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BCR-ABL PCR, Quantitative
MessageNOTE:SPECIMEN MUST ARRIVE AT REFERENCE LAB WITHIN 48 HRS OF COLLECTION.
*Collect specimen Monday through Friday only before 1500 EST. Do not collect the day before a holiday.
*Collect specimen Monday through Friday only before 1500 EST. Do not collect the day before a holiday.
Test Code
LAB00474
Alias/See Also
LAB00474
LabCorp TC: 480481
LabCorp Test Name: BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative
Quantitative BCR-ABL1 Translocation Detection by RT-PCR for CML and ALL
LabCorp TC: 480481
LabCorp Test Name: BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative
Quantitative BCR-ABL1 Translocation Detection by RT-PCR for CML and ALL
CPT Codes
81206,81207
Preferred Specimen
5 mL Lavender (EDTA) - Whole Blood
Minimum Volume
3 mL Lavender (EDTA) - Whole Blood
Other Acceptable Specimens
Dark Green Top (Sodium Heparin) - Whole Blood
Yellow Top (ACD) - Whole Blood
1 mL Bone Marrow
Yellow Top (ACD) - Whole Blood
1 mL Bone Marrow
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.
Transport Temperature
Room Temperature
Specimen Stability
Room Temperature: 48 hours
If specimen has to be stored more than 48 hours, refrigerate at 2℃ to 8℃.
If specimen has to be stored more than 48 hours, refrigerate at 2℃ to 8℃.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Speicmen 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.
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Report Available
5-7 days
Limitations
In vitro studies have indicated that this assay has an analytical detection sensitivity of 4.5 log below the standard baseline (<0.0032%). A negative result does not rule out the presence of low levels of BRC-ABL1 transcript below the level of detection of this assay, or the presence of rare BCR-ABL1 transcripts not detected by the assay.
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.
Clinical Significance
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 adn e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular resonse (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results shoud be correlated with appropriate clinical and laboratory information as indicated.
Performing Laboratory
LabCorp