Test Catalog

Test Id : CLLDF

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Chronic Lymphocytic Leukemia, Diagnostic FISH, Varies

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Overview

Test Catalog

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 chronic lymphocytic leukemia (CLL)

 

Identifying and tracking known chromosome abnormalities in patients with CLL and tracking response to therapy

 

Distinguishing patients with 11;14 translocations who have leukemic phase of mantle cell lymphoma from patients who have CLL

 

Detecting patients with atypical CLL or other forms of lymphoma associated 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
CLLDB Probe, Each Additional (CLLDF) 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 6 probe sets (12 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

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 additional IGH signal is identified in the absence of a CCND1/IGH fusion, reflex testing using the IGH/BCL3 probe set will be performed to identify a potential IGH/BCL3 fusion [t(14;19)(q32;q13)].

 

This assay detects abnormalities observed in the blood and bone marrow of patients with chronic lymphocytic leukemia. If a paraffin-embedded tissue sample is received, this test will be cancelled and SLL / Small Lymphocytic Lymphoma, FISH, Tissue will be added and performed as the appropriate test.

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

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

CLL, Diagnostic FISH

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

+12

11q- (11q deletion) or ATM

13q- (13q deletion) or LAMP1

17p- (17p deletion) or TP53

6q- (6q deletion) or MYB

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

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 6 probe sets (12 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

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 additional IGH signal is identified in the absence of a CCND1/IGH fusion, reflex testing using the IGH/BCL3 probe set will be performed to identify a potential IGH/BCL3 fusion [t(14;19)(q32;q13)].

 

This assay detects abnormalities observed in the blood and bone marrow of patients with chronic lymphocytic leukemia. If a paraffin-embedded tissue sample is received, this test will be cancelled and SLL / Small Lymphocytic Lymphoma, FISH, Tissue will be added and performed as the appropriate test.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

If testing a paraffin-embedded tissue specimen for patients with chronic lymphocytic leukemia (CLL) is desired, order SLL / Small Lymphocytic Lymphoma, FISH, Tissue.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

1. Provide a reason for testing with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed.

2. A pathology and/or flow cytometry report may be requested by the Genomics Laboratory to optimize testing and aid in interpretation of results.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
GC088 Reason for Referral
GC089 Specimen Whole Blood ACD
Bone Marrow ACD
Whole Blood Na Hep
Bone Marrow Na Hep
Whole Blood EDTA
Bone Marrow EDTA

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: Blood

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (sodium heparin), purple top (EDTA)

Specimen Volume: 6 mL

Collection Instructions: Invert several times to mix blood.

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (sodium heparin), purple top (EDTA)

Specimen Volume: 1-2 mL

Collection Instructions: Invert several times to mix bone marrow.

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

Blood: 2 mL

Bone Marrow: 1 mL

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
Varies 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 chronic lymphocytic leukemia (CLL)

 

Identifying and tracking known chromosome abnormalities in patients with CLL and tracking response to therapy

 

Distinguishing patients with 11;14 translocations who have leukemic phase of mantle cell lymphoma from patients who have CLL

 

Detecting patients with atypical CLL or other forms of lymphoma associated 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 6 probe sets (12 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

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 additional IGH signal is identified in the absence of a CCND1/IGH fusion, reflex testing using the IGH/BCL3 probe set will be performed to identify a potential IGH/BCL3 fusion [t(14;19)(q32;q13)].

 

This assay detects abnormalities observed in the blood and bone marrow of patients with chronic lymphocytic leukemia. If a paraffin-embedded tissue sample is received, this test will be cancelled and SLL / Small Lymphocytic Lymphoma, FISH, Tissue will be added and performed as the appropriate test.

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

Chronic lymphocytic leukemia (CLL) is the most common leukemia in North America. The most common 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 referral is a B-cell disorder (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 in 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
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.

 

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.

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. For each probe set a series of chromosomally abnormal specimens were evaluated to confirm each probe set detected the abnormality it was designed to detect.

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

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 Dec;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 Apr;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 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. Two technologists analyze each probe set and 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

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.

Monday through Friday

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

4 weeks

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.

88271 x 12

88275 x 6

88291 - FISH Probe, Analysis, Interpretation; 6 probe sets

88271 x 2 (if appropriate)

88275 x1 - FISH Probe, Analysis; each additional probe set (if appropriate)

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
CLLDF CLL, Diagnostic FISH In Process
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.
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 85298-8
610719 Method 85069-3
610720 Additional Information 48767-8
610721 Disclaimer 62364-5
610722 Released by 18771-6

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

Test Update Resources

Change Type Effective Date
Test Status - Test Resumed 2022-07-21
Test Status - Test Down 2021-06-25