Diagnostic Qualitative BCR-ABL1 Assay with Reflex to p190 or p210 Quantitative Assays
This qualitative screening test is appropriate for initial diagnosis of chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL). Use to detect the presence of p210 (major breakpoint), p190 (minor breakpoint), and p230 (micro breakpoint) fusions. If a common p210 or p190 BCR-ABL1 fusion transcript is detected, the appropriate test will be added to provide a quantitative value, which may be used as the diagnostic baseline to further monitor treatment response.
For patients with a known history of p210 or p190 fusion transcripts, refer to Quantitative Detection of BCR-ABL1, Major Form (p210) (3005840) or BCR-ABL1, Minor (p190), Quantitative (2005016). These two tests are the appropriate tests to monitor therapeutic response and to detect minimal residual disease (MRD). Low-level residual disease might not be detected by inappropriate use of this screening/diagnostic assay.
Reverse Transcription Polymerase Chain Reaction
RNA isolation: Sun-Sat
If reflexed: TAT may be extended by 3-7 days
New York DOH Approval Status
Whole blood or bone marrow in lavender (EDTA).
Whole blood: Transport 5 mL whole blood. (Min: 3 mL)
Bone marrow: Transport 3 mL bone marrow. (Min: 1 mL)
Refrigerate immediately. Specimens must be received within 48 hours of collection due to lability of RNA.
Whole blood and bone marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.
Serum, plasma, ambient or frozen bone marrow or whole blood, CSF, or FFPE tissue. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed or clotted specimens.
Ambient whole blood and ambient bone marrow specimens past 7 days will be canceled. Refrigerated whole blood or bone marrow past 7 days will be canceled.
This qualitative test is intended as a screening test only for initial diagnosis. For those patients with an established diagnosis, please order 3005840 Quantitative Detection of BCR-ABL1, Major Form (p210) or (ARUP Test code 2005016) BCR-ABL1, Minor (p190), Quantitative.
Ambient: Unacceptable; Refrigerated: 48 hours; Frozen: Unacceptable
Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
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 common 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 Quantitative Detection of BCR-ABL1, Major Form (p210) (ARUP test code 3005840) 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|
|3005851||Diagnostic Qual BCR-ABL1 Assay, Source||31208-2|
|3005852||Diagnostic Qual BCR-ABL1 Assay, Result||21821-4|
- CML qualitative RT-PCR
- p210, p190 and p230
- Philadelphia chromosome bone marrow/blood
- t(9;22) by qualitative RT-PCR