BCR/ABL1 PCR-D, t(9;22)(q34;q11.2), Diagnostic sample

WSLH Department: Cytogenetics
WSLH Test Code: 887M31, 893M51 or 52
Availability: Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM
Turn-around Time: Approximately 2-4 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM)
Recommended Uses: Detection of BCR/ABL1 fusion transcripts associated with chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL) in newly diagnosed patients.
Additional Tests Performed:
Patient Preparations:
Specimen Requirements: **1.0-2.0 ml early aspirate bone marrow


**5-10 ml whole blood collected in EDTA vacuum type tube
Specimen Handling & Transport: Store and transport specimens at room temperature (may transport with coolant during hot weather, >85 degrees F). DO NOT FREEZE. The laboratory must receive specimens within 24 hours of collection.
Collection Kit/Container:
Collection Instructions: **Bone marrow: 1.0-2.0 ml bone marrow from the first or second aspirate. It is important that material submitted for cytogenetic analysis is from an early aspirate. Later aspirates are likely to be diluted with blood and the abnormal clone may not be detected. Transfer the marrow to a sterile, EDTA vacuum type tube for delivery to State Lab.

**Blood: Draw blood using aseptic techniques into a sterile EDTA vacuum type tube(s). Invert tube(s) to mix. If using larger tubes, draw full tube(s) of blood to avoid over-treatment with anti-coagulant.
Unacceptable Conditions: Sample must not be frozen or hemolyzed. Please note that sodium heparin is known to inhibit PCR. Plasma and serum are not acceptable.
Requisition Form: Cytogenetics Lab Neoplasia Diagnosis Form #132
Required Information: Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), reason for referral, clinician name and UPIN/NPI, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label.
Results Include: BCR/ABL1 fusion transcript detected/not detected. Specific transcript reported.
Limitations: This assay is designed to detect six major (p210) and four minor (p190) BCR-ABL1 fusion transcripts. Rare BCR-ABL1 fusions involving other breakpoints are not detectable by this test. This assay will not detect BCR-ABL1 fusion gene transcripts below the limit of detection (LOD). The analytical sensitivity (LOD) of this assay has been determined at 1 BCR-ABL1 positive cell in 1,000 cells, or 0.1%. This test is not intended to detect minimal residual disease. Failure to identify an abnormal clone by RT-PCR does not rule out the presence of other abnormalities in the specimen.
Additional Tests Recommended: Cytogenetic analysis of bone marrow (test 812) is also recommended when considering a diagnosis of chronic myeloid leukemia or acute lymphocytic leukemia.
Additional Comments:
Methodology: Qualitative Reverse-Transcription PCR reflex to Quantitative Real-time RT-PCR (See BCR/ABL1 PCR-M for details on the quantitative method)
Includes: Reverse-Transcription PCR (qualitative with reflex to quantitative assay if appropriate) for the detection of Major (p210) and minor (p190) BCR/ABL1 fusion transcripts associated with t(9;22)(q34;q11.2) recurrent in chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL).
CPT Code: 81206, 81207
Price: For pricing information, please call 608-262-0402.
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