Test Catalog

Test Id : B190R

Not Orderable

BCR/ABL1, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Reflex, Varies

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Overview

Test Catalog

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 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 e1-a2 (p190) 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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

BCR/ABL1, p190, Quant, Reflex

Aliases
Lists additional common names for a test, as an aid in searching

Philadelphia

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

Collection 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

Collection 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

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 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 e1-a2 (p190) 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 (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 e1-a2 (p190) type mRNA, the reflex test provides a corresponding p190 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 (PCR) 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.

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. Radich JP, Gooley T, Bryant E, et al. The significance of BCR-ABL molecular detection in chronic myeloid leukemia patients "late," 18 months or more after transplantation. Blood. 2001;98(6):1701-1707. doi:10.1182/blood.v98.6.1701

3. Olavarria E, Kanfer E, Szydlo R, et al. Early detection of BCR-ABL transcripts by quantitative reverse transcriptase-polymerase chain reaction predicts outcome after allogeneic stem cell transplant for chronic myeloid leukemia. Blood. 2001;97(6):1560-1565

4. Tefferi A. The classic myeloproliferative neoplasms: Chronic myelogenous leukemia, polycythemia vera, essential thrombocythemia, and primary myelofibrosis. In: Valle DL, Antonarakis S, Ballabio A, Beaudet AL, Mitchell GA, eds. The Online Metabolic and Molecular Bases of Inherited Disease. McGraw-Hill; 2019, Accessed December 27, 2023. Available at https://ommbid.mhmedical.com/content.aspx?sectionid=225078035&bookid=2709

Method Description
Describes how the test is performed and provides a method-specific reference

Total RNA is extracted and reverse transcribed to complementary DNA. Quantitative real time polymerase chain reaction is performed and p190/ABL1 relative quantitative levels are determined using TaqMan-type probe technology. The data is analyzed using the supplied software for relative quantification with calibrator normalization. The reference gene, ABL1, is used to control for RNA degradation in the sample and the calibrator is used to control for inter-run variations. A normalized ratio of BCR/ABL1 (p190) mRNA:ABL1 mRNA is obtained and reported in the form of percentage.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Whole blood, bone marrow: 2 weeks; Extracted RNA: 3 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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.

81207

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports