Test ID: FMFC
Myeloma, FISH, Fixed Cells
Secondary ID
A test code used for billing and in test definitions created prior to November 2011
NY State Approved
Indicates the status of NY State approval and if the test is orderable for NY State clients.
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 ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| ADD1F | One Additional FISH Probe | No | No |
| ADD2F | Two Additional FISH Probes | No | No |
| ADD4F | Four Additional FISH Probes | No | No |
| ADD3F | Three Additional FISH Probes | No | No |
| ADD5F | Five Additional FISH Probes | No | No |
| ADD6F | Six Additional FISH Probes | No | No |
| ADD7F | Seven Additional FISH Probes | No | No |
| ADD8F | Eight Additional FISH Probes | No | No |
| ADD9F | Nine Additional FISH Probes | No | No |
| ADD10 | Ten Additional FISH Probes | No | No |
| ADD11 | Eleven Additional FISH Probes | No | No |
| ADD12 | Twelve Additional FISH Probes | No | No |
| 14FP | Fourteen Additional FISH Probes | No | No |
| 13FP | Thirteen Additional FISH Probes | No | No |
| 15FP | Fifteen Additional FISH Probes | No | No |
| 16FP | Sixteen Additional FISH Probes | No | No |
| 17FP | Seventeen Additional FISH Probes | No | No |
| 18FP | Eighteen Additional FISH Probes | No | No |
| 19FP | Nineteen Additional FISH Probes | No | No |
| 20FP | Twenty Additional FISH Probes | No | No |
| 21FP | Twenty One Additional FISH Probes | No | No |
| 22FP | Twenty Two Additional FISH Probes | No | No |
| 23FP | Twenty Three Additional FISH Probes | No | No |
| 24FP | Twenty Four Additional FISH Probes | No | No |
| 25FP | Twenty Five Additional FISH Probes | No | No |
| 26FP | Twenty Six Additional FISH Probes | No | No |
| 27FP | Twenty Seven Additional FISH Probes | No | No |
| 28FP | Twenty Eight Additional FISH Probes | No | No |
| 29FP | Twenty Nine Additional FISH Probes | No | No |
| 30FP | Thirty Additional FISH Probes | No | No |
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
Aliases
Lists additional common names for a test, as an aid in searching
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
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 Type | Temperature | Time |
|---|---|---|
| Fixed Cell Pellet Bone Marrow | Ambient (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.
Maximum Laboratory Time
Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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
The location of the laboratory that performs the test
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.
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 ID | Reporting Name | LOINC Code |
|---|---|---|
| 51013 | Specimen | 31208-2 |
| 51014 | Specimen ID | N/A |
| 51015 | Source | N/A |
| 51016 | Order Date | N/A |
| CG408 | Reason For Referral | 42349-1 |
| 51018 | Method | In Process |
| 51019 | Result | In Process |
| 51020 | Interpretation | 69965-2 |
| 51021 | Amendment | In Process |
| 51022 | Reviewed By | N/A |
| 51023 | Release Date | N/A |


