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BCR/ABL1, Major (p210), Quantitation

BCR Quantitation By RT-PCR, MRD, CML

Test Codes

EPIC: LAB7136, SOFT: G210G

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: 10 mL whole blood in Lavender-top EDTA. (Minimum: 5.0 mL)

A copy of the requisition must be sent with the specimen. 

Physician Office/Draw Specimen Preparation

Do not freeze specimens. Maintain whole blood at room temperature (20-26°C or 68-78.8°F), or refrigerate (2-8°C or 36-46°F) if the specimen will not be received in the laboratory within 6 hours of collection.

Preparation for Courier Transport

Transport: Maintain whole blood at room temperature (20-26°C or 68-78.8°F) or refrigerate (2-8°C or 36-46°F) if the specimen will not be received in the laboratory within 6 hours of collection. (Minimum: 5.0 mL)

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 within 7-14 days.

Reference Range

Not Detected (no gene rearrangement detected).

Test Methodology

RNA extraction from whole blood and BCR-ABL fusion transcript and quantitation analysis using real-time reverse transcriptase – polymerase chain reaction (RT-qPCR).

Interpretation

The BCR-ABL fusion transcript quantitation is normalized by calculating the relative ratio to normal ABL transcript. An IS-MMR calibrator is also run in the assay, allowing conversion of results to the international scale for accurate measurement of molecular response. The presence of detectable BCR-ABL transcript confirms the existence of persistent transcriptionally active CML (chronic myeloid leukemia) cells.

Clinical Utility

• This quantitative test is used for monitoring therapy response to tyrosine kinase inhibitors, by serial measurement of CML-specific transcripts (p210; b2a2, b3a2) as an accurate measure of the total leukemia-cell mass. 
  • This test can only be used if the patient is positive for the b2a2 or b3a2 major (p210) breakpoints.
  • Patient’s positive for alternate breakpoints will be sent to a reference lab.
• This test is intended for use ONLY on peripheral blood from patients with a previously diagnosed t(9:22) translocation.
• Peripheral blood specimens from patients with unconfirmed cases of CML or Ph+ ALL should be submitted for BCR/ABL1 Gene Rearrangement testing. 

CPT Codes

81206
LOINC:  55135-8

Contacts

Last Updated

7/16/2021