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HelpTest Code LAB3353 BCR/ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies
Reporting Name
BCR/ABL1, p210, Quant, MonitorUseful For
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 in Rochester
Specimen Type
VariesShipping Instructions
Specimen must arrive within 72 hours of collection. Collect and package specimen as close to shipping time as possible. Specimens greater than 3 days old at the time of receipt will be considered unacceptable.
Necessary Information
Pertinent clinical history including if the patient has a diagnosis of chronic myeloid leukemia or other BCR/ABL1-positive neoplasm information is required.
Specimen Required
Submit only 1 of the following specimens:
Specimen Type: Whole blood
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
Specimen Volume: 10 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
3. Label specimen as blood.
Specimen Type: Bone marrow
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send bone marrow specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Specimen Minimum Volume
Blood: 4 mL
Bone marrow: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | 72 hours | PURPLE OR PINK TOP/EDTA |
| Ambient | 72 hours | PURPLE OR PINK TOP/EDTA |
Special Instructions
Reference Values
The presence or absence of BCR/ABL1 mRNA fusion form e13/e14-a2 producing the p210 fusion protein is identified. If positive, the quantitative level is reported as the normalized ratio of BCR/ABL1 (p210) to endogenous ABL1 mRNA with conversion to a percentage referenced to the international scale (IS), on which 0.1% BCR/ABL1:ABL1 (also represented on a log scale as Molecular Response 3, or MR3) is designated as a major molecular response (MMR) threshold.
Day(s) Performed
Monday through Saturday
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81206
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| BCRAB | BCR/ABL1, p210, Quant, Monitor | 55135-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 48411 | BCR/ABL1, p210 Result | 55135-8 |
| MP003 | Specimen Type | 31208-2 |
| 19598 | Final Diagnosis: | 34574-4 |
Cautions
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, Varies 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, Varies 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 polymerase chain reaction (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.
Report Available
3 to 6 daysReject Due To
| Gross hemolysis | Reject |
| Moderately to severely clotted | Reject |
NY State Approved
YesMethod Name
Quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Secondary ID
89007Forms
1. Hematopathology Patient Information (T676)
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Testing Algorithm
For information see BCR/ABL1 Ordering Guide for Blood and Bone Marrow.