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Test ID LBOR0143 BCR/ABL1, Qualitative, Diagnostic Assay, Varies

Useful For

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

 

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

 

Monitoring purposes when a quantitative monitoring assay is not available for a rare fusion variant

Specimen Type

Varies


Advisory Information


This test is only qualitative and should not be used for routine monitoring (ie, quantitative mRNA level).

 

Monitoring of most patients with chronic myeloid leukemia (CML) should be performed using BCRAB / BCR/ABL, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myelogenous Leukemia (CML), Varies.

 

Monitoring of patients known to carry a p190 fusion should be performed using BA190 / BCR/ABL, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies.



Shipping Instructions


Refrigerate specimens must arrive within 5 days (120 hours) of collection, and ambient specimens must arrive with 3 days (72 hours) of collection. Collect and package specimens 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 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: 4 mL

Collection Instructions:

1. Invert several times to mix bone marrow.

2. Send specimen in original tube.

3. Label specimen as bone marrow.


Specimen Minimum Volume

Peripheral blood: 4 mL
Bone marrow: 2 mL

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

NA

Icterus

NA

Other

Moderately to severely clotted

Specimen Stability Information

Specimen Type Temperature Time
Varies Refrigerated (preferred) 5 days
  Ambient  72 hours

Day(s) and Time(s) Performed

Monday through Saturday; a.m.

Analytic Time

5 days

Method Name

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

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

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

81208-BCR/ABL1 (t[9;22]) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative

Reporting Name

BCR/ABL1, RNA-Qual, Diagnostic

Testing Algorithm

The following algorithms are available in Special Instructions:

-Myeloproliferative Neoplasm: A Diagnostic Approach to Bone Marrow Evaluation

-Myeloproliferative Neoplasm: A Diagnostic Approach to Peripheral Blood Evaluation

 

See BCR/ABL1 Ordering Guide for Blood and Bone Marrow in Special Instructions.

Reference Values

A qualitative result is provided that indicates the presence or absence of BCR/ABL1 mRNA. When positive, the fusion variant is also reported.

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.

Secondary ID

89006

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.

Sanford Laboratories - Fargo Additional Information:

Sanford Laboratory Interface Build Information

Result Code Result Code Description
20415 Diagnostic BCR/ABL1 Result
17482 Specimen Type
17483 Interpretation