Test ID: FPCPD
Plasma Cell Proliferative Disorder (PCPD), FISH
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 or other plasma cell proliferative disorders
Identifying prognostic markers based on the anomalies found
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
This test is designed for diagnostic specimens. The test panel includes analysis for the disease-associated abnormalities using the probes listed below.
-13/13q-, RB1/LAMP1
t(11;14), CCND1/IGH
t(14;var), IGH
17p-, TP53/Cen17
+3/+7, Cen3/Cen7
+9/+15, Cen9/Cen15
t(4;14) IGH reflex, FGFR3/IGH
t(14;16) IGH reflex, IGH/MAF
t(14;20) IGH reflex, IGH/MAFB
t(6;14) IGH reflex, CCND3/IGH
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) Followed by Cytoplasmic Immunoglobulin (cIg) Staining
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
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
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.
Container/Tube: Green top (sodium heparin)
Specimen Volume: 1-2 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Other anticoagulants are not recommended and are harmful to the viability of the cells.
3. Advise Express Mail or equivalent if not on courier service.
Additional Information: Blood is acceptable.
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.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Clotted bone marrow |
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 |
|---|---|---|
| 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 plasma cell proliferative disorders (PCPDs): 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.
This test should not be used to track the progression of disease.
Supportive Data
A total of 101 specimens were analyzed using the cytoplasmic immunoglobulin (cIg) fluorescence in situ hybridization (FISH) method. Of these 81 had reasons for referral of any plasma cell proliferative disorders (PCPD), 20 had reasons for referral not related to PCPD and served as negative controls. The 20 normal value specimens were found to be normal by the cIg method. Of the 81 PCPD 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. Testing with other methodologies on these 45 specimens identified only 26 specimens (58%) as abnormal by non-cIg FISH analysis and only 10 specimens (22%) as abnormal by conventional chromosome analysis. In addition, 37 specimens were analyzed for chromosomal aneusomy and 24 (65%) were hyperdiploid for at least 1 of the 4 chromosomes tested.
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. Bone marrow samples are processed to keep the cytoplasm of the leukocytes intact. At least 2 slides with 2 hybridization sites each are prepared using a cytospin centrifuge. Each probe set is hybridized to a separate hybridization site. Plasma cells are specifically detected by using immunoglobulin staining techniques with commercially available antibodies (cIg) for kappa and lambda. 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. Translocation involving chromosome 14 (IGH) with chromosomes 4 (FGFR3), 11 (CCND1), or 16 (MAF) are detected by D-FISH strategies. For each probe set, 50 plasma cells (if possible) are scored and the result for each probe is reported. (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.
88240-Cryopreservation, freezing and storage of cells
88271 x 12-DNA probe, each
88275 x 2-Interphase in situ hybridization
88291-Interpretation and report
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 |
|---|---|---|
| 22613 | Specimen | 31208-2 |
| 22614 | Specimen ID | N/A |
| 22615 | Source | N/A |
| 22616 | Order Date | N/A |
| G_569 | Reason For Referral | 42349-1 |
| 22618 | Method | In Process |
| 22619 | Results | In Process |
| 22620 | Interpretation | 69965-2 |
| 22621 | Amendment | In Process |
| 22622 | Consultant | N/A |
| 22623 | Report Date | N/A |
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