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HelpTest Code CLLDF Chronic Lymphocytic Leukemia, Diagnostic FISH, Varies
Ordering Guidance
This test is intended for instances when the entire chronic lymphocytic leukemia (CLL) fluorescence in situ hybridization (FISH) panel is needed.
If targeted CLL FISH probes are preferred, order CLLMF / Chronic Lymphocytic Leukemia, Specified FISH, Varies and request specific probes for targeted abnormalities.
For testing paraffin-embedded tissue specimens from patients with CLL or small lymphocytic lymphoma, order SLL / Small Lymphocytic Lymphoma, FISH, Tissue. If a paraffin-embedded tissue sample is submitted for this test, this test will be canceled and SLL will be added and performed as the appropriate test.
Shipping Instructions
Advise Express Mail or equivalent if not on courier service.
Necessary Information
1. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.
2. A flow cytometry and/or a bone marrow pathology report should be submitted with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed.
Specimen Required
Submit only 1 of the following specimens:
Preferred
Specimen Type: Whole blood
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (sodium heparin) or lavender top (EDTA)
Specimen Volume: 6 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood in original tube. Do not aliquot.
Acceptable
Specimen Type: Bone marrow
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (sodium heparin) or lavender top (EDTA)
Specimen Volume: 2 to 3 mL
Collection Instructions:
1. It is preferable to send the first aspirate from the bone marrow collection.
2. Invert several times to mix bone marrow.
3. Send bone marrow in original tube. Do not aliquot.
Useful For
Detecting recurrent common chromosome abnormalities in patients with chronic lymphocytic leukemia (CLL) using a laboratory-designated probe set algorithm
Distinguishing patients with 11;14 translocations who have the leukemic phase of mantle cell lymphoma from patients who have CLL
Detecting patients with atypical CLL with translocations between IGH and BCL3
Evaluating specimens in which chromosome studies are unsuccessful
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CLLDB | Probe, Each Additional (CLLDF) | No, (Bill Only) | No |
Testing Algorithm
This test includes a charge for the probe application, analysis, and professional interpretation of results for 6 probe sets (12 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.
This test is performed as panel testing only using the following analysis algorithm.
The diagnostic chronic lymphocytic leukemia (CLL) FISH panel includes testing for the following abnormalities using the FISH probes listed:
6q-, D6Z1/MYB probe set
11q-, D11Z1/ATM probe set
+12, D12Z3/MDM2 probe set
13q-, D13S319/LAMP1 probe set
-17/17p-, TP53/D17Z1 probe set
t(11;14)(q13;q32) or IGH::CCND1 fusion, CCND1/IGH probe set
Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes used will have the results included within the final report and will be performed at an additional charge. In the following situations, additional (reflex) testing may be performed at the laboratory's discretion and may be influenced by available karyotype results or other FISH testing.
In the absence of IGH::CCND1 fusion, when an extra IGH signal is identified, testing using the IGH/BCL3 probe set to identify a potential IGH::BCL3 fusion, t(14;19)(q32;q13) may be performed.
In the absence of IGH::CCND1 fusion, when an extra or atypical CCND1 signal is identified, testing using the CCND1 break-apart probe set to identify a potential variant translocation involving CCND1, t(11;var)(q13;?) may be performed.
Method Name
Reporting Name
CLL, Diagnostic FISHSpecimen Type
VariesSpecimen Minimum Volume
Whole blood: 2 mL; Bone marrow: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Ambient (preferred) | |
| Refrigerated | ||
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
Chronic lymphocytic leukemia (CLL) is one of the most common leukemias in adults. The most frequently seen cytogenetic abnormalities in CLL involve chromosomes 6, 11, 12, 13, and 17. These are detected and quantified using the CLL fluorescence in situ hybridization (FISH) panel.
Use of CpG-oligonucleotide mitogen will identify an abnormal CLL karyotype in at least 80% of cases. This mitogen is added to cultures when chromosome analysis is ordered and the reason for testing is B-cell lymphoproliferative disorders (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow and CHRHB / Chromosome Analysis, Hematologic Disorders, Blood).
This FISH test detects an abnormal clone in approximately 70% of patients with indolent disease and in greater than 80% of patients who require treatment. At least 5% of patients referred for CLL FISH testing have translocations involving the IGH locus. Fusion of IGH with CCND1 is associated with t(11;14)(q13;q32), and fusion of IGH with BCL3 is associated with t(14;19)(q32;q13.3). Patients with t(11;14) usually have the leukemic phase of mantle cell lymphoma. Patients with t(14;19) may have an atypical form of B-CLL or the leukemic phase of a lymphoma.
The prognostic associations for chromosome abnormalities detected by this FISH assay are, from best to worst: 13q-, normal, +12, 6q-, 11q- and 17p-.
Reference Values
An interpretive report will be provided.
Interpretation
A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe set.
The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.
Cautions
This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to clinical and pathologic information.
Fluorescence in situ hybridization (FISH) is not a substitute for conventional chromosome studies because the latter detects chromosome abnormalities associated with other hematological disorders that would go undetected in a targeted chronic lymphocytic leukemia FISH panel test.
If no FISH signals are observed post-hybridization, the case will be released indicating a lack of FISH results.
Method Description
This test is performed using commercially available and laboratory-developed probes. Deletion of chromosomes 6q, 11q, 13q and 17p, and trisomy of chromosome 12 are detected using enumeration strategy probes. Rearrangements involving CCND1 are detected using a dual-color break-apart (BAP) strategy probe. A dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe set is used to detect IGH::CCND1 rearrangements and for reflex testing to identify IGH::BCL3 rearrangements. For enumeration and BAP strategy probe sets, 100 interphase nuclei are scored; 200 interphase nuclei are scored when D-FISH probes are used. All results are expressed as the percent abnormal nuclei.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
7 to 10 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88271x12, 88275x6, 88291-FISH Probe, Analysis, Interpretation; 6 probe sets
88271x2, 88275-FISH Probe, Analysis; each additional probe set (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CLLDF | CLL, Diagnostic FISH | 101788-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 610714 | Result Summary | 50397-9 |
| 610715 | Interpretation | 69965-2 |
| 610716 | Result Table | 93356-4 |
| 610717 | Result | 62356-1 |
| GC088 | Reason for Referral | 42349-1 |
| GC089 | Specimen | 31208-2 |
| 610718 | Source | 31208-2 |
| 610719 | Method | 85069-3 |
| 610720 | Additional Information | 48767-8 |
| 610721 | Disclaimer | 62364-5 |
| 610722 | Released by | 18771-6 |