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Test Code Epic LAB5524 BCR/ABL1, Qualitative, Diagnostic Assay, Varies

Additional Codes

SUNQUEST: BADXM

MAYO: BADX

Reporting Name

BCR/ABL1, RNA-Qual, Diagnostic

Useful For

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


Ordering Guidance


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

 

Monitoring of most patients with chronic myeloid leukemia should be performed using BCRAB / BCR/ABL1, 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/ABL1, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies.

 

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



Shipping Instructions


1. Refrigerate specimens must arrive within 5 days of collection, and ambient specimens must arrive with 3 days of collection.

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



Necessary Information


Pertinent clinical history including if the patient has a 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 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

Peripheral 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

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.

Day(s) Performed

Monday through Saturday

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
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

Method Description

Total RNA is extracted from the patient's blood or bone marrow at the time of diagnosis and messenger RNA (mRNA) is reverse transcribed into complementary DNA (cDNA). The cDNA is then subjected to polymerase chain reaction (PCR) using 4 separate multiplex reactions. A qualitative result, which will include the relative ratio of target translocation mRNA to control GUSB gene mRNA, will be provided. Although this method employs a quantitative PCR platform, the results can be used to evaluate the relative expression levels of the translocation mRNA relative to control mRNA, thus, providing an improved measure of RNA quality in the assay. Reporting of results will be qualitative; either BCR::ABL1 mRNA positive/detected (with transcript type) or negative/not detected.(Unpublished Mayo method)

Report Available

5 to 10 days

Reject Due To

Gross hemolysis Reject
Moderately to severely clotted Reject

Method Name

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

Secondary ID

89006

Forms

1. Hematopathology Patient Information (T676)

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