| ABL Kinase Domain Mutation in CML, Plasma-based, Leumeta™ | 16031X |
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| This test was developed and its performance characteristics have been determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test. | ||
| CPT Code(s): 83891; 83894; 83902; 83898 (x6); 83909; 83904; 83912 | Clinical Significance: Chronic myelogeneous leukemia (CML) is a hematopoietic stem cell disorder, the result of a (9;22) translocation that produces the constitutively active, BCR-ABL tyrosine kinase. Mutations within the BCR-ABL kinase domain are the most commonly identified mechanism associated with relapse. Specific amino acid substitutions lead to drug resistance. |
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| Specimen Container: EDTA (lavender-top) |
| Preferred Specimen: 3 mL EDTA whole blood |
| Instructions: NOTE: Information regarding draw time and date is required to ensure stability of the sample is maintained. Submission of whole blood is preferred. To avoid contamination, the laboratory will separate the plasma upon arrival. Follow standard whole blood collection procedure. Collect 3-5 mL whole blood samples in an EDTA tube. Blood samples are shipped at RT or 4ºC. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability. Submission of plasma is acceptable. Collect blood in sterile tubes containing EDTA anticoagulant (lavender-top). Separate plasma from the cells by centrifugation, transfer the plasma to a separate plastic screw-cap vial, and ship frozen. |
| Transport Temperaturer: Refrigerated, stable 72 hours |
| Methodology: Reverse Transcriptase Polymerase Chain Reaction, Nested PCR, Sequencing |
