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Test 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/Quant

Useful 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

Varies


Advisory 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

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 days

Reject 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

65248

Reflex 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