Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  

BCR-ABL1 P190/P210, DIAGNOSTIC, RT-QPCR

ORDERING INFORMATION:
Geisinger Epic Procedure Code: LAB3448         Geisinger Epic ID: 60554

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: Two (2) 6 mL pink-top K2 EDTA tube (minimum 4 mL each; preferred) OR four (4) 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)).
For molecular testing, original tube is required.
Special notes:
Do not separate plasma from cells.

SPECIMEN PROCESSING
Specimen 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:
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. The p210 BCR-ABL1 fusion transcript e13a2 or e14a2 is not detected AND/OR Negative. The p190 BCR-ABL1 fusion transcript e1a2 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.  The p210 assay does not discriminate between e13a2 and e14a2 variant transcripts. The lower limit of detection (LLoD) and lower limit of quantitation (LoQ) for the BCR-ABL1 p190 assay is 0.0100% ratio.   Supporting procedural data for this assay lists the LLoD and LoQ as 0.0100% ratio.  For molecular testing, original tube is required.
CPT code(s):
81206 and/or 81207
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:
The BCR-ABL1 p210 test detects BCR-ABL1 fusion transcripts e13a2 (b2a2) and e14a2 (b3a2) but does not discriminate between the transcripts.  The results of the BCR-ABL1 p210 test are first normalized against the reference gene ABL1 and subsequently results are converted to an International Scale (%IS). The results of BCR-ABL1 p190 test are reported in BCR-ABL1/ABL1 %ratio.

This test does not detect the rare BCR-ABL1 micro (230) fusion form.

Methodology:
Polymerase Chain Reaction (PCR)
Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms:
BCR, ABL, BCR-ABL, BCR-ABL1, p190, p210, p230, major breakpoint, minor breakpoint
BCRABD
Clinical significance:
This quantitative test is appropriate to screen/detect the BCR-ABL1 p210 (major) fusion form and/or BCR-ABL1 p190 (minor) fusion form in patients suspicious for BCR-ABL1-positive hematopoietic neoplasms, particularly chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia.
Doctoral Director(s:)
Yi Ding MD, PhD    
Review Date: 09/02/2021

Performing Locations

Geisinger Medical Center

Performing laboratory: Molecular Diagnostics
Technical Lead: Ronnie Rovenolt, Becky Knock
Frequency: Monday, Wednesday and Friday
Performed STAT? No
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