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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 a paraffin-embedded tissue sample is received, this test will be canceled and automatically reordered by the laboratory as SLL / Small Lymphocytic Lymphoma, FISH, Tissue.
Shipping Instructions
Advise Express Mail or equivalent if not on courier service.
Necessary Information
A reason for testing and a flow cytometry and/or a bone marrow pathology report are requested with each specimen. The laboratory will not reject testing if this information is not provided; however, appropriate testing and/or interpretation may be compromised or delayed in some instances. If not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.
Specimen Required
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Blood
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (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 (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)
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.
This test is performed as panel testing only and will be performed using the following analysis algorithm. Modifications of the FISH probes or chronic lymphocytic leukemia (CLL) algorithm are not allowed for this test.
The panel includes testing for the following abnormalities using the probes listed:
6q-, D6Z1/MYB
11q-, D11Z1/ATM
+12, D12Z3/MDM2
13q-, D13S319/LAMP1
17p-, TP53/D17Z1
t(11;14), CCND1/IGH
Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.
In the absence of CCND1::IGH fusion, when an extra IGH signal is identified, additional testing using the IGH/BCL3 probe set will be considered at the laboratory's discretion to identify a potential IGH::BCL3 fusion [t(14;19)(q32;q13)]. Laboratory discretion may be influenced by available karyotype results and previous CLL FISH testing.
Method Name
Reporting Name
CLL, Diagnostic FISHSpecimen Type
VariesSpecimen Minimum Volume
Blood: 2 mL; Bone marrow: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
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 CLL clone or another neoplastic disorder.
Clinical Reference
1. Dewald GW, Brockman SR, Paternoster SF, et al: Chromosome anomalies detected by interphase FISH: correlation with significant biological features of B-cell chronic lymphocytic leukemia. Br J Haematol. 2003;121:287-295
2. Dohner H, Stilgenbauer S, Benner A, et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med. 2000;343(26):1910-1916
3. Van Dyke DL, Shanafelt TD, Call TG, et al. A comprehensive evaluation of the prognostic significance of 13q deletions in patients with B-chronic lymphocytic leukaemia. Br J Haematol. 2010;148:544-550
4. Shanafelt TD: Predicting clinical outcome in CLL: how and why. Hematology Am Soc Hematol Educ Program. 2009;421-429
5. Van Dyke DL, Werner L, Rassenti LZ, et al. The Dohner fluorescence in situ hybridization prognostic classification of chronic lymphocytic leukaemia (CLL): the CLL Research Consortium experience. Br J Haematol. 2016;173(1):105-113
6. Fang H, Reichard KK, Rabe KG, et al. IGH translocations in chronic lymphocytic leukemia: Clinicopathologic features and clinical outcomes. Am J Hematol. 2019;94(3):338-345
7. Huh YO, Schweighofer CD, Ketterling RP, et al. Chronic lymphocytic leukemia with t(14;19)(q32;q13) is characterized by atypical morphologic and immunophenotypic features and distinctive genetic features. Am J Clin Pathol. 2011;135(5):686-696
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 |
Forms
If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.