For use in detecting the presence of a BCR-ABL1 fusion, for determining breakpoint status, and for baseline quantitation.
Reverse Transcription Polymerase Chain Reaction
RNA isolation: Sun-Sat
Lavender (EDTA) or bone marrow (EDTA). Sodium Heparin Whole Blood or Bone Marrow. Also acceptable: RNA extracted by CLIA certified lab.
Whole Blood: Transport 5 mL whole blood. (Min: 4 mL)
Bone Marrow: Transport 3 mL bone marrow. (Min: 1 mL)
Specimens must be received within 48 hours of collection due to lability of RNA.
Extracted RNA: Transport 40 uL RNA with at least 40 ng/uL concentration. (Min: 40 uL) Transport RNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Whole Blood or Bone Marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.
Extracted RNA: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered.
Serum, plasma, CSF, extracted DNA, RNA extracted by a non-CLIA lab, bone core, or FFPE tissue. Specimens collected in anticoagulants other than indicated. Severely hemolyzed or clotted specimens.
Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable
Extracted RNA: Ambient: Unacceptable; Refrigerate: Unacceptable; Frozen: Indefinitely
Refer to report.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
This reflex assay is recommended when the BCR-ABL1 fusion form is not known or unclear. This reflex assay detects the presence of either the p210 (major breakpoint), p190 (minor breakpoint), or p230 (micro breakpoint). If the presence of either the p210 or p190 BCR-ABL1 fusion is detected, then the appropriate quantitative test will be performed. Additional charges apply.
If the fusion form is known, refer to BCR-ABL1, Major (p210), Quantitative (ARUP test code 2005017) or BCR-ABL1, Minor (p190), Quantitative (ARUP test code 2005016).
81206; 81207; 81208; If reflexed, add 81206 or 81207
|Component Test Code*||Component Chart Name||LOINC|
|0055553||BCR-ABL1, t(9;22) Qual by RT-PCR||21821-4|
- philadelphia chromosome
- Philadelphia MS