| ABL Kinase Domain Mutation in CML, Cell-based | 16029X |
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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: This ABL kinase mutation assay may detect drug-resistant mutations before clinical relapse and identify candidate suitable for alternative therapy. |
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| Specimen Container: EDTA (lavender-top) |
| Preferred Specimen: 2.1 mL EDTA (lavender-top) bone marrow (whole blood is acceptable) (1 mL minimum) |
| Transport Temperaturer: Refrigerated, stable 3 days |
| Methodology: Real-Time Polymerase Chain Reaction; Nested Polymerase Chain Reaction, Sequencing |
| Reject Criteria: Grossly hemolyzed; Lipemic; Frozen samples; Clotted whole blood samples; Clotted bone marrow samples |
