--- Query Results ---

Program:Genetics and Genomics
Test Name:t(9;22) BCR/ABL1
Performing Site: University of Alberta Hospital
Performing Dept:Molecular Pathology
Availability:Initial cases are set-up every other day (not including weekends or statutory holidays).
Monitor cases are set-up biweekly, on Wednesday.
TAT:See Comments section for TAT details.
Preferred Tube/Container:See Specimen Requirements
Specimen Requirements:For Blood Samples:Unopened dedicated tubes are required for Molecular Pathology testing.
1. Any peripheral blood requests will require a CBC and differential to be ordered and processed as per local handling practices.
2. Collect 2 x 4 mL EDTA (lavender) tubes. One tube for CBC/differential and one tube for Molecular Pathology.
3. Collect 1 x PAXgene Blood RNA for Molecular Pathology.
4. Ensure to follow the specific specimen collection requirements.
Using a butterfly needle and holding the tube below the arm to prevent backflow of contents into the patient, first collect 2 x 4 mL EDTA tubes, then 2.5 mL blood into the PAXgene Blood RNA tube.
Collection must be in the correct order of draw to ensure accurate white count determination.

For Bone Marrow Samples:Unopened dedicated tubes are required for Molecular Pathology testing
1. Collect 1 x 4mL EDTA (lavender) tube.
2. Collect 1 x PAXgene Bone Marrow RNA tube.
3. Ensure to follow the specific specimen collection requirements.
Place 2 mL of bone marrow into the EDTA tube and not more than 2 mL of bone marrow into the PAXgene Bone Marrow RNA tube. Order of draw is not important.
Specimen Processing:Immediately following collection, place all tubes ON ICE.
Do not spin.
Keep samples refrigerated until ready for transport.
Specimen Handling:Transport samples to Molecular Pathology as soon as possible, on ice or cold pack.
Molecular Pathology must receive the sample within 24 hours of collection.
If transport to Molecular Pathology is anticipated to be greater than 24 hours, contact Molecular Pathology at 780-407-6648.
Additional Information:PAXgene collection tubes are available upon request. Submit an order form using one of the links provided: Client Supply Order Edmonton Zone or Client Supply Order Provincial Form
Requisition/Form:All requests MUST be submitted on a Molecular Pathology Requisition.
Please provide any pertinent clinical history on the requisition.
Indications:For the investigation of myeloproliferative neoplasms and/or acute leukemias.
Method:Detection assay - PCR followed by capillary electrophoresis.
Quantitation assay - Real-time PCR
Method Details:BCR/ABL1 Detection Assay
RNA extracted from the sample is reversed transcribed and the resultant cDNA is subjected to PCR. This qualitative, lab-developed assay is designed as a multiplex PCR. The amplified DNA is then run on the 3500xL genetic analyzer for detection and analysis.

The assay is capable of detecting nine different BCR/ABL1 fusion transcripts: b2a2, b3a2, e1a2 (most commonly found in CML and ALL) as well as b2a3, b3a3, e6a2, e8a2, e1a3 and e19a2.

BCR amplification is also measured in every sample to test whether a sample has sufficient quantity and quality of RNA.

The limit of detection (analytical sensitivity) for b2a2, b3a2 and e1a2 fusions was determined to be 3.5 log reduction.

p210 BCR/ABL1 Quantitation AssayAfter RNA isolation and cDNA synthesis, real-time quantitation of BCR-ABL1 gene transcripts was performed using the BCR-ABL Mbcr IS-MMR Kit purchased from QIAGEN (Hilden, Germany). Appropriate positive and negative controls were used.

Results are reported on the International Scale (IS) which is calibrated against the first NIBSC WHO IS standard (ref. 09/138).

The analytical sensitivity of the UAH Molecular Pathology assay is 0.0032% (4.5 Log Reduction).
Comments:TAT Details
Qualitative assay:
1) Acute myeloid and lymphocytic leukemias (AML and ALL):
    3 business days (5 calendar days)
2) Other samples:
    8 business days (10 calendar days)
Quantitative assay:
1 month for monitor cases
Last Updated On:Thursday, October 3, 2019
Date of Last Review:Jan 2 2018 12:00AM