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BCR ABL1, Major (p210), Quantitation

BCR Quantitation by RT-PCR, MRD, CML

Test Codes

EPIC: LAB7136, Beaker: G210G

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: 10 mL whole blood in Lavender-top EDTA. (Minimum: 4.0 mL)

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 (preferred) (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 (preferred) (2-8°C or 36-46°F) if the specimen will not be received in the laboratory within 6 hours of collection. (Minimum: 4.0 mL)

Rejection Criteria

• Frozen specimens.
• Centrifuged specimens.
• Mislabeled or unlabeled tubes.
• Specimens collected in heparin tubes (Green-top), clot tubes (Red-top), ACD anti-coagulant tubes, or SST tubes.
• Specimens not collected and processed as indicated.

Client will be notified of any cancellation of testing.

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:

N/A - entire specimen extracted for RNA upon arrival in the Molecular Laboratory. 

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

Once per week.
Results available within 7-14 days.

Reference Range

<0.0020 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 ABL1 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 ABL1 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; e13a2 (b2a2) and e14a2 (b3a2)) as an accurate measure of the total leukemia-cell mass. 
  • This test can only be used if the patient is positive for the e13a2 (b2a2) or e14a2 (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 BCR ABL1 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

Contacts

Last Updated

10/30/2023