Test Catalog

Test Id : SLL

Small Lymphocytic Lymphoma, FISH, Tissue

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with small lymphocytic lymphoma (SLL) and other low-grade B-cell lymphomas

 

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

Highlights

This assay detects chromosome abnormalities observed in paraffin-embedded tissue samples from patients with small lymphocytic lymphoma.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
_PRAG Probe, Each Additional (SLL) No, Bill Only No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

 

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

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

If the patient is being tracked for known abnormalities, indicate which probes should be used.

 

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

 

When an IGH rearrangement is identified, reflex testing with the t(14;19)(q32;q13) IGH/BCL3 FISH probe will be performed.

Method Name
A short description of the method used to perform the test

Fluorescence In Situ Hybridization (FISH)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

SLL, FISH, Tissue

Aliases
Lists additional common names for a test, as an aid in searching

CLL

trisomy 12

11q- (11q deletion) or ATM

13q- (13q deletion) or LAMP1

17p- (17p deletion) or TP53

6q- (6q deletion) or MYB

Nonleukemic form of chronic lymphocytic leukemia (CLL)

SLL

Small lymphocytic leukemia (SLL)

t(11;14)(q13;q32)-CCND1/IGH

t(14;19)(q32;q13)-IGH/BCL3

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

 

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

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

If the patient is being tracked for known abnormalities, indicate which probes should be used.

 

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

 

When an IGH rearrangement is identified, reflex testing with the t(14;19)(q32;q13) IGH/BCL3 FISH probe will be performed.

Specimen Type
Describes the specimen type validated for testing

Tissue

Ordering Guidance

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

A reason for referral and pathology report are required in order for testing to be performed. Send information with specimen. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Specimen Type: Lymph node

Preferred: Tissue block

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

 

Acceptable: Slides

Collection Instructions: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

 

Specimen Type: Solid tumor

Preferred: Tissue block

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

 

Acceptable: Slides

Collection Instructions: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required.

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with small lymphocytic lymphoma (SLL) and other low-grade B-cell lymphomas

 

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

 

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

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

If the patient is being tracked for known abnormalities, indicate which probes should be used.

 

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

 

When an IGH rearrangement is identified, reflex testing with the t(14;19)(q32;q13) IGH/BCL3 FISH probe will be performed.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Small lymphocytic lymphoma (SLL) is the nonleukemic form of chronic lymphocytic leukemia (CLL), the most common adult leukemia in North America. The most common cytogenetic abnormalities detected in CLL are deletions of 6q, 11q, 13q, and 17p, trisomy 12, and the occasional occurrence of IGH translocations at 14q32. 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 low-grade B-cell lymphoma.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.

 

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 a neoplastic disorder.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test is not approved by the U.S. 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) may not be successful for FISH assays, however nonformalin-fixed samples will not be rejected.

 

Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.

Supportive Data

Each probe was independently tested on a set of 62 formalin-fixed, paraffin-embedded tissue specimens from patients diagnosed with small lymphocytic lymphoma, splenic marginal zone lymphoma, or lymphoplasmacytic lymphoma and a set of noncancerous lymph node specimens. Normal cutoffs were calculated based on the results from 25 normal specimens. For each probe set, a series of chromosomally abnormal specimens were evaluated to confirm each probe set detected the anomaly it was designed to detect.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. Swerdlow SH, Campo E, Harris NL eds. IARC; 2017

2. Shanafelt TD: Predicting clinical outcome in CLL: how and why. Hematology Am Soc Hematol Educ Program. 2009;421-429

3. 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;173:105-113

Method Description
Describes how the test is performed and provides a method-specific reference

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 BCL3/IGH 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 etcher 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) with the results expressed as the percent abnormal nuclei.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

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

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports