Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

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


Geisinger Epic Procedure Code: LAB3448         Geisinger Epic ID: 60554

Specimen type:
Whole blood
Preferred collection container:
Alternate Collection Container:
3 mL lavender-top (K2 EDTA) tube
Specimen required:
TWO - 6 mL (minimum of 4 mL in each tube) whole blood.
Special notes:
Do not separate plasma from cells. Collect TWO 6 mL tubes or FOUR 3 mL tubes.

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

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 limit of quantitation (LoQ) for the BCR-ABL1 p210 assay is 0.003 %IS. The dynamic range of this assay facilitates the assessment of the 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 the e13a2 and e14a2 variant transcripts. The lower limit of detection (LLod) and lower limit of quantitation (LoQ) for the BCR-ABL1 p190 assay is 0.003 %ratio. Supporting procedural data for this assay lists the LLod as 0.0025 %ratio and LoQ as 0.0036 %ratio.
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:
This test screens for the BCR-ABL1 p210 fusion form (major breakpoint) and when necessary the BCR-ABL1 p190 fusion form (minor breakpoint). The results of the BCR-ABL1 p210 assay are first normalized against the reference gene ABL1 and subsequently results are converted to an International Scale (%IS). The results of the BCR-ABL1 p190 assay are reported in BCR-ABL1/ABL1 %ratio. This test does not detect the rare BCR-ABL1 micro (p230) fusion form. To therapeutically monitor previously known BCR-ABL1 positive patients, order BCR-ABL1 p210, Monitor, RT-qPCR Assay or BCR-ABL1 p190, Monitor, RT-qPCR Assay.
Polymerase Chain Reaction (PCR)
Reverse Transcription Polymerase Chain Reaction (RT-PCR)
BCR, ABL, BCR-ABL, BCR-ABL1, p190, p230, major breakpoint, minor breakpoint
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: 08/17/2020

Performing Locations

Geisinger Medical Center

Performing laboratory: Molecular Diagnostics
Technical Lead: Lisa Scicchitano
Frequency: Weekly, on Thursday
Performed stat? No
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