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:

t(8;21) RUNX1::RUNX1T1 Diagnostic (Synonyms: Qualitative RUNX1::RUNX1T1, Qualitative t(8;21), AMLD)

Clinical Indications:

For the investigation of acute leukemias.

Test Includes:

Gene: RUNX1::RUNX1T1

Ordering Alert:

This page provides information for requirements for this test to be performed by Molecular Pathology North.

For information for requirements for this test to be performed by Cytogenetics: for submission in south sector refer to Cytogenetic Analysis, Cancer or for submission in north sector refer to Cytogenetic Analysis, Constitutional.

Collection Alert:

Unopened dedicated tubes are required for Molecular Pathology testing.

LABID (Connect Care):

LAB4209

Specimen Type:

Bone marrow, Peripheral blood

Specimen Source:

Indicate a specimen source.

Primary Container:

See Specimen Collection Requirements

Specimen Collection Requirements:

For Bone Marrow:

Collect one EDTA tube containing a minimum 1.0 mL of bone marrow and
Collect one PAXgene^® Bone Marrow RNA tube containing a maximum 2.0 mL of bone marrow.

For Peripheral Blood:

Collect two EDTA tubes each containing a minimum 1.0 mL of blood and
Collect one PAXgene® Blood RNA tube containing a minimum 2.5 mL of blood
Ensure to follow the specific specimen collection requirements: Using a butterfly needle and holding the tube below the arm to prevent backflow, first collect 2 EDTA tubes, then the PAXgene^® Blood RNA tube.
Collection must be in the correct order of draw to ensure accurate white count determination.

Test Resources:

Submit requests using requisition or Connect Care online order entry:

Molecular Pathology Requisition

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

Stability and Storage:

Refrigerated

Processing:

Immediately following collection, place all tubes ON ICE.

Do not centrifuge or aliquot.
Do not freeze.

For Peripheral Blood:

Send one EDTA tube for a CBC to be ordered and processed as per local handling practices.
Send one EDTA and the PAXgene® Blood RNA tube to Molecular Pathology.

Transportation:

Transport specimens as soon as possible, on ice or cold pack.

Molecular Pathology must receive the specimen within 24 hours of collection.

If transport is anticipated to be greater than 24 hours after collection, contact Molecular Pathology.

Method:

Real-time PCR

Method and Interpretation of Results:

cDNA synthesis and quantitation of t(8:21) gene transcripts is performed in a single well using the Express One-Step Superscript qRT PCR mastermix (Life Technologies) with ABL1 as the reference gene. Fluorescence detection is performed on the Quant Studio real time PCR platform (Life Technologies). Appropriate positive and negative controls are used.

The results are expressed as percentage residual disease and a calculated log reduction (LR). The residual disease is the percentage of NCN of the monitor sample to the NCN of the initial diagnostic sample. The LR is the log reduction in the normalized copy number (NCN) of RUNX1::RUNX1T1 transcript from the initial diagnostic sample. The NCN is the ratio of RUNX1::RUNX1T1 transcripts to ABL1 transcripts.

The limit of detection (LOD) of this assay is a 4.0-log reduction from the mean of pooled positive diagnostic samples, which corresponds to 0.01% residual disease.

Routine Turn Around Time:

3 days

Testing Schedule:

Weekly

Testing Area:

Molecular Pathology

Performing Site:

University of Alberta Hospital

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

Last Updated On:

Wednesday, February 14, 2024

Date of Last Review:

Feb 7 2024 12:00AM

Registered Trademark Comments:

PAXgene^® is a trademark of PreAnalytiX GmbH.