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 chronic lymphocytic leukemia (CLL) and leukemic phase of mantle cell lymphoma (ATM, 12, 13q, 17p, and CCND1/IgH fusion)
Use
This test is a diagnostic test for chronic lymphocytic leukemia. Detection rate is improved from 45% with a chromosome study to 80% with fluorescence in situ hybridization (FISH). Differentiates CLL from MCL.
|
This test is a diagnostic test for chronic lymphocytic leukemia. Detection rate is improved from 45% with a chromosome study to 80% with fluorescence in situ hybridization (FISH). Differentiates CLL from MCL. |
Special Instructions
Indicate pertinent clinical diagnosis and previous cytogenetic studies on the 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 This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. |
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.
|
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, 6 slides with metaphase and/or interphase nuclei or 6 touch preparation slides
|
5 mL whole blood (pediatric), 3 mL bone marrow, fixed-cell pellet from a cytogenetic analysis, 6 slides with metaphase and/or interphase nuclei or 6 touch preparation slides |
Minimum Volume
1 mL whole blood (pediatric), 1 mL bone marrow, fixed-cell pellet from cytogenetic analysis, 3 slides with metaphase and/or interphase nuclei or 3 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, 3 slides with metaphase and/or interphase nuclei or 3 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 |
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.
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.
|
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; decalcified bone core; frozen specimen; quantity not sufficient for analysis
Broken Vacutainer®; broken |
Broken Vacutainer®; broken or stained slides; decalcified bone core; frozen specimen; quantity not sufficient for analysis |
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 510340 | CLL FISH Panel | 510709 | Specimen Type | 31208-2 | ||
| 510340 | CLL FISH Panel | 510687 | Cells Counted | 62361-1 | ||
| 510340 | CLL FISH Panel | 510688 | Cells Analyzed | 62360-3 | ||
| 510340 | CLL FISH Panel | 510689 | FISH Result | 48674-6 | ||
| 510340 | CLL FISH Panel | 510337 | Interpretation | 50398-7 | ||
| 510340 | CLL FISH Panel | 510338 | Director Review: | 48672-0 | ||
| 510340 | CLL FISH Panel | 512123 | 11502-2 | |||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510709 | |||||
| Result Code Name | Specimen Type | |||||
| UofM | ||||||
| Result LOINC | 31208-2 | |||||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510687 | |||||
| Result Code Name | Cells Counted | |||||
| UofM | ||||||
| Result LOINC | 62361-1 | |||||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510688 | |||||
| Result Code Name | Cells Analyzed | |||||
| UofM | ||||||
| Result LOINC | 62360-3 | |||||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510689 | |||||
| Result Code Name | FISH Result | |||||
| UofM | ||||||
| Result LOINC | 48674-6 | |||||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510337 | |||||
| Result Code Name | Interpretation | |||||
| UofM | ||||||
| Result LOINC | 50398-7 | |||||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510338 | |||||
| Result Code Name | Director Review: | |||||
| UofM | ||||||
| Result LOINC | 48672-0 | |||||
| Order Code | 510340 | |||||
| Order Code Name | CLL FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 512123 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 11502-2 |