BCR-ABL1 RT-qPCR Minor p190 Quant
BCR-ABL1 PCR Screen; BCR-ABL1 Minor Breakpoint; p190 fusion transcript; CML
- Tech Only CPT
- Tech Pro CPT
- PowerPath Code BCR-ABL p190
- Schedule Monday - Friday (Variable)
- Turn Around Time 4-7 days
- Disease State Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML)
- Methodology Reverse-Transcriptase and real-time (RT-qPCR) polymerase chain reaction to measure the quantity of BCR-ABL1 fusion transcript p190 (e1a2)
Organs
Specimen Requirements
Minimum of 1 mL whole blood in a purple (EDTA) or pink top tube (EDTA);
Minimum of 1 mL of bone marrow aspirate in a purple, pink, or green (heparin) top tube.
Diagnostic Utility
Presence of the BCR-ABL1 fusion transcript is seen in a majority of patients with CML, and in a subset of patients of B-ALL. Quantitative monitoring of the BCR-ABL1 transcript can act as a diagnostic tool and provide guidance during therapy.
Clinical Significance
Monitoring therapy in patients with CML or other BCR-ABL1 positive neoplasms with known ela2 fusion transcript. The transcript level for the minor breakpoint (p190) is reported as the NCN% ratio of BCR-ABL1 to ABL1.
Required Patient Info
If patient has had BCR ABL testing previously please provide results, date and performing laboratory information.
Storage and Transportation
Refrigerated; specimens must be delivered to the lab within 72-hours of collection
Cause for Rejection
Frozen specimen; clotted or grossly hemolyzed specimens; serum; specimens without 2 patient identifiers; serum or plasma, aliquots (previously open containers); bone marrow cores (fresh or FFPE); collection date >72-hours from receipt and RNA has shown signs of significant degradation.
Retention
One week - whole blood or bone marrow; RNA - 2 years
Comments
This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.