BCR/ABL1, Qualitative, Diagnostic Assay, Varies
Use
This test is vital for the diagnostic workup of patients likely to have BCR::ABL1-positive hematopoietic neoplasms, predominantly chronic myeloid leukemia and acute lymphoblastic leukemia. It detects both usual and uncommon BCR::ABL1 transcript variants and is a comprehensive screen for gene fusions in hematopoietic malignancies. The t(9;22)/BCR::ABL1 abnormality is mainly associated with chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia. The assay can guide further monitoring and therapeutic strategies.
Special Instructions
Refrigerate specimens must arrive within 5 days of collection, and ambient specimens within 72 hours. Collect and package specimens as close to shipping time as possible. Pertinent clinical history including diagnosis of chronic myelogenous leukemia or other BCR::ABL1-positive neoplasm is required.
Limitations
This assay is intended as a qualitative method, providing information on the presence or absence of the BCR::ABL1 mRNA and the specific mRNA type. It is not intended for quantitative or monitoring purposes. The assay is not absolutely specific for extremely rare and unexpected BCR::ABL1 events involving other exons, potentially identifying more than 99.5% of BCR::ABL1 events. Positive results need correlation with clinical and pathologic findings.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 55135-8
- 31208-2
- 69047-9
Result Turnaround Time
5-10 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
10 mL
Minimum Volume
8 mL
Container
Lavender top (EDTA), Yellow top (ACD)
Collection Instructions
Invert several times to mix blood. Send whole blood specimen in original tube. Do not aliquot. Label specimen as blood.
Causes for Rejection
Gross hemolysis, Moderately to severely clotted
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 5 days |