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Specimen Collection Manual and Test Catalog

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BCR-ABL1 P210, MONITOR, RT-QPCR

Geisinger Epic Procedure Code:  LAB3446    Geisinger Epic ID:  60552

SPECIMEN COLLECTION
Specimen type:  Whole blood or bone marrow
Preferred collection container: 
Alternate collection container: 
3 mL lavender-top (K2 EDTA) tube
Specimen required: 
Whole blood: One (1) 6 mL pink-top K2 EDTA tube; minimum 4 mL; (preferred); OR two (2) 3 mL lavender-top K2 EDTA tubes (also acceptable).
Bone marrow: One (1) 3 mL lavender-top K2 EDTA tube (part of Bone Marrow Panel Collection – Bone Marrow Aspirate: Two (2) K2 EDTA tube(s)).
Special notes: 
For molecular testing, original tube(s) required.

SPECIMEN PROCESSING
Processing instructions: 
Mix well immediately. Send/deliver collection tube to GMC Molecular Diagnostics Laboratory. Store at 2-8°C. Do not centrifuge.
Transport temperature: 
Refrigerated, 2-8°C.
Specimen stability: 
Specimen stability: Refrigerated, 2-8°C: 3 days. Specimen must be tested within 3 days. If needed, specimens must be extracted within 3 days for RNA.
Rejection criteria: 
Wrong collection tube. Improper storage or transport temperature. Stability limits exceeded. Shared or comingled specimens.

TEST DETAILS
Reference interval: 
Negative. TheBCR-ABL1 p210 fusion transcript (e13a2 or e14a2) is not detected.
Additional information: 
The lower limit of detection (LLoD) and lower limit of quantitation (LoQ) for the BCR-ABL1 p210 assay is 0.0030% IS.  The dynamic range of this assay facilitates the assessment of major molecular response (MMR; 3 log reduction) and complete molecular response (CMR; 4.5 log reduction). Supporting procedural data for this assay lists the LLoD and LoQ for fusion transcript e13a2 (b2a2) as 0.0030% IS and e14a2 (b3a2) as 0.0029% IS, respectively.  This test does not discriminate between e14a2 and e13a2 variant transcripts. For molecular testing, original tube is required.
CPT code(s):  81206
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 
This test detects BCR-ABL1 fusion transcripts e13a2 (b2a2) and e14a2 (b3a2) but does not discriminate between the transcripts. The results of this test are first normalized against the reference gene ABL1 and subsequently results are converted to an International Scale (%IS).

This test does not detect the rare BCR-ABL1 micro (p230) fusion form. For the p190 fusion form (minor breakpoint), order BCR-ABL1, p190, Monitor, RT-qPCR Assay.

Methodology: 
Polymerase Chain Reaction (PCR)
Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms: 
BCR, ABL, BCR-ABL, BCR-ABL1, BA210M, p210
Clinical significance: 
This quantitative test is appropriate for therapeutic monitoring for CML or ALL. BCR-ABL1 major (p210) fusion forms are present in almost all cases of CML and in a small subset of cases of ALL.
Doctoral Director(s): 
Yi Ding MD, PhD
Review Date:  09/24/2024

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