Alberta Precision Laboratories

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Organization:

Alberta Precision Laboratories

Message Alert:

PLEASE NOTE: This Test Directory is in an interim state and due to changes pertaining to the DynaLIFE transition, performing site for routing has not been updated. Please refer to Laboratory Information System for appropriate routing.

Test Name/Synonym:

BCR::ABL1 Mutation Analysis (Synonym: BCR::ABL1 Tyrosine Kinase Inhibitor Resistance, ABL-Kinase Domain Mutation Analysis Ref)

Clinical Indications:

For evaluating patients with chronic myelogenous leukemia and Philadelphia chromosome positive B-cell acute lymphoblastic leukemia receiving tyrosine kinase inhibitor (TKI) therapy, who are apparently failing treatment.

Test Includes:

Gene: BCR::ABL1

LABID (Connect Care):

LAB4349

Specimen Type:

Bone marrow, Peripheral blood

Specimen Source:

Indicate specimen source.

Primary Container:

See Specimen Collection Requirements.

Specimen Collection Requirements:

Molecular Pathology North

Molecular Pathology South

Bone Marrow

Collect one EDTA (lavender top) tube containing a minimum of 1 mL of bone marrow (this tube is for the Molecular Pathology North lab) and
Collect one PAXgene^® Bone Marrow RNA tube containing a maximum of 2 mL of bone marrow. This tube is for the Molecular Pathology North lab.
Order of draw is not important.

Bone Marrow

Collect bone marrow minimum of 1mL in a non heparin syringe and transfer to Lavender top EDTA tube
Read transportation requirements before collection.

Peripheral Blood

Collect one EDTA (lavender top) tube containing a minimum of 1 mL of peripheral blood and
Collect one PAXgene^® Blood RNA tube containing a minimum of 2.5 mL of blood. This tube is for the Molecular Pathology North lab.
An additional EDTA tube will be required for CBC testing if no CBC has been done in the last month (reflex action in Epic Beaker).
Ensure to follow the specific specimen collection requirements: Using a butterfly needle and holding the tubes below the arm, first collect the EDTA tube(s), then the PAXgene^® Blood RNA tube.
Collection must be in the correct order of draw to ensure accurate white count determination.

Peripheral Blood

Collect two EDTA (lavender top) tubes containing a minimum of 3 mL of peripheral blood in each tube.
Collect Mondays and Tuesday morning preferred but not required.
Read transportation requirements before collection

Test Resources:

Submit requests using requisition or Connect Care online order entry:

Please ensure all required information, including patient's clinical history/indication, is provided on the requisition.

Edmonton and area: pdf-mclendon-labs-mol-test-req.pdf (uncmedicalcenter.org)
Calgary and area: Please call Dynacare at 800-565-5721 for requisition.

Stability and Storage:

Refrigerated

Processing:

Molecular Pathology North

Molecular Pathology South

Immediately following collection, place all tubes ON ICE or COLD PACK.
Do not centrifuge, aliquot or freeze.

For Bone Marrow:

Send all tubes to the Molecular Pathology lab.

For Peripheral Blood:

Send all tubes to the Molecular Pathology lab.
Send EDTA tube for a CBC to be processed as per local handling practice (only if no CBC has been done in the past month). This is a reflex action in Epic Beaker.

For both Peripheral blood and Bone Marrow:

Immediately following collection, place all tubes ON ICE or refrigerate.
Do not centrifuge, aliquot or freeze.

Transportation:

Molecular Pathology North

DSC External Sendout

Transport specimens as soon as possible, on ice or cold pack.
Molecular Pathology must receive the specimens within 24 hours of collection.
If transport is anticipated to be greater than 24 hours after collection, contact Molecular Pathology.
Extracted RNA will be sent to the referral laboratory (shipped frozen on dry ice). An acceptable volume is at least 25 uL of RNA.
Please provide a copy of the current BCR:ABL1 p190 and p210 results which are required before tesing will begin.
Label each sample with the first and last name, date of birth, date and time of collection.

Transport at room temperature to reach referral laboratory within 48 hours of collection
Specimen must be received in DSC External Sendout by 13:00 the day of collection.
Include completed Dynacare, Genetic and Specialty Molecular Diagnostics- Hematology requisition Test:BCR-ABL Drug Resistance (MUTB), Specimen type: Blood
Read transportation requirements before collection

Method:

Edmonton and area: Real-time PCR followed by DNA sequencing.
Calgary and area: N/A

Method and Interpretation of Results:

Edmonton and area: RT-PCR of the BCR::ABL1 fusion gene RNA was performed followed by DNA sequencing of the ABL kinase domain, including the P-loop, catalytic domain, and activation loop. This assay can detect a mutant comprising at least 20% of BCR::ABL1 transcripts. Nomenclature is based on reference sequence NM_005157. The reference value for this test is: Negative for resistance mutations.
Calgary and area: N/A

Routine Turn Around Time:

Edmonton and area: 14 days
Calgary and area: 17 days

Testing Schedule:

Edmonton and area: Weekly; no weekends or holiday
Calgary and area: N/A

Testing Area:

Edmonton and area: University of North Carolina Health Molecular Genetics Lab
Calgary and area: Dynacare Next

Performing Site:

Edmonton and area:
McLendon Clinical Laboratories
Outreach Services, 1st floor, East Wing
UNC Hospitals
Chapel Hill, North Carolina 27514
Phone: 984-974-1810 or 984-974-1680

Calgary and area: Dynacare Next/GDSD
3885 Boul Industriel
STE-Rose, PQ
H7L 4S3
Phone: (450) 901-3071

Additional Test Information:

PAXgene^® collection tubes are available upon request.
Submit an order as per online Client Order Form Submission process.
Details in following document: RR01-005 Ordering Supplies from Reagent Room

Contact Comments:

Molecular Pathology North: 780-407-6648
Molecular Pathology South: 587-231-3199

Last Updated On:

Tuesday, December 17, 2024

Registered Trademark Comments:

PAXgene^® is a trademark of PreAnalytiX GmbH