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Test Code LAB0220894 BCR::ABL1, Qualitative, Diagnostic Assay, Varies

Additional Codes

Mayo Test ID
BADX

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Initial diagnosis of BCR::ABL1-positive hematologic neoplasms (eg, chronic myeloid leukemia and acute lymphoblastic leukemia)

 

 Detection and identification of BCR::ABL1 fusion forms, including the common p210 (e13/e14a2) and p190 (e1a2) forms, as well as other rare fusion forms

 

This test is not useful for therapeutic monitoring of patients with a known BCR::ABL1 fusion form.

Method Name

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

Reporting Name

BCR/ABL1, RNA-Qual, Diagnostic

Specimen Type

Varies


Ordering Guidance


This test is qualitative only and should not be used for routine therapeutic measurable residual disease monitoring.

 

To monitor patients carrying BCR::ABL1 fusion forms coding for p190 (e1a2), order BA190 / BCR::ABL1, p190 mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies.

 

To monitor patients carrying BCR::ABL1 fusion forms coding for p210 (e13/e14a2) protein, order BCRAB / BCR::ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies.

 

To monitor patients carrying rare BCR::ABL1 fusion forms coding for e19a2, e13/e14a3, e1a3, e6a2, e19a3, e8a2, e12a2, e6a3, e8a3, and e12a3, order BARQ / BCR::ABL1, Rare Fusion Monitoring, Quantitative, Varies.



Shipping Instructions


Refrigerate specimens must arrive within 5 days of collection, and ambient specimens must arrive within 72 hours of collection. Collect and package specimens as close to shipping time as possible.



Necessary Information


Pertinent clinical history including the patient diagnosis of chronic 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 whole 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 Minimum Volume

Whole blood: 8 mL; Bone marrow: 2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 5 days 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

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

Interpretation

An interpretive report will be provided.

 

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

Monitoring is available for common p210 or p190 fusion variant detected.

-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

5 to 10 days

Specimen Retention Time

Whole blood/Bone marrow: 2 weeks; Extracted RNA: 3 months

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BADX BCR/ABL1, RNA-Qual, Diagnostic 55135-8

 

Result ID Test Result Name Result LOINC Value
39466 Diagnostic BCR/ABL1 Result No LOINC Needed
MP001 Specimen Type 31208-2
19783 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.