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Test Code Epic LAB2842 BCR/ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies

Additional Codes

SQ code BCRAB

Mayo code BCRAB

Reporting Name

BCR/ABL1, p210, Quant, Monitor

Specimen Type

Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Monitoring response to therapy in patients with chronic myeloid leukemia who are known to have the e13/a2 or e14/a2 BCR/ABL1 fusion transcript forms

Testing Algorithm

For information see BCR/ABL1 Ordering Guide for Blood and Bone Marrow.


Shipping Instructions


Specimen must arrive within 72 hours of collection. Collect and package specimen as close to shipping time as possible. Specimens greater than 3 days old at the time of receipt will be considered unacceptable.



Necessary Information


Pertinent clinical history including if the patient has a diagnosis of chronic myeloid leukemia or other BCR/ABL1-positive neoplasm information 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: 3 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

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

Reference Values

The presence or absence of BCR/ABL1 mRNA fusion form e13/e14-a2 producing the p210 fusion protein is identified. If positive, the quantitative level is reported as the normalized ratio of BCR/ABL1 (p210) to endogenous ABL1 mRNA with conversion to a percentage referenced to the international scale (IS), on which 0.1% BCR/ABL1:ABL1 (also represented on a log scale as Molecular Response 3, or MR3) is designated as a major molecular response (MMR) threshold.

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BCRAB BCR/ABL1, p210, Quant, Monitor 55135-8

 

Result ID Test Result Name Result LOINC Value
48411 BCR/ABL1, p210 Result 55135-8
MP003 Specimen Type 31208-2
19598 Final Diagnosis: 34574-4

Reject Due To

Gross hemolysis Reject
Moderately to severely clotted Reject

Method Name

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

Method Description

The assay is performed using an automated platform, GeneXpert (Cepheid). Four mL of whole blood is processed, added to an individual sample cartridge and loaded onto the GeneXpert machine. All subsequent reactions are performed within the cartridge and the results are processed and calculated by the instrument. Within the cartridge, RNA is extracted and converted to complementary DNA (cDNA).

 

Quantitative, reverse transcription polymerase chain reaction (PCR) is performed with a nested PCR reaction containing primers designed to amplify cDNA from the e13/a2 and e14/a2 BCR/ABL1 fusion products. A fragment of ABL1 cDNA is also amplified as a control for RNA degradation and for normalization of BCR/ABL1 results. The ratio of BCR/ABL1 (p210) to ABL1 is calculated from the difference in the crossing thresholds of BCR/ABL1 (p210) and ABL1 products in relation to a lot-specific standard curve, referenced to the international scale (IS). Lot-to-lot variation in the cartridges is corrected using a calibration calculation to reference standard curve data to the IS provided by the manufacturer.(Unpublished Mayo method)

Report Available

3 to 6 days

Secondary ID

89007

Forms

1. Hematopathology Patient Information (T676)

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