Diagnostic Qualitative BCR::ABL1 Assay with Reflex to p190 or p210 Quantitative Assays
Also known as: DX BCR RFX
Use
This qualitative screening test is intended for the initial diagnosis of chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL). It detects the presence of BCR::ABL1 fusion transcripts at the major (p210), minor (p190), and micro (p230) breakpoints, helping to establish a diagnostic baseline for monitoring treatment response. If p210 or p190 fusion transcripts are detected, a quantitative test is added, providing a measurable baseline to observe treatment progress.
Special Instructions
This test is a reflex assay and is recommended when the form of BCR::ABL1 fusion is unclear. If the fusion form is known, quantitative detection tests specific to p210 or p190 should be used instead. The test is New York state approved and requires informed consent for genetic testing for patients in NY.
Limitations
The assay is not intended for therapeutic monitoring or detecting minimal residual disease (MRD). Rare BCR::ABL1 fusions with alternative breakpoints not involving ABL1 exon 2 will not be detected. Furthermore, low-level fusion transcripts suggesting MRD may not be identified using this test, and test results should be interpreted in conjunction with clinical data for a comprehensive diagnosis.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 31208-2
- 21821-4
Result Turnaround Time
4-10 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
5 mL
Minimum Volume
3 mL
Container
lavender (EDTA)
Storage Instructions
Refrigerate immediately. Specimens must be received within 48 hours of collection due to lability of RNA.
Causes for Rejection
Serum, plasma, extracted DNA, CSF, FFPE tissue, ambient whole blood, or frozen whole blood. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed or clotted specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | 48 hours |
| Frozen | Unacceptable |