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Test ID: FMFC
Myeloma, FISH, Fixed Cells

Secondary ID A test code used for billing and in test definitions created prior to November 2011

60405

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

Yes

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

Aiding in the diagnosis of new cases of multiple myeloma

 

Identifying prognostic markers based on the anomalies found

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
ADD1FOne Additional FISH ProbeNoNo
ADD2FTwo Additional FISH ProbesNoNo
ADD4FFour Additional FISH ProbesNoNo
ADD3FThree Additional FISH ProbesNoNo
ADD5FFive Additional FISH ProbesNoNo
ADD6FSix Additional FISH ProbesNoNo
ADD7FSeven Additional FISH ProbesNoNo
ADD8FEight Additional FISH ProbesNoNo
ADD9FNine Additional FISH ProbesNoNo
ADD10Ten Additional FISH ProbesNoNo
ADD11Eleven Additional FISH ProbesNoNo
ADD12Twelve Additional FISH ProbesNoNo
14FPFourteen Additional FISH ProbesNoNo
13FPThirteen Additional FISH ProbesNoNo
15FPFifteen Additional FISH ProbesNoNo
16FPSixteen Additional FISH ProbesNoNo
17FPSeventeen Additional FISH ProbesNoNo
18FPEighteen Additional FISH ProbesNoNo
19FPNineteen Additional FISH ProbesNoNo
20FPTwenty Additional FISH ProbesNoNo
21FPTwenty One Additional FISH ProbesNoNo
22FPTwenty Two Additional FISH ProbesNoNo
23FPTwenty Three Additional FISH ProbesNoNo
24FPTwenty Four Additional FISH ProbesNoNo
25FPTwenty Five Additional FISH ProbesNoNo
26FPTwenty Six Additional FISH ProbesNoNo
27FPTwenty Seven Additional FISH ProbesNoNo
28FPTwenty Eight Additional FISH ProbesNoNo
29FPTwenty Nine Additional FISH ProbesNoNo
30FPThirty Additional FISH ProbesNoNo

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

The number of probes ordered will determine the price of the testing. When this test is ordered, a charge for 2 FISH probes and interpretation is included. If additional probes or the entire panel are ordered, additional probe charges will be added.

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

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

Fluorescence In Situ Hybridization (FISH)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Myeloma, FISH, Fixed Cells

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

CCND3/IGH
del(13q)
Deletion 13
Deletion 17p
FGFR3/IGH
FISH for Plasma Cell Disorder
IGH/c-MAF
IGH/MAFB
MGUS (Monoclonal Gammopathy of Unknown Significance)
Monoclonal Gammopathy of Unknown Significance (MGUS)
Monosomy 13
Multiple Myeloma
p53
PCPD (Plasma Cell Proliferative Disorder)
Plasma Cell Leukemia
Plasma Cell Proliferative Disorder (PCPD)
Rb1
t(11;14)
t(14;16), Diagnostic specimen only
t(14;20)
t(4;14), Diagnostic specimen only
t(6;14)
TP53
CCND1/IGH
MAF

Specimen Type Describes the specimen type needed for testing

Fixed Cell Pellet Bone Marrow

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Provide a reason for referral 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.

 

Provide a pathology report with each specimen.

 

Container/Tube: Sterile container

Specimen Volume: 1 fixed cell pellet

Collection Instructions: Place specimen in a sterile container with a 3:1 (or similar) fixative (methanol:glacial acetic acid).

Additional Information: Advise Express Mail or equivalent if not on courier service.

Forms:

1. Cytogenetics Hematologic FISH Panel Patient Information Sheet (Supply T603) in Special Instructions

2. If not ordering electronically, submit a Cytogenetics Hematologic Disorders Request Form (Supply T607) with the specimen.

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

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Fixed Cell Pellet Bone MarrowAmbient (preferred)
 Refrigerated 

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

Multiple myeloma is a hematologic neoplasm that generally originates in the bone marrow and develops from malignant plasma cells. There are 4 main categories of myeloma: asymptomatic myeloma, smoldering myeloma, indolent myeloma, and multiple myeloma. Asymptomatic myeloma patients have nonspecific symptoms that may be attributed to other diseases. Generalized bone pain, anemia, numbness or limb weakness, symptoms of hypercalcemia, and recurrent infections are all symptoms that may indicate myeloma. In smoldering myeloma there is a monoclonal protein spike, but it is stable. Indolent myeloma is a slowly progressing myeloma.

 

As myeloma progresses, the malignant plasma cells interfere with normal blood product formation in the bone marrow resulting in anemia and leukopenia. Myeloma also causes an overstimulation of osteoclasts, causing excessive breakdown of bone tissue without the normal corresponding bone formation. These bone lesions are seen in approximately 66% of myeloma patients. In advanced disease, bone loss may reach a degree where the patient suffers fractures easily.

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.

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 FDA and is best used as an adjunct to existing clinical and pathologic information.

Supportive Data

The establishment of normal cutoffs on fixed cell pellets was determined based on analysis of 25 normal bone marrow specimens. Validation of the probes was performed on 81 specimens referred with an indication of myeloma using the cytoplasmic immunoglobulin (cIg) FISH method. Of these 81 specimens, 45 had sufficient plasma cells for analysis (at least 25 plasma cells per hybridization site). Of 45 specimens, 44 (98%) specimens were found to be abnormal for the probe sets used.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Fonseca R, Blood E, Rue M, et al: Clinical and biologic implications of recurrent genomic aberrations in myeloma. Blood 2003 Jun 1;101(11):4569-4575

2. Fonseca R, Blood EA, Oken MM, et al: Myeloma and the t(11;14) (q13;q32); evidence for a biologically defined unique subset of patients. Blood 2002 May 15;99(10):3735-3741

3. Shaughnessy J, Tian E, Sawyer J, et al: High incidence of chromosome 13 deletion in multiple myeloma detected by multiprobe interphase FISH. Blood 2000 Aug 15;96(4):1505-1511

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

This test uses commercially available and laboratory-developed chromosome-specific fluorescent-labeled DNA probes for FISH testing. Deletions or monosomies of chromosomes 13 and 17 are detected using FISH enumeration strategies. Centromere probes are used to detect chromosomal aneusomies for chromosomes 3, 7, 9, and 15. Translocations involving chromosome 14 (IGH) with chromosomes 4 (FGFR3), 6 (CCND3), 11 (CCND1), 16 (MAF), or 20 (MAFB) are detected by D-FISH strategies. For the enumeration and BAP probe sets, 200 interphase nuclei are scored and for the D-FISH probe sets, 500 interphase nuclei are scored. Results for each abnormal probe set are expressed as percent abnormal nuclei. (Shaughnessy J, Tian E, Sawyer J, et al: High incidence of chromosome 13 deletion in multiple myeloma detected by multiprobe interphase FISH. Blood 2000 Aug 15;96[4]:1505-1511)

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

Samples processed Monday through Sunday. Results reported Monday through Friday, 8 a.m.-5 p.m. CST.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

10 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

10 days

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

Indefinitely

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

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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 U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

Myeloma, FISH, Fixed Cells

88271 x 2-DNA probe, each

88275 x 2-Interphase in situ hybridization

88291-Interpretation and report

 

One Additional FISH Probe

88271-DNA probe, each (if appropriate)

88275-Interphase in situ hybridization (if appropriate)

 

Two Additional FISH Probes

88271 x 2-DNA probe, each (if appropriate)

88275-Interphase in situ hybridization (if appropriate)

 

Three Additional FISH Probes

88271 x 3-DNA probe, each (if appropriate)

88275-Interphase in situ hybridization (if appropriate)

 

Four Additional FISH Probes

88271 x 4-DNA probe, each (if appropriate)

88275 x 2-Interphase in situ hybridization (if appropriate)

 

Five Additional FISH Probes

88271 x 5-DNA probe, each (if appropriate)

88275 x 2-Interphase in situ hybridization (if appropriate)

 

Six Additional FISH Probes

88271 x 6-DNA probe, each (if appropriate)

88275 x 3-Interphase in situ hybridization (if appropriate)

 

Seven Additional FISH Probes

88271 x 7-DNA probe, each (if appropriate)

88275 x 3-Interphase in situ hybridization (if appropriate)

 

Eight Additional FISH Probes

88271 x 8-DNA probe, each (if appropriate)

88275 x 4-Interphase in situ hybridization (if appropriate)

 

Nine Additional FISH Probes

88271 x 9-DNA probe, each (if appropriate)

88275 x 4-Interphase in situ hybridization (if appropriate)

 

Ten Additional FISH Probes

88271 x 10-DNA probe, each (if appropriate)

88275 x 5-Interphase in situ hybridization (if appropriate)

 

Eleven Additional FISH Probes

88271 x 11-DNA probe, each (if appropriate)

88275 x 5-Interphase in situ hybridization (if appropriate)

 

Twelve Additional FISH Probes

88271 x 12-DNA probe, each (if appropriate)

88275 x 6-Interphase in situ hybridization (if appropriate)

 

Thirteen Additional FISH Probes

88271 x 13-DNA probe, each (if appropriate)

88275 x 6-Interphase in situ hybridization (if appropriate)

 

Fourteen Additional FISH Probes

88271 x 14-DNA probe, each (if appropriate)

88275 x 7-Interphase in situ hybridization (if appropriate)

 

Fifteen Additional FISH Probes

88271 x 15-DNA probe, each (if appropriate)

88275 x 7-Interphase in situ hybridization (if appropriate)

 

Sixteen Additional FISH Probes

88271 x 16-DNA probe, each (if appropriate)

88275 x 8-Interphase in situ hybridization (if appropriate)

 

Seventeen Additional FISH Probes

88271 x 17-DNA probe, each (if appropriate)

88275 x 8-Interphase in situ hybridization (if appropriate)

 

Eighteen Additional FISH Probes

88271 x 18-DNA probe, each (if appropriate)

88275 x 9-Interphase in situ hybridization (if appropriate)

 

Nineteen Additional FISH Probes

88271 x 19-DNA probe, each (if appropriate)

88275 x 9-Interphase in situ hybridization (if appropriate)

 

Twenty Additional FISH Probes

88271 x 20-DNA probe, each (if appropriate)

88275 x 10-Interphase in situ hybridization (if appropriate)

 

 Twenty One Additional FISH Probes

88271 x21-DNA probe, each (if appropriate)

88275 x10-Interphase in situ hybridization (if appropriate)

 

Twenty Two Additional FISH Probes

88271 x22-DNA probe, each (if appropriate)

88275 x11-Interphase in situ hybridization (if appropriate)

 

Twenty Three Additional FISH Probes

88271 x23-DNA probe, each (if appropriate)

88275 x11-Interphase in situ hybridization (if appropriate)

 

Twenty Four Additional FISH Probes

88271 x24-DNA probe, each (if appropriate)

88275 x12-Interphase in situ hybridization (if appropriate)

 

Twenty Five Additional FISH Probes

88271 x25-DNA probe, each (if appropriate)

88275 x12-Interphase in situ hybridization (if appropriate)

 

Twenty Six Additional FISH Probes

88271 x26-DNA probe, each (if appropriate)

88275 x13-Interphase in situ hybridization (if appropriate)

 

Twenty Seven Additional FISH Probes

88271 x27-DNA probe, each (if appropriate)

88275 x13-Interphase in situ hybridization (if appropriate)

 

Twenty Eight Additional FISH Probes

88271 x28-DNA probe, each (if appropriate)

88275 x14-Interphase in situ hybridization (if appropriate)

 

Twenty Nine Additional FISH Probes

88271 x29-DNA probe, each (if appropriate)

88275 x14-Interphase in situ hybridization (if appropriate)

 

Thirty Additional FISH Probes

88271 x30-DNA probe, each (if appropriate)

88275 x15-Interphase in situ hybridization (if appropriate)

 

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
51013Specimen31208-2
51014Specimen IDN/A
51015SourceN/A
51016Order DateN/A
CG408Reason For Referral42349-1
51018MethodIn Process
51019ResultIn Process
51020Interpretation69965-2
51021AmendmentIn Process
51022Reviewed ByN/A
51023Release DateN/A