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Test Code LABSSLFT Small Lymphocytic Lymphoma, FISH, Tissue

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic Mayo Test ID
Small Lymphocytic Lymphoma, FISH, Tissue LABSLLFT SLL SLL

 


Ordering Guidance


This test does not include a pathology consultation. If a pathology consultation is requested, order PATHC / Pathology Consultation and the appropriate fluorescence in situ hybridization test (FISH) test will be added and performed at an additional charge.

 

Mayo Hematopathology Consultants are involved in both the preanalytic (tissue adequacy and probe selection, when applicable) and postanalytic (interpretation of FISH results in context of specific case, when applicable) phases.

 

This test is not appropriate for testing blood and bone marrow from patients with chronic lymphocytic leukemia. See CLLDF / Chronic Lymphocytic Leukemia (CLL), Diagnostic FISH, Varies or CLLMF / Chronic Lymphocytic Leukemia (CLL), Specified FISH, Varies.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. A pathology report is required for testing to be performed. If not provided, appropriate testing and/or interpretation may be compromised or delayed. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.

2. The following information must be included in the report provided:  

-Patient name 

-Block number- must be on all blocks, slides, and paperwork  

-Date of collection 

-Tissue source 

3. 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.



Specimen Required


Submit only 1 of the following specimens:

Preferred 

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used. 

 

Acceptable 

Specimen Type: Tissue slides

Slides:1 Hematoxylin and eosin-stained (H and E) stained and 10 unstained 

Collection Instructions: Submit 1 slide stained with H and E and 10 consecutive, unstained, positively charged, unbaked slides with 5-micron-thick sections of the tumor tissue.


Useful For

Recurrent common chromosome abnormalities in patients with small lymphocytic lymphoma (SLL)

 

Distinguishing patients with 11;14 translocations who have mantle cell lymphoma (MCL) from patients who have SLL

 

Detecting patients with atypical SLL or other forms of B-cell lymphoma associated with translocations between IGH and BCL3

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
_PRAG Probe, Each Additional (SLL) 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 all reflex or additional probes performed. No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.

 

This test may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question, including the standard small lymphocytic lymphoma (SLL) FISH panel and the individual SLL FISH probes (per client request).

 

If the patient is being evaluated for known abnormalities, targeted probes must be listed in the probe request field. If no specific panel or FISH probes are indicated, the standard panel will be performed.

 

The standard SLL FISH panel includes testing for the following abnormalities, using the FISH probes listed:

6q-, D6Z1/MYB

11q-, D11Z1/ATM

+12, D12Z3/MDM2

13q-, D13S319/LAMP1

17p-, TP53/D17Z1

t(11;14), CCND1::IGH

 

When 3 IGH signals are identified suggesting an IGH rearrangement and no fusion with CCND1 is observed, additional testing with the t(14;19)(q32;q13) IGH::BCL3 FISH probe will be performed.

 

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

SLL, FISH, Tissue

Specimen Type

Tissue

Specimen Minimum Volume

Slides: 1 Hematoxylin and eosin-stained and 6 unstained

Specimen Stability Information

Specimen Type Temperature Time Special Container
Tissue Ambient (preferred)
  Refrigerated 

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

Small lymphocytic lymphoma (SLL) is the nonleukemic form of chronic lymphocytic leukemia (CLL), one of the most common leukemias in adults. The most frequently seen cytogenetic abnormalities in SLL involve chromosomes 6, 11, 12, 13 and 17. These are detected and quantified using the SLL fluorescence in situ hybridization (FISH) panel.

 

Cytogenetics has proven to be a reliable predictor of outcome for patients with CLL. It is unknown if SLL has the same prognostic significance when these genetic abnormalities are observed.

 

This FISH test detects an abnormal clone in approximately 65% of patients with SLL. Patients with t(11;14)(q13;q32) associated with CCND1::IGH fusion, have mantle cell lymphoma which can be distinguished from SLL and other B-cell lymphomas with this assay. Patients with t(14;19)(q32;q13.3) associated with IGH::BCL3 fusion, may have an atypical form of SLL or another B-cell lymphoma.

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.

 

A positive result is not diagnostic for small lymphocytic lymphoma but may provide relevant prognostic information.

 

The absence of an abnormal clone does not rule out the presence of an SLL 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.

 

Fixatives other than formalin (eg, Prefer, Bouin's) may not be successful for fluorescence in situ hybridization (FISH) assays. Non-formalin fixed samples will not be rejected.

 

Paraffin-embedded tissues that have been decalcified may not be successful for FISH analysis. The success rate of FISH studies on decalcified tissue is approximately 50%, but FISH will be attempted if sufficient tumor is present for analysis.

 

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. A dual-color, dual-fusion (D-FISH) strategy probe set is used to detect CCND1::IGH rearrangements and, for reflex testing, to identify IGH::BCL3 rearrangements. Paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin (H and E)-stained slide is performed by a pathologist. Using the H and E-stained slide as a reference, target areas are etched with a diamond-tipped engraving tool on the back of the unstained slide to be assayed. For each probe set, the probes are hybridized to the appropriate target areas and 2 technologists each analyze 50 interphase nuclei (100 total). 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

Slides and H and &E used for analysis are retained by the laboratory in accordance to with CAP and NYSregulatory requirements. Client provided paraffin blocks and extra unstained slides (if provided) will be returned after testing is complete.

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

88377-if 1 probe set

88377 x 2-if 2 probe sets

88377 x 3-if 3 probe sets

88377 x 4-if 4 probe sets

88377 x 5-if 5 probe sets

88377 x 6-if 6 probe sets

88377 x 7-if 7 probe sets

88377 x 8-if 8 probe sets

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SLL SLL, FISH, Tissue 103621-9

 

Result ID Test Result Name Result LOINC Value
603129 Result Summary 50397-9
603130 Interpretation 69965-2
603131 Result Table 93356-4
603132 Result 62356-1
GC038 Reason for Referral 42349-1
603133 Specimen 31208-2
603134 Source 31208-2
603135 Tissue ID 80398-1
603136 Method 85069-3
603137 Additional Information 48767-8
603138 Disclaimer 62364-5
603139 Released By 18771-6

Forms

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