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Test Code CLLDF Chronic Lymphocytic Leukemia, Diagnostic FISH, Varies


Ordering Guidance


This test is intended for instances when the entire chronic lymphocytic leukemia (CLL) fluorescence in situ hybridization (FISH) panel is needed.

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 are requested 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.


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

Testing Algorithm

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 [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

This test is performed as panel testing only and will be performed using the following analysis algorithm. Modifications of the FISH probes or chronic lymphocytic leukemia (CLL) algorithm are not allowed for this test.

 

The 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

 

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.

 

In the absence of CCND1::IGH fusion, when an extra IGH signal is identified, additional testing using the IGH/BCL3 probe set will be considered at the laboratory's discretion to identify a potential IGH::BCL3 fusion [t(14;19)(q32;q13)]. Laboratory discretion may be influenced by available karyotype results and previous CLL FISH testing.

Reporting Name

CLL, Diagnostic 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 

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

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

88271x12, 88275x6, 88291-FISH Probe, Analysis, Interpretation; 6 probe sets

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CLLDF CLL, Diagnostic FISH 101788-8

 

Result ID Test Result Name Result LOINC Value
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 31208-2
610719 Method 85069-3
610720 Additional Information 48767-8
610721 Disclaimer 62364-5
610722 Released by 18771-6

Forms

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