PML/RARA Fusion Transcript, t(15;17)(q24;q21), RT-PCR Print

WSLH Department: Cytogenetics
WSLH Test Code: 887M35
Day(s) Performed: Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM
Turn-around Time: Approximately 2-4 days, for RUSH cases results are available in 1-2 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM)
Recommended Uses: Aids in diagnosis and detection of PML/RARA fusion transcripts associated with APL. May be performed in conjunction with FISH or chromosome analysis or as an independent test. Not intended for minimal residual disease monitoring.
Contraindications:
Additional Tests Performed:
Patient Preparations:
Specimen Requirements: Bone marrow: 0.5-1.0 ml early aspirate bone marrow
OR
Blood: 10 ml (preferred) 5 ml (minimum) 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 to 48 hours of collection. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
Collection Kit/Container:
Collection Instructions: ** Bone marrow: 0.5-1.0 ml bone marrow from the 1st or 2nd aspirate. Material submitted for cytogenetic analysis must be from an early aspirate to avoid dilution with blood. 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. Invert tube to mix. If using larger tubes, draw full tube 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: Positive/negative for PML-RARA fusion transcripts. If positive, splice breakpoints reported.
Limitations: This assay detects, but does not differentiate, the following PML-RARA fusion gene transcripts: long (L-form, bcr-1), variant (V-form, bcr-2) and short (S-form, bcr3). This assay will not detect PML-RARA fusion transcripts with rare PML breakpoints or rare variant translocations involving RARA and a gene other than PML. This assay will not detect PML-RARA fusion gene transcripts below the limit of detection (LOD). The analytical sensitivity (LOD) of this assay has been determined at 0.1%, or approximately 10 fusion transcripts in 100 ng total RNA.
Additional Tests Recommended:
Additional Comments:
Methodology: Qualitative Reverse-Transcription PCR: Total RNA is extracted from whole blood or bone marrow. One-step reverse transcription of mRNA and PCR amplification is performed with translocation specific primers and probe designed to detect, but not differentiate, three PML-RARA fusion gene transcripts: long (L-form, bcr-1), variant (V-form, bcr-2) and short (S-form, bcr3). The reaction contains a pair of internal control primers (ABL1). In addition, positive, low positive, and negative (reagent) controls are run with the patient sample. The analytical sensitivity (limit of detection) of this assay has been determined at 0.1%, or approximately 10 fusion transcripts in 100 ng total RNA. The clinical (diagnostic) sensitivity is >98%.
Includes: Reverse-Transcription PCR for the detection of PML/RARA fusion transcripts associated with t(15;17)(q24;q21) recurrent in APL.
CPT Code: 81315
Price: For pricing information, please call 608-262-0402.
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