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: 
Price: 
Includes:Quantitative RT-PCR for the detection of Major BCR/ABL1 fusion transcripts b3-a2 and b2-a2 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:**(CPT Codes: Major-81206, Minor-81207)** Quantitative realtime RT-PCR (QRT-PCR) Reverse transcription of mRNA is performed using random hexamer/nonamers, the resulting cDNA is PCR amplified using Major or minor breakpoint translocation specific primers and probe (Ipsogen, Inc.) in realtime for quantification using the ABL1 gene internal control and the international standard calibrator for Major breakpoints.
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:Monitoring disease after treatment or bone marrow transplant; comparison of current level of transcript to standard calibrator to determine log reduction.
Contraindications: 
Specimen Requirements:5-10 ml whole blood collected in EDTA vacuum type tube
Collection Kit/Container: 
Patient Preparation: 
Collection Instructions: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.
Specimen Handling and Transport:Store and transport specimens at room temperature (may transport with coolant during hot, >85 degrees F weather). 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). NCN = BCL-ABL fusion copies/ ABL copies x 100). IS-NCN= NCNsample x IS-MMR-Calibrator value/ NCNcalibrator. Calculation of the log reduction based on the international scale: log[IS-NCN x100].
Limitations:This assay is designed to detect 2 splice (b2a2 and b3a2) variants for the p210 transcript and one variant (e1a2) for the p190 transcript A negative result does not exclude the presence of BCR/ABL1 fusion transcripts that are below the test limit of detection, which has been determined at 1 BCR/ABL1 positive cell in 100,000 cells, or 0.001%. Major Molecular Response is considered a log reduction of 3. A decrease in log reduction of 1 log or greater may indicate loss of response. Failure to identify an abnormal clone by RT-PCR does not rule out the presence of other abnormalities 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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