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BCR-ABL1 Major (p210) by Quantitative RT-PCR with Reflex to Minor (p190) for Baseline Quantitation : 1016500
Test CodeMDFCPBCRABLQPMM or 1016500
Alias/See Also
Philadelphia Chromosome Ph1 Bone Blood; t(9;22) p210 detection; BCR/ABL; BCR/ABL1; CML; p190
CPT Codes
81206
Includes
The BCR-ABL1 Minor (p190) reflex assay will be performed, at an additional charge, if the patient has a result of “not detected” for the BCR-ABL1 Major (p210) transcript and does not have a history of previous positive Major (p210) results from our laboratory.
Instructions
Peripheral Blood in a lavender top tube (EDTA).
Transport Container
Submit 5-10 mL Blood (Min. 5 mL) : Do not centrifuge.
Transport Temperature
Refrigerated.
Specimen Stability
Ambient: 1 hour; Refrigerated: 72 hours; Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples submitted in Sodium Heparin.
Methodology
Reverse Transcription-Quantitative Polymerase Chain Reaction (RT-qPCR)
Setup Schedule
p210: Monday - Friday
If reflexed to p190: Monday & Thursday
If reflexed to p190: Monday & Thursday
Report Available
p210: 2-5 days
p190: 4-6 days after reflex added
p190: 4-6 days after reflex added
Limitations
This assay has been validated for whole blood collected in EDTA tubes. It has not been validated for use with bone marrow samples. This assay is only designed to detect the BCR-ABL1 fusion transcripts e13a2, e14a2 and e1a2. The test does not detect other rare fusion transcripts resulting from t(9:22), micro breakpoints, microdeletions, or mutations. Low RNA quality and/or quantity can greatly affect the results of this assay, which may lead to software errors and/or misquantification. The lower limit of quantification for the BCR-ABL1 Major (p210) assay is MR4.7 or 0.002% IS. The lower limit of quantification for the BCR-ABL1 Minor (p190) assay is 0.036%. Some patients with very low levels of BCR-ABL1 transcript below these limits of quantification may be reported as not detected. Hence, a not detected result does not preclude the presence of low levels of leukemic cells in the patient.
p210: FDA approved.
p190: Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
p210: FDA approved.
p190: Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Reference Range
An interpretive report will be provided.
Clinical Significance
This reflex test is intended to aid in breakpoint determination and baseline quantitation for patients with newly diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL). The BCR-ABL1 Major (p210) assay will detect the BCR-ABL Major (p210) fusion transcript (i.e. transcript types e13a2 and e14a2). The BCR-ABL1 Minor (p190) assay will detect the BCR-ABL1 Minor (p190) fusion transcript (i.e. transcript type e1a2). These tests will not detect other rare fusion transcripts resulting from t(9:22). These tests are not intended for the diagnosis of CML or ALL.
The BCR-ABL1 Minor (p190) reflex assay will be performed only if the patient has a result of “not detected” for the BCR-ABL1 Major (p210) transcript and does not have a history of previous positive Major (p210) results from our laboratory.
The BCR-ABL1 Major (p210) assay utilizes the FDA-cleared QuantideX qPCR BCR-ABL IS Kit, an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive patients. The test does not differentiate between e13a2 or e14a2 fusion transcripts.
The BCR-ABL1 Minor (p190) assay is performed by reverse transcription-quantitative PCR (RT-qPCR) to measure the quantity of BCR-ABL1 Minor (p190) fusion transcripts. Amplification of endogenous ABL1 is assessed as a reference for relative quantification and RNA quality. The normalized copy number (NCN) is derived by comparing the amount of BCR-ABL1 mRNA normalized to ABL1 and is reported as a percentage. Reporting on the International Scale (IS) is not available for the BCR-ABL1 Minor (p190) fusion transcript.
The BCR-ABL1 Minor (p190) reflex assay will be performed only if the patient has a result of “not detected” for the BCR-ABL1 Major (p210) transcript and does not have a history of previous positive Major (p210) results from our laboratory.
The BCR-ABL1 Major (p210) assay utilizes the FDA-cleared QuantideX qPCR BCR-ABL IS Kit, an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive patients. The test does not differentiate between e13a2 or e14a2 fusion transcripts.
The BCR-ABL1 Minor (p190) assay is performed by reverse transcription-quantitative PCR (RT-qPCR) to measure the quantity of BCR-ABL1 Minor (p190) fusion transcripts. Amplification of endogenous ABL1 is assessed as a reference for relative quantification and RNA quality. The normalized copy number (NCN) is derived by comparing the amount of BCR-ABL1 mRNA normalized to ABL1 and is reported as a percentage. Reporting on the International Scale (IS) is not available for the BCR-ABL1 Minor (p190) fusion transcript.
Performing Laboratory
med fusion
