: LAB6378, SOFT: GBCRG

Department

Molecular Pathology

Instructions

Samples should be drawn as early in the day as possible so they can be delivered to the Laboratory the same day.

Specimen Collection Criteria

Collect: Blood OR Bone Marrow

• Blood: 10 mL whole blood in Lavender-top EDTA tubes. (Minimum: 5.0 mL)
• Bone Marrow: 1.0 mL bone marrow aspirate in a Lavender-top EDTA tube. (Minimum: 0.5 mL)
• Other specimen types require the approval of the Medical or Technical Director.

Physician Office/Draw Specimen Preparation

Do not freeze specimens. Maintain specimens at room temperature (20-26°C or 68-78.8°F) and transport to the Laboratory within 4-6 hours of collection.  

Preparation for Courier Transport

Transport: Whole blood or bone marrow aspirate at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

• Frozen specimens. 
• Unlabeled tubes. 
• Specimens collected in heparin (Green-top), clot tubes (Red-top) ACD anti-coagulant tubes, or SST tubes.     

In-Lab Processing

Do not freeze specimens. Maintain specimen refrigerated (2-8°C or 36-46°F) prior to testing. 

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 6 hours
Refrigerated (2-8°C or 36-46°F): 48 hours
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory

Performed

Once per week.
Results available in 7–10 days.

Reference Range

Negative (no gene rearrangement).

Test Methodology

RNA extraction and analysis for BCR-ABL fusion transcript from whole blood or bone marrow using the reverse transcriptase and the polymerase chain reaction (RT-PCR) followed by restriction fragment length analysis.

Interpretation

The test is diagnostic for chronic myeloid leukemia (CML) and is a prognostic indicator in acute lymphoblastic leukemia (ALL) in the adult and pediatric ALL cases.

Clinical Utility

• This test is used for the detection of BCR-ABL gene rearrangement for the diagnosis and monitoring of CML and ALL patients.
• The test is required for the diagnosis of CML, also to rule out CML in all other myeloproliferative neoplasms; for ALL patients, both pediatric and adults, the test is recommended for risk stratification.
• Breakpoints Identified: Minor (p190) - e1a2
                                         Major (p210) - b3a2, b3a3, b2a2

CPT Codes

81206, 81207.
LOINC: Major Breakpoint (p210), Minor Breakpoint (p190) - 21821-4

Contacts

Last Updated

6/17/2021