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HelpTest Code BCRFX BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies
Reporting Name
BCR/ABL1 Reflex, Qual/QuantUseful For
Diagnostic workup of patients with high probability of BCR-ABL1-positive hematopoietic neoplasms, predominantly chronic myeloid/myelogenous leukemia and acute lymphoblastic leukemia
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
VariesAdvisory Information
For information on which test to order for various scenarios, see BCR/ABL1 Ordering Guide for Blood and Bone Marrow in Special Instructions.
Shipping Instructions
Specimen must arrive within 72 hours of collection. Collect and package specimen as close to shipping time as possible.
Necessary Information
The following information is required:
1. Pertinent clinical history including if the patient has a diagnosis of chronic myeloid/myelogenous leukemia or other BCR/ABL1 positive neoplasm
2. Date of collection
3. Specimen source (blood or bone marrow)
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 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 specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Specimen Minimum Volume
Blood: 4 mL
Bone marrow: 1 mL
Testing Algorithm
When a positive common p210 or p190 BCR/ABL1 result is identified by the qualitative assay, a reflex test will then be performed at an additional charge to determine the quantitative transcript level of BCR/ABL1 mRNA. A positive common p210 or p190 result will specifically trigger either quantitative p210 or p190 testing to provide a normalized percentage of transcript level. For the p210 target, the value is additionally defined using the International Scale (IS) convention. The results are released in an integrated report and provide a baseline quantitative transcript to monitor treatment response. If the initial qualitative testing is negative, or an alternate rare form of BCR/ABL1 is detected, then no reflex testing will be pursued and the initial results will be reported.
The following documents are available in Special Instructions:
-Myeloproliferative Neoplasm: A Diagnostic Approach to Bone Marrow Evaluation
-Myeloproliferative Neoplasm: A Diagnostic Approach to Peripheral Blood Evaluation
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
An interpretive report will be provided.
Day(s) and Time(s) Performed
Monday through Friday
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.CPT Code Information
81208
81206
81207
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| BCRFX | BCR/ABL1 Reflex, Qual/Quant | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| MP039 | Specimen Type | 31208-2 |
| 48389 | BCR/ABL1 Reflex Result | No LOINC Needed |
| 48388 | Interpretation | 69047-9 |
Clinical Reference
1. Burmeister T, Reinhardt R: A multiplex PCR for improved detection of typical and atypical BCR-ABL fusion transcripts. Leuk Res. 2008 Apr;32(4):579-585
2. Melo JV: The diversity of BCR-ABL fusion proteins and their relationship to leukemia phenotype. Blood. 1996 Oct 1;88(7):2375-2384
3. Melo JV: BCR-ABL gene variants. Baillieres Clin Haematol. 1997 Jun;10(2):203-222
4. Baccarini M, Deininger MW, Rosti G, et al: European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013;122:872-884
5. Cross NC, White HE, Muller MC, et al: Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia 2012;26:2172-2175
6. National Comprehensive Cancer Network Practice Guidelines in Oncology: Chronic Myeloid Leukemia 2015. Available at www.nccn.org
Method Description
Total RNA is extracted from the patient's blood or bone marrow at the time of diagnosis and mRNA is reverse transcribed into cDNA. The cDNA is then subjected to polymerase chain reaction (PCR) using 4 separate multiplex reactions. A qualitative result, which will include the relative ratio of target translocation mRNA to control GUSB gene mRNA, will be given by LightCycler 96 software. As this method employs a quantitative PCR platform, the results can be used to evaluate the relative expression levels of the translocation mRNA relative to control mRNA, thus providing an improved measure of RNA quality in the assay. Reporting of results will be qualitative; either BCR-ABL1 mRNA positive/detected (with transcript type) or negative/not detected.(Unpublished Mayo method)
Analytic Time
7 daysReject Due To
| Gross hemolysis | Reject |
| Moderately to severely clotted | Reject |
Method Name
Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Multiplex PCR
Forms
1. Hematopathology Patient Information (T676) in Special Instructions
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Secondary ID
65248Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| B190R | BCR/ABL1, p190, Quant, Reflex | Yes, (order BA190) | No |
| B210R | BCR/ABL1, p210, Quant, Reflex | Yes, (order BCRAB) | No |