Test Details
Methodology
Fluorescence in situ hybridization (FISH)
Result Turnaround Time
3 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
Fluorescence in situ hybridization (FISH) for acute lymphoblastic leukemia (ALL), targeting rearrangement of BCR-ABL, TCF3, KMT2A (MLL), ETV6/RUNX1, and numerical changes of 4, 10, 17, and CDKN2A deletion.
Use
This test is a diagnostic and prognostic test for acute lymphoblastic leukemia in the pediatric population. Detection rate is improved from 50% with a chromosome study to 90% with FISH.
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This test is a diagnostic and prognostic test for acute lymphoblastic leukemia in the pediatric population. Detection rate is improved from 50% with a chromosome study to 90% with FISH. |
Special Instructions
Indicate pertinent clinical diagnosis and previous cytogenetic studies on the test request form.
Limitations
Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Molecular mutations or chromosomal alterations not targeted by the probe |
Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected. This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. |
Specimen Requirements
Specimen
Whole blood, bone marrow, CSF, fixed-cell pellet from a cytogenetic analysis, slide with metaphase and/or interphase nuclei or bone marrow touch preparation slides are acceptable for testing.
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Whole blood, bone marrow, CSF, fixed-cell pellet from a cytogenetic analysis, slide with metaphase and/or interphase nuclei or bone marrow touch preparation slides are acceptable for testing. |
Volume
5 mL whole blood (pediatric), 3 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, 12 slides with metaphase and/or interphase nuclei or 12 touch preparation slides
5 mL |
5 mL whole blood (pediatric), 3 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, 12 slides with metaphase and/or interphase nuclei or 12 touch preparation slides |
Minimum Volume
1 mL whole blood (pediatric), 1 mL bone marrow, fixed-cell pellet from cytogenetic analysis, 6 slides with metaphase and/or interphase nuclei or 6 touch preparation slides (Note: Minimum volumes may not allow for repeat testing.)
1 mL |
1 mL whole blood (pediatric), 1 mL bone marrow, fixed-cell pellet from cytogenetic analysis, 6 slides with metaphase and/or interphase nuclei or 6 touch preparation slides (Note: Minimum volumes may not allow for repeat testing.) |
Container
Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal). For samples with shared karyotype (510999) and any FISH study in the same tube, EDTA is not recommended due to the growth inhibition in cell culture. Adjust tube size to sample volume to avoid heparin toxicity.
Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal). Adjust tube size to sample volume to avoid heparin toxicity. |
Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal). For samples with shared karyotype (510999) and any FISH study in the same tube, EDTA is not recommended due to the growth inhibition in cell culture. Adjust tube size to sample volume to avoid heparin toxicity. |
Collection Instructions
Utilize sterile technique and Labcorp transport kits when possible.
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Utilize sterile technique and Labcorp transport kits when possible. |
Storage Instructions
Transport to the testing laboratory at room temperature; use of a cool pack or a Labcorp transport kit is acceptable. Do not allow samples to overheat or freeze.
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Transport to the testing laboratory at room temperature; use of a cool pack or a Labcorp transport kit is acceptable. Do not allow samples to overheat or freeze. |
Causes for Rejection
Broken Vacutainer®; broken or stained slides; paraffin blocks; paraffin slides; decalcified bone cores; frozen specimen; quantity not sufficient for analysis
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
510324 | FISH Pediatric ALL Oncology | 510709 | Specimen Type | 31208-2 | ||
510324 | FISH Pediatric ALL Oncology | 510687 | Cells Counted | 62361-1 | ||
510324 | FISH Pediatric ALL Oncology | 510688 | Cells Analyzed | 62360-3 | ||
510324 | FISH Pediatric ALL Oncology | 510689 | FISH Result | 48674-6 | ||
510324 | FISH Pediatric ALL Oncology | 510326 | Interpretation | 50398-7 | ||
510324 | FISH Pediatric ALL Oncology | 510327 | Director Review: | 48672-0 | ||
510324 | FISH Pediatric ALL Oncology | 512123 | 11502-2 | |||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 510709 | |||||
Result Code Name | Specimen Type | |||||
UofM | ||||||
Result LOINC | 31208-2 | |||||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 510687 | |||||
Result Code Name | Cells Counted | |||||
UofM | ||||||
Result LOINC | 62361-1 | |||||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 510688 | |||||
Result Code Name | Cells Analyzed | |||||
UofM | ||||||
Result LOINC | 62360-3 | |||||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 510689 | |||||
Result Code Name | FISH Result | |||||
UofM | ||||||
Result LOINC | 48674-6 | |||||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 510326 | |||||
Result Code Name | Interpretation | |||||
UofM | ||||||
Result LOINC | 50398-7 | |||||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 510327 | |||||
Result Code Name | Director Review: | |||||
UofM | ||||||
Result LOINC | 48672-0 | |||||
Order Code | 510324 | |||||
Order Code Name | FISH Pediatric ALL Oncology | |||||
Order Loinc | ||||||
Result Code | 512123 | |||||
Result Code Name | ||||||
UofM | ||||||
Result LOINC | 11502-2 |