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HelpTest Code BCRAB 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 e13/a2 or e14/a2 BCR::ABL1 fusion transcript forms
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
VariesOrdering Guidance
This test is intended for monitoring patients with known e13/a2 or e14/a2 BCR::ABL1 (p210) fusion forms.
This test should not be used to screen for BCR::ABL1 fusions at the time of diagnosis.
To screen for BCR::ABL1 fusions at the time of diagnosis, order one of the following:
-BADX / BCR::ABL1, Qualitative, Diagnostic Assay, Varies
-BCRFX / BCR::ABL1 Qualitative Diagnostic Assay with Reflex to BCR::ABL1 p190 Quantitative Assay or BCR::ABL1 p210 Quantitative Assay, Varies .
To monitor patients carrying BCR::ABL1 fusion forms coding for the p190 (e1/a2) protein, order BA190 / BCR::ABL1, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies.
To monitor patients carrying rare BCR::ABL1 fusion forms coding for e19a2, e13/e14a3, e1a3, e6a2, e19a3, e8a2, e12a2, e6a3, e8a3, and e12a3, order BARQ / BCR::ABL1, Rare Fusion Monitoring, Quantitative, Varies.
If the patient has a negative history for p210 but has positive history of p190 or a rare fusion form, this test will be cancelled, and one of the following appropriate monitoring tests will be added:
-BA190 / BCR::ABL1, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies
-BARQ / BCR::ABL1, Rare Fusion Monitoring, Quantitative, Varies
Shipping Instructions
Specimen must arrive within 3 days (72 hours) of collection. Collect and package specimen as close to shipping time as possible.
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 whole 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
Whole 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 messenger RNA (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 |
Interpretation
An interpretive report will be provided. When BCR::ABL1 mRNA is present, quantitative results are reported on the international scale (IS), established from data originally reported in the IRIS (International Randomized Study of Interferon versus STI571) trial involving newly diagnosed chronic myeloid leukemia patients. Using the IS, a result of less than 0.1% BCR::ABL1 (p210):ABL1 is equivalent to a major molecular remission. This value is also designated on a log scale (Molecular Response, MR) as MR3. For further discussion of the international scale, see Clinical References.
Clinical Reference
1. Hughes TP, Kaeda J, Branford S, et al. Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med. 2003;349(15):1423-1432
2. Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122(6):872-884
3. Press RD, Kamel-Reid S, Ang D. BCR-ABL1 RT-qPCR for monitoring the molecular response to tyrosine kinase inhibitors in chronic myeloid leukemia. J Mol Diagn. 2013;15(5):565-576
4. Cross NC, White HE, Muller MC, Saglio G, Hochhaus A. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia. 2012;26(10):2172-2175
5. Shah NP, Bhatia R, Altman JK, et al. Chronic Myeloid Leukemia, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024;22(1):43-69. doi:10.6004/jnccn.2024.0007
Report Available
3 to 6 daysMethod Name
Quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Forms
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.