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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


Shipping Instructions


Specimen must arrive within 72 hours of draw. Draw 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: ACD

Specimen Volume: 10 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send specimen in original tube.

3. Label specimen as blood.

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: ACD

Specimen Volume: 3 mL

Collection Instructions:

1. Invert several times to mix bone marrow.

2. Send specimen in original tube.

3. Label specimen as bone marrow.


Forms

1. Hematopathology Patient Information (T676) in Special Instructions

2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request Form (T726) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/hematopathology-request-form.pdf)

Useful For

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

 

When positive, the test identifies which specific mRNA fusion variant is present to guide selection of an appropriate monitoring assay.

Testing Algorithm

When a positive 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 p210 or p190 result will specifically trigger either quantitative p210 (B210R) or p190 (B190R) 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 BCR/ABL1 detected, then no reflex testing will be pursued and the initial results will be reported.

Method Name

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

Reporting Name

BCR/ABL1 Reflex, Qual/Quant

Specimen Type

Varies

Specimen Minimum Volume

Blood: 4 mL
Bone Marrow: 1 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Refrigerated (preferred) 72 hours
  Ambient  72 hours

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

NA

Icterus

NA

Other

Moderately to severely clotted

Reference Values

An interpretive report will be provided.

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

7 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test uses a standard method. Its performance characteristics were 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-BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative

81206-BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative

81207-BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative

81206-BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, quantitative (If appropriate)

81207-BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, quantitative (If appropriate)

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 In Process
48388 Final Diagnosis In Process

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