Sign in →

Test Code CLLMF Chronic Lymphocytic Leukemia, Specified FISH, Varies


Ordering Guidance


This test is intended for instances when limited chronic lymphocytic leukemia (CLL) fluorescence in situ hybridization (FISH) probes are needed based on specific abnormalities or abnormalities identified in the diagnostic sample.

 

If targeted FISH probes are not included with this test order, test processing will be delayed and the test may be canceled and automatically reordered by the laboratory as CLLDF / Chronic Lymphocytic Leukemia, Diagnostic FISH, Varies.

 

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 should be submitted 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.


Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Secondary ID

610724

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
CLLMB Probe, Each Additional (CLLMF) No, (Bill Only) No

Testing Algorithm

This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for additional probe sets performed.

 

This is not intended as a panel test and the desired probes must be specified upon order. If the patient is being evaluated for known abnormalities, targeted probes must be listed in the probe request field.

 

When specified, any of the following probes will be performed:

6q-, D6Z1/MYB

11q-, D11Z1/ATM

+12, D12Z3/MDM2

13q-, D13S319/LAMP1

17p-, TP53/D17Z1

t(11;14), CCND1/IGH

t(14;19), IGH/BCL3

 

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.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

CLL, Specified FISH

Specimen Type

Varies

Specimen Minimum Volume

Blood: 2 mL; Bone marrow: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
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 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 chronic lymphocytic leukemia clone or another neoplastic disorder.

Cautions

This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.

Supportive Data

Each probe was independently tested and verified on unstimulated peripheral blood and bone marrow specimens. Normal cutoffs were calculated based on the results of at least 25 normal specimens. In addition, each probe set was evaluated in a blinded fashion to confirm the probe set detected the abnormality it was designed to detect.

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

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. A dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe set is used to detect CCND1::IGH rearrangements and for reflex testing to identify IGH::BCL3 rearrangements. For enumeration 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 days

Specimen Retention Time

4 weeks

Performing 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

88271x2, 88275, 88291-FISH Probe, Analysis, Interpretation; 1 probe set

88271x2, 88275-FISH Probe, Analysis; each additional probe set (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CLLMF CLL, Specified FISH 101920-7

 

Result ID Test Result Name Result LOINC Value
610725 Result Summary 50397-9
610726 Interpretation 69965-2
610727 Result Table 93356-4
610728 Result 62356-1
GC091 Reason for Referral 42349-1
GC093 Probes Requested 78040-3
GC092 Specimen 31208-2
610729 Source 31208-2
610730 Method 85069-3
610731 Additional Information 48767-8
610732 Disclaimer 62364-5
610733 Released by 18771-6