Test Code LAB1231764 BCR::ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Varies
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Reporting Name
BCR/ABL1, p210, Quant, MonitorSpecimen Type
VariesOrdering 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
Special Instructions
Day(s) Performed
Monday through Saturday
Specimen Retention Time
2 weeksReport Available
3 to 6 daysReference 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.