Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Test Name: Sunquest Test Code Epic Procedure Code Or ID CPT Code:  

BCR-ABL1 P210, MONITOR, RT-QPCR

ORDERING INFORMATION:
Sunquest Test Code:
BA210M      Geisinger Epic Procedure Code: BA210M         Geisinger Epic ID: 60552

SPECIMEN COLLECTION
Specimen type:
Whole blood
Preferred collection container:
Alternate Collection Container:
3 mL lavender-top (K2 EDTA) tube
Specimen required:
6 mL (minimum 4 mL) whole blood. If using 3 mL tubes, collect two (2) tubes.
Special notes:
Do not separate plasma from cells.

SPECIMEN PROCESSING
Transport temperature:
Refrigerated, 2-8°C.
Specimen stability:
Refrigerated, 2-8°C: 3 days. Specimen must be tested within 3 days.
Rejection criteria:
Wrong collection tube. Improper storage or transport temperature. Stablility limits exceeded. Shared or comingled specimens.

TEST DETAILS
Reference interval:
Negative. The p210 BCR-ABL1 fusion transcript (e13a2 or e14a2) is not detected.
Additional information:
The lower limit of detection (LLoD) and limit of quantitation (LoQ) for the assay is 0.003 %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 0.01 %IS and e14a2 (b3a2) as 0.003 %IS, respectively. This test does not discriminate between the e14a2 and e13a2 variant transcripts.
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 referene 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
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: 09/11/2019

Performing Locations

Geisinger Medical Center

Performing laboratory: Molecular Diagnostics
Technical Lead: Lisa Scicchitano
Frequency: Twice weekly on Tuesday and Thursday
Performed stat? No
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