Diagnostic Qualitative BCR::ABL1 Assay with Reflex to p190 or p210 Quantitative Assays

Also known as: DX BCR RFX

Clinical Use

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

Not provided.

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.

Test Details

New York Approved

Methodology

PCR-based (RT-PCR)

Biomarkers

BCR-ABL1 fusion

Fusion

p210, p190, and p230

Other • Binary (Detected / Not Detected)

LOINC Codes

Order Codes

31208-2 - Specimen source

Result Codes

21821-4 - t(9;22)(ABL1,BCR) Bld/T Ql

Result Turnaround Time

4-10 days

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.