BCR/ABL1 PCR -M, t(9;22)(q34;q11.2), Monitoring

BCR/ABL1 PCR -M, t(9;22)(q34;q11.2), Monitoring
WSLH Department: Cytogenetics
WSLH Test Code:893M51 or 893M52
CPT Code:Major-81206, Minor-81207
Price:For pricing information, please call 608-262-0402.
Includes:Quantitative RT-PCR for the detection of Major BCR/ABL1 fusion transcripts e13a2 and e14a2 or minor BCR/ABL1 fusion transcript e1a2 associated with t(9;22)(q34;q11.2) recurrent in chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL). Results for Major transcripts are calibrated to an international standard for ease of interpretation and calculation of log reduction for major molecular response (MMR).
Methodology:The QuantideX® qPCR BCR-ABL IS (Major) Kit uses multiplex reverse transcription-PCR (RT-PCR) in combination with real-time hydrolysis probe technology to provide simultaneous amplification and detection of two BCR-ABL1 fusion transcripts (e13a2 and e14a2) and ABL1 (an endogenous control) using total RNA extracted from human white blood cells. The percent ratio of BCR-ABL1 to ABL1 is expressed on the International Scale (%IS). The molecular reduction (MR, a logarithmic decrease from the common baseline of 100%IS or MR0) is determined using a set of calibrators included in the kit. The MR value is the log10 reduction from the internationally standardized baseline, defined as 100%IS (White et al. 2010, PMID: 20720184). The QuantideX® qPCR BCR-ABL IS Kit is a modified FDA-approved assay (modified for acceptable specimen type).

The QuantideX® qPCR BCR-ABL minor Kit provides simultaneous amplification and detection of BCRABL1 fusion transcript e1a2 and ABL1 (an endogenous control) using total RNA extracted from human white blood cells. The test uses multiplex reverse transcription-PCR (RT-PCR) in combination with real-time hydrolysis probe technology.
Availability:Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM
Turn-around Time:Approximately 5-7 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM)
Recommended Uses:Monitoring disease after treatment or bone marrow transplant; comparison of current level of transcript to standard calibrator to determine log reduction.
Contraindications: 
Specimen Requirements:**1.0-2.0 ml early aspirate bone marrow

OR

**5-10 ml whole blood collected in EDTA vacuum type
Collection Kit/Container: 
Patient Preparation: 
Collection Instructions:**Blood: Draw blood using aseptic techniques into a sterile EDTA vacuum type tube. Invert tube to mix. If using larger tubes, draw to full volume to avoid over-treatment with anticoagulant.

**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.
Specimen Handling and 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.
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 and expressed as an International Scale Normalized Copy Number (IS-NCN). Calculation of the log reduction based on the international scale.
Limitations:Major: This assay is only designed to detect, but not distinguish between the BCR-ABL1 fusion transcripts e13a2 (b2a2) and e14a2 (b3a2). BCR-ABL1 p190 and p130 fusion transcripts, other minor or micro breakpoints, microdeletions, or mutations are not detected by this test. A negative result does not exclude the presence of BCR-ABL1 p210 fusion transcripts that are below the test limit of detection.

Minor: This assay is only designed to detect the BCR-ABL1 fusion transcript e1a2. The ability to detect other fusion transcripts has not been evaluated. The test does not accurately detect Major or micro breakpoints, microdeletions, or mutations. Some specimens with very high levels of BCR-ABL1 Major transcript (e13a2 and/or e14a2) may be displayed as a low positive. Conversely, some specimens without confirmed presence of BCR-ABL1 minor transcript (e1a2) may be displayed as a very low positive. Some specimens with very low levels of BCR-ABL1 transcript (below 0.0025%) may be displayed as Undetected (Sufficient ABL). Hence, an Undetected result does not preclude the presence of low levels of leukemic cells in the specimen.
Additional Tests Recommended:Qualitative testing for BCR/ABL1 fusion transcripts should be done prior to quantitative testing. The qualitative test will detect additional transcript sizes that are not detectable using this quantitative method.
Additional Comments: 
Additional Tests Performed: 

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