PML/RARA Fusion, t(15;17)(q24;q21), FISH
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| WSLH Department: | Cytogenetics |
| WSLH Test Code: | 881F66 |
| Day(s) Performed: | Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM |
| Turn-around Time: | Approximately 4-6 days, RUSH results for new diagnoses available in 1-2 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM) |
| Recommended Uses: | Detection of the PML/RARA fusion associated with APL. Aids in diagnosis and prognosis of hematologic disorders and for monitoring disease after treatment or bone marrow transplant. May be performed in conjunction with other FISH assays, chromosome analysis, RT-PCR, or as an independent test. |
| Contraindications: | |
| Additional Tests Performed: |
| Patient Preparations: | |
| Specimen Requirements: | Bone marrow: 0.5-1.0 ml early aspirate bone marrow OR Blood: 1-2 ml whole blood collected in sodium heparin 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. |
| 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. Rinse the syringe to be used for aspiration by drawing sodium heparin solution (1000 USP units/ml) into the syringe and then expelling all the heparin solution (over-heparinization is toxic to the cells). Transfer the marrow to a sterile, sodium heparin vacuum type tube for delivery to State Lab. If an aspirate is unsuccessful, a 10mm bone core biopsy may be submitted in a sterile transport medium with sodium heparin. ** Blood: Draw blood using aseptic techniques into a sterile sodium heparin 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: | Bone marrow/blood that is clotted or hemolyzed is not acceptable. Bone marrow/blood must not be frozen. Plasma and serum are not acceptable. |
| Requisition Form: |
Cytogenetics Lab Neoplasia Diagnosis Form #132
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| 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: | Number of nuclei examined, percent positive for fusion, and the reference range for false positives based on the average number of cells with an abnormal signal pattern in two hundred control cells. Result written using current International System for Human Cytogenetic Nomenclature (ISCN) and interpretation of results. |
| Limitations: | Failure to identify an abnormal clone by FISH does not rule out the presence of other abnormalities in the specimen. |
| Additional Tests Recommended: | |
| Additional Comments: | If FISH assay is not performed in conjunction with chromosome analysis there is an additional charge for processing the specimen. |
| Methodology: | Fluorescence in situ hybridization performed on interphase nuclei using dual fusion DNA probes (LSI PML/RARA dual color, dual fusion; Abbott Molecular) specific for the PML gene in 15q24 and the RARA gene in 17q21. |
| Includes: | FISH analysis of 200 interphase cells for fusion of the PML and RARA genes |
| CPT Code: | 88271x2, 88275 |
| Price: | For pricing information, please call 608-262-0402. |