|ALK Rearrangement, FISH|
| WSLH Department:|| Cytogenetics|
|WSLH Test Code:||882F87|
|CPT Code:||88271, 88275|
|Price:||For pricing information, please call 608-262-0402.|
|Includes:||FISH analysis of 50 cells (FFPE Lung specimens) or 200 interphase (hematologic evaluations) for rearrangement of the ALK gene|
|Methodology:||Dual color FISH analysis is performed on interphase nuclei (nuc ish) using a break-apart DNA probe (LSI ALK dual color, rearrangement; Vysis, Inc) specific for the ALK gene in 2p23. This probe is designed to detect rearrangements of the ALK gene in formalin-fixed paraffin embedded (FFPE) non-small cell lung cancer tissue specimens. A manual scoring system is used to evaluate tumor cells and determine if a cell is negative or positive. Probes are scored as split if there is a gap that is greater than two signal widths between the red and green signals.|
Classification of case result as positive or negative is according to manufacturer’s instructions:
A sample is considered negative if <5 cells out of 50 (<10%) are positive.
A sample is considered positive if >25 cells out of 50 (>50%) are positive.
A sample is considered equivocal, if 5 to 25 cells (10 to 50%) are positive.
|Availability:||Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM|
|Turn-around Time:||Approximately 4-8 days, with an average of 6 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM)|
|Recommended Uses:||This is an FDA-approved test for the detection of rearrangements of the ALK gene associated with adenocarcinomas of the lung. Aids in diagnosis of hematologic disorders (anaplastic large cell lymphoma) and for monitoring disease after treatment or bone marrow transplant. May be performed in conjunction with other FISH assays, chromosome analysis (for bone marrow, blood, and fresh tissue only) or as an independent test.|
|Specimen Requirements:||0.5-1.0 ml early aspirate bone marrow collected in sodium heparin|
1-2 ml whole blood collected in sodium heparin vacuum type tube
Fresh tissue: At least 0.3cm cubed section of tumor; avoid areas of necrosis.
Paraffin embedded tissue: Five 4-micron sections on immunohistochemistry slides, the middle section stained with H&E.
|Collection Kit/Container:|| |
|Patient Preparation:|| |
|Collection Instructions:||**Bone marrow: 0.5-1.0ml bone marrow from 1st or 2nd aspirate. Material submitted for cytogenetic analysis must be from an early aspirate to avoid dilution with blood. Draw sodium heparin solution (1000 USP units/ml) into the syringe to be used for aspiration and then expel (over-heparinization is toxic to the cells). Transfer the marrow to a sterile, Na-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 Na-Heparin. **Blood: Draw blood using aseptic techniques into a sterile Na-Heparin vacuum type tube. Invert tube to mix. If using larger tubes, draw to full volume to avoid over-treatment with heparin. **Fresh tissue: A 0.3-1.0cm cubed section collected using aseptic procedures; avoid areas of necrosis. Place the specimen in a sterile tissue vial containing transport media. **FFPE tissue: Tissue specimen should be fixed in 10% neutral buffered formalin for 6-48 hours.|
|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:||Bone marrow/blood that is clotted or hemolyzed is not acceptable. Samples must not be frozen. Plasma and serum are not acceptable. FFPE tissue specimen must not be de-calcified.|
|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:||Number of nuclei examined, percent positive for rearrangement, and the reference range for false positives based on manufacturer specifications in accordance with FDA approval. Result written using current International System for Human Cytogenetic Nomenclature (ISCN) and interpretation of results.|
|Limitations:||Detects rearrangements involving this gene; the translocation partner chromosome cannot be determined by this test. 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.|
|Additional Tests Performed:|| |