Alberta Precision Laboratories

--- Query Results ---

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:

PML::RARA t(15;17) Translocation (Synonym: APL Transcript Analysis, t(15;17) PML::RARA, t(15;17) PML::RARA Quantitation)

Clinical Indications:

Qualitative testing is performed for the investigation of acute leukemias.
Quantitative testing is performed for treatment monitoring in acute leukemias.

Test Includes:

Gene: PML::RARA

Ordering Alert:

Physicians specifically requesting quantitative testing should defer to Molecular Pathology North Zone specimen and ordering requirements as quantitative testing is only performed at the University of Alberta site.

Collection Alert:

In Calgary zone, test cannot be collected by Mobile Collection Service.
All zones, unopened dedicated tubes are required for Molecular testing.

LABID (Connect Care):

LAB4558

Specimen Type:

Bone marrow, Peripheral blood

Specimen Source:

Indicate a specimen source.

Primary Container:

See Specimen Collection Requirements

Minimum Collection Volume:

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 1.0 mL of bone marrow and
Collect one PAXgene^® Bone Marrow RNA tube containing a maximum of 2.0 mL of bone marrow.
Ensure to follow the specific specimen collection requirements: Place 1.0 to 2.0 mL of bone marrow into the EDTA tube and not more than 2.0 mL of bone marrow into the PAXgene^® tube. Order of draw is not important.

Bone Marrow

Collect one EDTA (lavender top) tube containing a minimum of 1.0 mL bone marrow.
Read transportation requirements before collection.

Peripheral Blood

Collect one EDTA tube containing a minimum of 1.0 mL of blood and
Collect one PAXgene^® Blood RNA tube containing a minimum of 2.5 mL of blood.
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 tubes each containing a minimum of 4.0 mL of blood.
Do not collect on Friday, Saturday or Sunday.
Do not collect on the day preceding a statutory holiday.
Read transportation requirements before collection.

Test Resources:

Submit request using the applicable requisition or Connect Care online order entry:

Molecular Pathology North		Molecular Pathology South
	Molecular Pathology Requisition
			Calgary Bone Marrow Collections: Bone Marrow Pathology Requisition
			Calgary Peripheral Blood Collections: Molecular Hematology Requisition

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

Stability and Storage:

Refrigerated until ready for transport.

Processing:

Molecular Pathology North

Molecular Pathology South

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

For Peripheral Blood:

Send one EDTA tube and the PAXgene^® Blood RNA tube to Molecular Pathology.
Send EDTA tube for a CBC to be processed as per local handling practice (only if no CBC has been done in the last month). This is a reflex action in Epic Beaker.

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

Transportation:

Molecular Pathology North	Molecular Pathology South
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.	Transport specimens as soon as possible on ice or cold pack. Specimen must be received in Molecular Pathology South by 15:00 the day following collection. Specimen will not be accepted if it arrives on Saturday, Sunday or on a statutory holiday Test may be cancelled if specimen is received by Molecular Pathology South more than 48 hours after collection.

Method and Interpretation of Results:

Molecular Pathology North
Qualitative test method: Real-time PCR

RNA extraction was performed on the QIAsymphony. cDNA synthesis and amplification of t(15;17) gene transcripts was performed in two steps by RT qPCR with ABL1 as the reference gene. Fluorescence detection was by the QuantStudio real time PCR platform (Life Technologies). Appropriate positive and negative controls were used. The limit of detection (LOD) of this assay is a 5.0 log reduction from the mean of pooled positive diagnostic samples.

Quantitative test method: Real-time PCR

RNA extraction was performed on the QIAsymphony. cDNA synthesis and quantitation of t(15;17) gene transcripts was performed in two steps by RT-qPCR with ABL1 as the reference gene. Fluorescence detection was by the QuantStudio real time PCR platform (Life Technologies). Appropriate positive and negative controls were 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 PML/RARA transcript from the initial diagnostic sample. The NCN is the ratio of PML/RARA transcripts to ABL1 transcripts. The limit of detection (LOD) of this assay is a 5.0-log reduction from the mean of pooled positive diagnostic samples, which corresponds to 0.001% residual disease.

Routine Turn Around Time:

Molecular Pathology North	Molecular Pathology South
Qualitative Routine (3 days) Stat RUSH (1 day)	Qualitative Performed at Molecular Pathology North, refer to Molecular Pathology North for expected TAT.
Quantitative 1 week

Testing Schedule:

Molecular Pathology North	Molecular Pathology South
Qualitative Upon request	Qualitative Performed at Molecular Pathology North, refer to Molecular Pathology North for expected TAT.
Quantitative 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	Molecular Pathology South
780-407-6648	587-231-3199

Last Updated On:

Friday, December 13, 2024

Date of Last Review:

Oct 21 2024 12:00AM

Registered Trademark Comments:

PAXgene^® is a trademark of PreAnalytiX GmbH.