Test Id : SLL
Small Lymphocytic Lymphoma, FISH, Tissue
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting, at diagnosis, recurrent common chromosome abnormalities in patients with small lymphocytic lymphoma (SLL) in paraffin-embedded tissue specimens
Distinguishing patients with 11;14 translocations who have mantle cell lymphoma from patients who have SLL
Detecting patients with atypical SLL with translocations between IGH and BCL3
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 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 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 may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question.
1. Standard (diagnostic) small lymphocytic lymphoma (SLL) FISH panel
2. Individual SLL FISH probes chosen, per client request, from probes listed below
If individual SLL FISH probes are needed, the specific probes requested must be noted on the request form or in the reason for referral. If no FISH probes are indicated, the standard (diagnostic) panel will be performed.
The standard (diagnostic) SLL 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
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 may be performed to identify a potential IGH::BCL3 fusion, t(14;19)(q32;q13).
In the absence of IGH::CCND1 fusion, when an extra or atypical CCND1 signal is identified, testing using the CCND1 break-apart probe set may be performed to identify a potential variant translocation involving CCND1, t(11;var)(q13;?).
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
B-CLL
CLL
6q- (6q deletion) or MYB
11q- (11q deletion) or ATM
t(11;14)(q13;q32.33)-IGH::CCND1 or CCND1/IGH
t(14;19)(q32.33;q13)-IGH::BCL3 or IGH/BCL3
CCND1 (11q13) rearrangement
+12/trisomy 12
13q- (13q deletion) or D13S319
17p- (17p deletion) or TP53
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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 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 may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question.
1. Standard (diagnostic) small lymphocytic lymphoma (SLL) FISH panel
2. Individual SLL FISH probes chosen, per client request, from probes listed below
If individual SLL FISH probes are needed, the specific probes requested must be noted on the request form or in the reason for referral. If no FISH probes are indicated, the standard (diagnostic) panel will be performed.
The standard (diagnostic) SLL 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
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 may be performed to identify a potential IGH::BCL3 fusion, t(14;19)(q32;q13).
In the absence of IGH::CCND1 fusion, when an extra or atypical CCND1 signal is identified, testing using the CCND1 break-apart probe set may be performed to identify a potential variant translocation involving CCND1, t(11;var)(q13;?).
Specimen Type
Describes the specimen type validated for testing
Tissue
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. If a non-paraffin embedded bone marrow or blood sample is received for this test, the test will be canceled and automatically reordered by the laboratory as 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.
4. A list of probes is required if select probes are necessary or if the patient is being tracked for known abnormalities. See Table in Clinical Information.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| GC038 | Reason for Referral |
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:
Preferred:
Specimen Type: Tissue block
Collection Instructions:
1. Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods will be attempted but are less favorable for successful results.
2. Provide fixation method used.
Additional Information:
1. Paraffin embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc).
2. Bone specimens that have been decalcified will be attempted for testing, but the success rate is approximately 50%.
Acceptable:
Specimen Type: Tissue slides
Slides: 1 Hematoxylin and eosin stained and 2 unstained for each probe set
Collection Instructions:
1. Include 1 hematoxylin and eosin-stained slide for the entire test order.
2. If individual probe sets are chosen: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides.
3. If a complete small lymphocytic lymphoma (SLL) panel is ordered, submit 14 consecutive, unstained, 5 micron-thick sections placed on positively charged slides.
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. The minimum volume is sufficient for one attempt at testing.
See Specimen Required.
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
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, at diagnosis, recurrent common chromosome abnormalities in patients with small lymphocytic lymphoma (SLL) in paraffin-embedded tissue specimens
Distinguishing patients with 11;14 translocations who have mantle cell lymphoma from patients who have SLL
Detecting patients with atypical SLL with translocations between IGH and BCL3
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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 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 may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question.
1. Standard (diagnostic) small lymphocytic lymphoma (SLL) FISH panel
2. Individual SLL FISH probes chosen, per client request, from probes listed below
If individual SLL FISH probes are needed, the specific probes requested must be noted on the request form or in the reason for referral. If no FISH probes are indicated, the standard (diagnostic) panel will be performed.
The standard (diagnostic) SLL 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
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 may be performed to identify a potential IGH::BCL3 fusion, t(14;19)(q32;q13).
In the absence of IGH::CCND1 fusion, when an extra or atypical CCND1 signal is identified, testing using the CCND1 break-apart probe set may be performed to identify a potential variant translocation involving CCND1, t(11;var)(q13;?).
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), 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 IGH::CCND1 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
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 set.
A positive result is not diagnostic for small lymphocytic lymphoma but may provide relevant prognostic information.
A negative result does not exclude the diagnosis an SLL clone or another 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 US Food and Drug Administration and 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 specimens will not be rejected.
Paraffin-embedded tissues that have been decalcified will be attempted but may not be successful for FISH analysis. The success rate of FISH studies on decalcified tissue is approximately 50%.
Fluorescent in situ hybridization studies will be attempted if sufficient tumor is present for analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing if insufficient tissue/tumor is available for testing.
If no FISH signals are observed post-hybridization, the case will be released indicating a lack of FISH results.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Swerdlow SH, Campo E, Harris NL eds. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC; 2017. WHO Classification of Tumours, Vol 2
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(1):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 probe sets. Rearrangements involving CCND1 are detected using a dual-color break-apart strategy probe set. 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.
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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 account representative. 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 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
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.
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
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| SLL | SLL, FISH, Tissue | 103621-9 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 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 |