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Test ID CLLDF Chronic Lymphocytic Leukemia, Diagnostic FISH, 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.



Specimen Required


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.


Useful For

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

Test ID Reporting Name Available Separately Always Performed
CLLDB Probe, Each Additional (CLLDF) No, (Bill Only) No

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 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.

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 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

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 Code Information

Test ID Test Order Name Order LOINC Value
CLLDF CLL, Diagnostic FISH In Process

 

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 85298-8
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.