Test Id : B210R
BCR/ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Reflex, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnostic workup of patients with a high probability of BCR-ABL1-positive hematopoietic neoplasms, particularly chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia (B-lymphoblastic leukemia), to provide a pretreatment quantitative level of BCR-ABL1 mRNA transcript if the initial diagnostic reverse transcription polymerase chain reaction screen is positive
When positive, the reflex test provides a quantitative value for the corresponding e13-a2 or e14-a2 (p210) BCR-ABL1 mRNA fusion variant
Method Name
A short description of the method used to perform the test
Only orderable as a reflex. For more information see BCRFX /BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies.
Quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Philadelphia Chromosome Ph1 Bone Marrow/Blood
Philadelphia
BCR/ABL
Chronic Myelogenous Leukemia (CML)
CML (Chronic myeloid/Myelogenous Leukemia)
Specimen Type
Describes the specimen type validated for testing
Varies
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Only orderable as a reflex. For more information see BCRFX /BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies.
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: 4 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
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
8 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Moderately to severely clotted | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | 72 hours | PURPLE OR PINK TOP/EDTA |
| Ambient | 72 hours | PURPLE OR PINK TOP/EDTA |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnostic workup of patients with a high probability of BCR-ABL1-positive hematopoietic neoplasms, particularly chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia (B-lymphoblastic leukemia), to provide a pretreatment quantitative level of BCR-ABL1 mRNA transcript if the initial diagnostic reverse transcription polymerase chain reaction screen is positive
When positive, the reflex test provides a quantitative value for the corresponding e13-a2 or e14-a2 (p210) BCR-ABL1 mRNA fusion variant
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The t(9;22)/BCR-ABL1 abnormality is associated with chronic myeloid leukemia (CML) and "Philadelphia positive" acute lymphoblastic leukemia of B-cell lineage (Ph ALL). Very rarely, this abnormality has also been identified in cases of acute myeloid leukemia and T-lymphoblastic leukemia/lymphoma. The fusion gene on the derivative chromosome 22q11 produces a chimeric BCR-ABL1 messenger RNA (mRNA) transcript and corresponding translated oncoprotein. Despite substantial breakpoint heterogeneity at the DNA level, a consistent set of BCR-ABL1 mRNA transcripts are produced that can be readily and sensitively detected by reverse transcription polymerase chain reaction (RT-PCR) technique. In CML, breakpoints in BCR nearly always result in either exons 13 or 14 (e13, e14) joined to exon 2 of ABL1 (a2). The corresponding e13-a2 or e14-a2 BCR-ABL1 mRNAs produce a 210 kDa protein (p210). Rare cases of CML are characterized by an e19-a2 type mRNA with a corresponding p230 protein. In Ph ALL, the majority of cases harbor an e1-a2 BCR-ABL1 mRNA transcript, producing a p190 protein, although some ALL patients may alternatively present with the e13/e14-a2 or p210 type fusion.
This assay provides information at the time of diagnosis regarding the presence (and specific mRNA type) or absence of the BCR-ABL1 mRNA. If positive, the reflex test will follow to provide an initial quantitative level of the specific BCR-ABL1 transcript. For example, when positive for the e13/e14-a2 (p210) type mRNA, the reflex test provides a corresponding p210 quantitative value. Results from this test are also useful to determine the correct quantitative assay for subsequent monitoring of transcript levels (ie, p190 or p210) during tyrosine kinase inhibitor therapy.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Only orderable as a reflex. For more information see BCRFX / BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies.
Interpretation
Provides information to assist in interpretation of the test results
An interpretive report will be provided.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
In general, the results of this assay cannot be directly compared with results generated from other polymerase chain reaction assays, including identical assays performed in other laboratories. Monitoring should be performed using the same method and laboratory for each subsequent specimen.
If a rare alternative BCR-ABL1 mRNA transcript (eg, e19-a2/p230, or other) is identified by diagnostic reverse-transcription polymerase chain reaction (RT-PCR), a reflex test cannot be performed as quantitative testing for these rare transcripts is not currently available.
For diagnostic reflex testing to quantitative RT-PCR for the p210 type mRNA, only normalized BCR-ABL1/ABL1 values greater than or equal to 1% (IS) will be numerically reported. The reflex test is intended for use at diagnosis, when relatively high levels of BCR-ABL1 p210 mRNA are present, and to establish the initial baseline prior to tyrosine kinase inhibitor therapy. Levels below 1% will be most likely consistent with posttherapy samples and will, therefore, only be reported qualitatively for this assay (eg, "a low level of BCR-ABL1 p210 mRNA is present"). In this case, a recommendation will be provided for submission of a new EDTA anticoagulated peripheral blood or bone marrow specimen to determine and report a more accurate quantitative value using BCRAB / BCR/ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies. Given the nature of the reflex test, normalized BCR-ABL1/ABL1 mRNA levels below 1% are not considered reliable and accurate quantification will require submission of a new blood or marrow specimen for the specific BCRAB test.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
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. National Comprehensive Cancer Network Practice Guidelines in Oncology: Chronic Myeloid Leukemia 2015. Accessed December 27, 2023. Available at www.nccn.org
Method Description
Describes how the test is performed and provides a method-specific reference
The assay is performed using an automated platform, GeneXpert (Cepheid). All subsequent reactions are performed within the cartridge and the results are processed and calculated by the instrument. Quantitative, reverse transcription polymerase chain reaction (PCR) is performed with a nested PCR reaction Lot-to-lot variation in the cartridges is corrected using a calibration calculation to reference standard curve data to the IS provided by the manufacturer.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
81206