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Test Code LAB1231764 BCR::ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies

Important Note

Mayo code is BCRAB

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.


Reject Due To

Gross hemolysis Reject
Moderately to severely clotted Reject

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

Specimen Minimum Volume

Whole blood: 4 mL; Bone marrow: 1 mL

Day(s) Performed

Monday through Saturday

Specimen Retention Time

2 weeks

Report Available

3 to 6 days

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.

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.

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

Method Description

The assay is performed using an automated platform, GeneXpert (Cepheid). Four milliliters 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)

Forms

1. Hematopathology Patient Information (T676)

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