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BCR/ABL1, p210 Quantitative, Monitor
MessageSendout, Mayo test code: BCRAB
Test Code
LAB5210434
Alias/See Also
Acute lymphoblastic leukemia (ALL)
Acute myeloid leukemia (AML)
B lymphoblastic leukemia (B-ALL)
T lymphoblastic leukemia (T-ALL)
BCR-ABL1
BCR ABL
BCR/ABL
Chronic myelogenous leukemia (CML)
Philadelphia chromosome, Ph bone marrow/blood
t(9;22)
Tyrosine kinase inhibitor (TKI) therapy monitoring, PCR
BCRAB
Acute myeloid leukemia (AML)
B lymphoblastic leukemia (B-ALL)
T lymphoblastic leukemia (T-ALL)
BCR-ABL1
BCR ABL
BCR/ABL
Chronic myelogenous leukemia (CML)
Philadelphia chromosome, Ph bone marrow/blood
t(9;22)
Tyrosine kinase inhibitor (TKI) therapy monitoring, PCR
BCRAB
CPT Codes
81206
Preferred Specimen
Blood: 10 mL whole blood in a lavender EDTA tube
Bone marrow: 3 mL in a lavender EDTA tube
Bone marrow: 3 mL in a lavender EDTA tube
Minimum Volume
4 mL whole blood
1 mL bone marrow
1 mL bone marrow
Other Acceptable Specimens
Pink EDTA or yellow ACD tube
Instructions
1. Invert several times to mix blood/bone marrow.
2. Send specimen in original tube.
3. Label specimen as blood.
2. Send specimen in original tube.
3. Label specimen as blood.
Transport Container
Original container
Transport Temperature
Refrigerated
Specimen Stability
Refrigerated (preferred): 72 hours
Ambient: 72 hours
Ambient: 72 hours
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis: Reject
Methodology
Quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
FDA Status
Approved
Setup Schedule
Monday through Friday
Report Available
3-6 days
Limitations
This test detects only the e13/a2 and e14/a2 fusion forms, which code for the p210 protein. Other fusion forms are not detected, including those containing the BCR e1 exon, which codes for the p190 protein commonly found in acute lymphoblastic leukemia (ALL). If the patient is known to carry an e1/a2 (p190) fusion form, the test BA190 / BCR/ABL, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay should be used for monitoring.
This test should not be used to screen for BCR/ABL1 fusions at the time of diagnosis; if a diagnostic screen for BCR-ABL1 transcripts is desired, the test BADX / BCR/ABL1, Qualitative, Diagnostic Assay, which is designed to detect all reported common and rare BCR-ABL1 mRNA fusion variants, should be ordered for this purpose.
The precision of this assay at low BCR/ABL1 levels is more variable, such that inter-run variation can be as high as + or - 0.5 log. Only level changes above 0.5 log should be considered clinically significant. For example, if a result is given as 0.1% BCR/ABL1:ABL1, then any result between 0.05% and 0.5% should be considered essentially equivalent. If the results are being used to make major therapeutic decisions, significant changes during monitoring should be verified with a subsequent specimen.
In general, the results of this assay cannot be directly compared with results generated from other PCR assays, including identical assays performed in other laboratories. Monitoring should be performed using the same method and laboratory for each subsequent specimen.
The results of this assay cannot be directly compared with BCR/ABL1 results obtained using FISH technology. FISH measures DNA alleles and RT-PCR-based assays measure mRNA transcripts. Because a single fusion DNA allele can produce many mRNA transcripts, the values are not directly comparable and FISH results are not applicable to the IS or to disease monitoring.
Blood is the specimen of choice for monitoring CML patients. The majority of CML patients show similar BCR/ABL1 mRNA levels in blood and bone marrow drawn at the same time, although occasional, patients may exhibit a difference in concurrent blood and marrow levels for technical or biological reasons, requiring follow-up testing to resolve.
This test should not be used to screen for BCR/ABL1 fusions at the time of diagnosis; if a diagnostic screen for BCR-ABL1 transcripts is desired, the test BADX / BCR/ABL1, Qualitative, Diagnostic Assay, which is designed to detect all reported common and rare BCR-ABL1 mRNA fusion variants, should be ordered for this purpose.
The precision of this assay at low BCR/ABL1 levels is more variable, such that inter-run variation can be as high as + or - 0.5 log. Only level changes above 0.5 log should be considered clinically significant. For example, if a result is given as 0.1% BCR/ABL1:ABL1, then any result between 0.05% and 0.5% should be considered essentially equivalent. If the results are being used to make major therapeutic decisions, significant changes during monitoring should be verified with a subsequent specimen.
In general, the results of this assay cannot be directly compared with results generated from other PCR assays, including identical assays performed in other laboratories. Monitoring should be performed using the same method and laboratory for each subsequent specimen.
The results of this assay cannot be directly compared with BCR/ABL1 results obtained using FISH technology. FISH measures DNA alleles and RT-PCR-based assays measure mRNA transcripts. Because a single fusion DNA allele can produce many mRNA transcripts, the values are not directly comparable and FISH results are not applicable to the IS or to disease monitoring.
Blood is the specimen of choice for monitoring CML patients. The majority of CML patients show similar BCR/ABL1 mRNA levels in blood and bone marrow drawn at the same time, although occasional, patients may exhibit a difference in concurrent blood and marrow levels for technical or biological reasons, requiring follow-up testing to resolve.
Reference Range
Included with report
Clinical Significance
Monitoring response to therapy in patients with chronic myeloid leukemia who are known to have the e13/a2 or e14/a2 BCR/ABL1 fusion transcript forms
Performing Laboratory
Mayo Clinic Laboratories, Rochester, Minnesota
Additional Information
BCR/ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies
