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BCR/ABL1 Qualitative Diagnostic Assay with Reflex to BCR/ABL1 p190 Quantitative Assay or BCR/ABL1 p210 Quantitative Assay, Varies

Additional Codes

Primary ID Epic Code Mayo Test ID
BCRABX LAB3060 BCRFX

 


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.

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.

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 (T726) with the specimen.

Useful For

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

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 (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 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

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 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
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

Specimen Retention Time

RNA 3 months

Performing Laboratory

Mayo Clinic 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

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

NY State Approved

Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
B190R BCR/ABL1, p190, Quant, Reflex No, (Bill Only); For Separate Testing: (Order BA190) No
B210R BCR/ABL1, p210, Quant, Reflex No, (Bill Only); For Separate Testing: (Order BCRAB) No