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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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Diagnostic workup of patients with high probability of BCR::ABL1-positive hematopoietic neoplasms, predominantly chronic myeloid/myelogenous leukemia and acute lymphoblastic leukemia

Method Name

Reverse Transcription Polymerase Chain Reaction (RT-PCR) Multiplex PCR


Ordering Guidance


Additional testing options are available. For ordering guidance see BCR/ABL1 Ordering Guide for Blood and Bone Marrow.



Shipping Instructions


1. Specimen must arrive within 72 hours of collection.

2. Collect and package specimen as close to shipping time as possible.



Necessary Information


Pertinent clinical history including if the patient has a diagnosis of chronic myeloid/myelogenous leukemia or other BCR/ABL1 positive neoplasm is required.



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 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 Type

Varies

Specimen Minimum Volume

Blood: 8 mL; Bone marrow: 2 mL

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

Reject Due To

Gross hemolysis Reject
Moderately to severely clotted Reject

Reference Values

An interpretive report will be provided.

Interpretation

An interpretive report will be provided.

 

When positive, the test identifies which specific messenger RNA fusion variant is present to guide selection of an appropriate monitoring assay. If common p210 or p190 fusion variant detected, quantitative reflex will be performed.

-Common fusion variants detected: e13-a2 or e14-a2 (p210), e1-a2 (p190), and e6-a2 (p205*)

-Rare fusion variants detected: e13-a3 (p210), e14-a3 (p210), e1-a3 (p190), e19-a2 (p230)

-Potential rare fusions detected: e12-a3, e19-a3

*This is formerly observed as the e6-a2 (p185) fusion form

Day(s) Performed

Monday through Saturday

Report Available

7 to 10 days

Test Classification

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

81206

81207

81208

81479 (if appropriate for government payers)

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

Forms

1. Hematopathology Patient Information (T676)

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

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 messenger RNA. 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 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.

 

For more information see:

-Myeloproliferative Neoplasm: A Diagnostic Approach to Bone Marrow Evaluation

-Myeloproliferative Neoplasm: A Diagnostic Approach to Peripheral Blood Evaluation

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
B190R BCR/ABL1, p190, Quant, Reflex Yes, (order BA190) (Bill Only) No
B210R BCR/ABL1, p210, Quant, Reflex Yes, (order BCRAB) (Bill Only) No