BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative
Also known as: Acute Lymphocytic Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative, Chronic Myelogenous Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative, Quantitative BCR-ABL1 Translocation Detection by RT-PCR for CML and ALL
Use
This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:e13a2 (previously b2a2) and e14a2 (previously b3a2) (major breakpoint, p210), as well as e1a2 (minor breakpoint, p190). The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results should be correlated with appropriate clinical and laboratory information as indicated.
Special Instructions
Questions regarding this test can be directed to oncology customer service at 800-345-4363.
Limitations
The analytical detection sensitivity for this assay is 4.5 log below the standard baseline (<0.0032%). A negative result does not conclusively rule out low BCR-ABL1 transcript levels or rare transcripts not detected by this test. This assay was developed by Labcorp and has not been FDA-approved, potentially limiting its use or interpretation in some settings.
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 52135-1
- 52130-2
- 52131-0
- 52132-8
- 93479-4
- 72486-4
- 77202-0
- 49549-9
- 80563-0
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
3 to 5 mL
Minimum Volume
3 mL
Container
Lavender-top (EDTA) tube, green-top (sodium heparin) tube, yellow-top (ACD-A) tube, tan-top (K2-EDTA) tube or pink-top (K2-EDTA) tube
Collection Instructions
Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on test request form.
Storage Instructions
Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
Causes for Rejection
Specimen does not meet collection criteria; frozen whole blood; leaking tube; clotted blood; grossly hemolyzed; visibly degraded; contamination by another specimen; containing foreign material