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Test Code LAB0210765 BCR::ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies

Additional Codes

Mayo Test ID
BCRAB

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Therapeutic monitoring of BCR::ABL1 p210 (e13/e14a2)-positive hematologic neoplasms (eg, chronic myeloid leukemia, acute lymphoblastic leukemia)

 

This test should not be used to screen for BCR::ABL1 fusion forms at the time of diagnosis or quantitative therapeutic monitoring of p190 or rare fusion forms.

Testing Algorithm

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

Method Name

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

Reporting Name

BCR/ABL1, p210, Quant, Monitor

Specimen Type

Varies


Ordering Guidance


This test is intended for therapeutic monitoring in patients with a known e13/e14a2 (p210) fusion form and should not be used to screen for BCR::ABL1 fusion forms at the time of diagnosis.

 

To screen for BCR::ABL1 fusion forms at diagnosis, order one of the following:

BADX / BCR::ABL1, Qualitative, Diagnostic Assay, Varies

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

 

To monitor patients carrying BCR::ABL1 fusion form coding for the p190 (e1A2), order BA190 / BCR::ABL1, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies.

 

To monitor patients carrying rare BCR::ABL1 fusion forms coding for e19a2, eE13/eE14a3, e1a3, e6a2, e19a3, e8a2, e12a2, e6a3, e8a3, or e12a3, order BARQ / BCR::ABL1, Rare Fusion Monitoring, Quantitative, Varies.



Shipping Instructions


Send specimen Monday through Friday only. Specimens must arrive within 72 hours of collection and by 10 a.m. Central time Saturday.

 

Specimens received after 10 a.m. Saturday or on Sunday may be canceled due to stability limitations.

 

Collect and package specimen as close to shipping time as possible.



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 whole 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

Whole 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
Moderately to severely clotted Reject

Reference Values

The presence or absence of BCR::ABL1 messenger RNA (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.

Interpretation

An interpretive report will be provided. When BCR::ABL1 mRNA is present, quantitative results are reported on the international scale (IS), established from data originally reported in the IRIS (International Randomized Study of Interferon versus STI571) trial involving newly diagnosed chronic myeloid leukemia patients. Using the IS, a result of less than 0.1% BCR::ABL1 (p210):ABL1 is equivalent to a major molecular remission. This value is also designated on a log scale (Molecular Response, MR) as MR3. For further discussion of the international scale, see Clinical References.

Day(s) Performed

Monday through Saturday

Report Available

3 to 6 days

Specimen Retention Time

2 weeks

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

Forms

1. Hematopathology Patient Information (T676)

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