BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies
Use
The test is used for the diagnostic workup of patients with high probability of BCR::ABL1-positive hematopoietic neoplasms, predominantly chronic myeloid/myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL). It helps in establishing the initial patient diagnostic baseline level to assess response to therapy in follow-up samples, as recommended by current National Comprehensive Cancer Network guidelines for chronic myeloid leukemia.
Special Instructions
Pertinent clinical history including if the patient has a diagnosis of chronic myeloid/myelogenous leukemia or other BCR/ABL1 positive neoplasm is required.
Limitations
This assay, while analytically sensitive for detecting common BCR::ABL1 mRNA transcripts, does not identify extremely rare BCR::ABL1 events involving other exons and is, therefore, not absolutely specific, though it is predicted to detect greater than 99.5% of BCR::ABL1 events. It compensates for situations such as partially degraded RNA quality or low cell number but is not intended for quantitative or monitoring purposes.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- In Process
- 31208-2
- 69047-9
Result Turnaround Time
7-10 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) or 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.
Storage Instructions
Refrigerated (preferred), 72 hours; Ambient, 72 hours
Causes for Rejection
Gross hemolysis; Moderately to severely clotted
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 72 hours |