BCR/ABL - t(9;22) by RT-PCR (Quantitative)
Also known as: MRDx BCR-ABL Test
Use
This test detects varying levels of BCR-ABL1 fusion transcripts associated with Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), and Acute Myelocytic Leukemia (AML). It can identify different types of BCR-ABL1 fusion transcripts including e13a2, e14a2, and e1a2, which are titrated to the current International Scale (IS). The test is particularly useful in monitoring patients with these hematologic malignancies, providing a quantitative measure of the BCR-ABL1/ABL1 ratio, which is critical for tracking the response to treatment and disease progression. Results should be correlated with other clinical and laboratory data for comprehensive assessment.
Special Instructions
Not provided.
Limitations
This assay has an analytical detection sensitivity of 4.5 log below the standard baseline (<0.0032%), meaning it may not detect low levels of BCR-ABL1 transcript that are below this threshold. It is also unable to detect rare BCR-ABL1 transcripts not included in the panel. The test has been developed and validated by Labcorp but has not been cleared or approved by the FDA.
Methodology
PCR-based (RT-PCR)
Biomarkers
BCR-ABL1 e13a2 fusion
FusionBCR-ABL1 e14a2 fusion
FusionBCR-ABL1 e1a2 fusion
Fusion
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 or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed; otherwise visibly degraded; contamination by another specimen; containing suspicious foreign material
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