Test Catalog

Test Id : BA190

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

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring response to therapy in patients with known e1/a2 BCR/ABL1 (p190) fusion forms

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

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, Monitor

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

Philadelphia chromosome, Ph bone marrow/blood

Acute lymphoblastic leukemia (ALL)

Acute myeloid leukemia (AML)

B lymphoblastic leukemia (B-ALL)

BCR ABL

BCR/ABL

BCR-ABL1

T lymphoblastic leukemia (T-ALL)

t(9;22)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This test should not be used to screen for BCR/ABL1 fusions at the time of diagnosis; order either BADX / BCR/ABL1, Qualitative, Diagnostic Assay, Varies; or BCRFX / BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies should be ordered for that purpose.

 

To monitor patients carrying BCR/ABL1 fusion forms coding for the p210 protein, which includes most patients with chronic myeloid leukemia (CML); order BCRAB / BCR/ABL, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies.

Shipping Instructions

Refrigerate specimens must arrive within 5 days (120 hours) of collection, and ambient specimens must arrive within 3 days (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 leukemia or other BCR/ABL1-positive neoplasm

2. Date of collection

3. Specimen source (blood or bone marrow)

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MP002 Specimen Type

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Preferred:

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

1. Hematopathology Patient Information (T676)

2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Blood: 8 mL

Bone marrow: 2 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) 5 days 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

Monitoring response to therapy in patients with known e1/a2 BCR/ABL1 (p190) fusion forms

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Messenger RNA (mRNA) transcribed from BCR/ABL1 (fusion of the breakpoint cluster region gene [BCR] at chromosome 22q11 to the Abelson gene [ABL1] at chromosome 9q34) is detected in all patients with chronic myeloid leukemia (CML) and a subset of patients with both acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). Although breakpoints in the BCR and ABL1 genes may occur in a variety of locations, splicing of the primary RNA transcripts result in only 8 fusion site variants (e1/a2, e6/a2, e13/a2, e14/a2, e19/a2, and e1/a3, e13/a3, e14/a3), which incorporate the entire sequence of the exons on both sides of the fusion site. The e1/a2 and e1/a3 fusion forms produce a 190-kDa protein designated p190. This BCR/ABL1 protein form is found in approximately 75% of patients with childhood ALL and approximately 50% of patients with adult ALL, with the majority arising from e1/a2 mRNA. The p190 is also the predominant fusion form in a small subset of patients with CML, although the vast majority of CML cases contain the p210 protein, typically from e13/a2 or e14/a2 mRNA fusions. Other fusion forms are very rare.

 

Quantitative reverse-transcription polymerase chain reaction (qRT-PCR) is the most sensitive method for monitoring BCR/ABL1 levels during treatment. This test detects mRNA coding for the most common p190 fusion form (e1/a2).

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.

The presence or absence of the BCR/ABL1 messenger RNA fusion form producing the p190 fusion protein is reported. If positive, the level is reported as the ratio of BCR/ABL1 (p190) transcript to ABL1 transcript in the form of a percentage.

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

This test detects only the e1/a2 BCR/ABL1 (p190) fusion form. Other fusion forms are not detected by this assay, including those containing the BCR e13 and e14 exons, which code for the p210 protein commonly found in chronic myeloid leukemia (CML), and the rare e1/a3 (p190) fusion form.

 

The precision of this assay at very low BCR/ABL1 levels is less reliable, such that inter-run variation can be more variable. If the results are being used to make major therapeutic decisions, significant changes during monitoring should be verified with a subsequent specimen.

 

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 fluorescence in situ hybridization (FISH) technology. FISH measures DNA alleles and this PCR-based assay measures messenger RNA (mRNA) transcripts. Because a single DNA allele can produce many mRNA transcripts, the values are not directly comparable.

 

Blood is the specimen of choice for monitoring. While most patients show similar BCR/ABL1 levels in blood and bone marrow drawn at the same time, some patients have a consistent difference in the levels in blood and bone marrow such that altering specimen types during monitoring can lead to confusion.

 

Assay precision does not appear to be significantly affected by specimen transport or moderate delays in processing. However, in specimen with very low levels of BCR/ABL1, these conditions may cause sufficient RNA degradation to produce false-negative results. Thus, specimens should be shipped as quickly as possible. Ambient specimens over 3 days old and refrigerate specimens over 5 days old at the time of receipt are unacceptable.

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;349:1423-1432

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;98:1701-1707

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;97:1560-1565

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 March 16, 2022. Available at https://ommbid.mhmedical.com/content.aspx?sectionid=225078035&bookid=2709

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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/ABL quantitative levels are determined using Taqman-type probe technology. The data is analyzed for relative quantification with calibrator normalization and efficiency correction. 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 a  percentage.(Unpublished Mayo method)

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

Supplemental

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 Saturday

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.

4 to 8 days

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

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. This test 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

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
BA190 BCR/ABL1, p190, Quant, Monitor In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
MP002 Specimen Type 31208-2
19765 Interpretation 69047-9
39470 BCR/ABL1 p190 Result No LOINC Needed

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 | 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

Test Update Resources

Change Type Effective Date
Test Changes - Specimen Information 2022-04-27
Test Changes - Specimen Information 2022-04-27