Test Catalog

Test Id : PLASF

Plasma Cell Proliferative Disorder, FISH, Tissue

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

Supporting the diagnosis of plasmacytoma or myeloma when coordinated with a surgical pathology consultation

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
_I099 Interphases, 25-99 No, (Bill Only) No
_I300 Interphases, >=100 No, (Bill Only) No
_IL25 Interphases, <25 No, (Bill Only) No
_PADD Probe, +1 No, (Bill Only) No
_PB02 Probe, +2 No, (Bill Only) No
_PB03 Probe, +3 No, (Bill Only) No
_PBCT Probe, +2 No, (Bill Only) No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consult. If a pathology consult is requested, PATHC / Pathology Consultation should be ordered and the appropriate fluorescence in situ hybridization (FISH) test will be ordered and performed at an additional charge.

 

This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

 

A minimum of 35% plasma cell involvement is required for a successful paraffin plasma cell FISH evaluation. If a bone marrow clot specimen is submitted with less than 35% plasma cell involvement, the PLASF / Plasma Cell Proliferative Disorder, FISH, Tissue will be canceled.

 

For decalcified (bone) specimens, one FISH probe (break apart IGH) will be attempted. If this FISH probe is unsuccessful, testing will be canceled due to lack of hybridization as a result of the decalcification process. If the IGH FISH probe is successful, additional FISH probes will be evaluated as listed below.

 

The initial panel includes testing for the following abnormalities using the probes listed:

17p-, TP53/D17Z1

1q gain, TP73/1q22

14q32 rearrangement, IGH

 

Based on the results from the initial panel, reflex testing may be performed to identify the following abnormalities using the probes listed:

t(11;14)(q13;q32), CCND1/IGH

t(14;16)(q32;q23) IGH/MAF

t(4;14)(p16.3;q32) FGFR3/IGH

t(14;20)(q32;q12) IGH/MAFB 

 

This test is not designed for follow-up testing.

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

Fluorescence In Situ Hybridization (FISH)

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Plasma Cell Prolif, FISH, Ts

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

17p- (17p deletion) or TP53

IGH (14q32) rearrangement

Monoclonal Gammopathy of Unknown Significance (MGUS)

Multiple Myeloma

Plasma Cell Leukemia

t(4;14) - FGFR3/IGH

t(11;14) - CCND1/IGH

t(14;16) - IGH/MAF

t(14;20) - IGH/MAFB

+1q or 1q22

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consult. If a pathology consult is requested, PATHC / Pathology Consultation should be ordered and the appropriate fluorescence in situ hybridization (FISH) test will be ordered and performed at an additional charge.

 

This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

 

A minimum of 35% plasma cell involvement is required for a successful paraffin plasma cell FISH evaluation. If a bone marrow clot specimen is submitted with less than 35% plasma cell involvement, the PLASF / Plasma Cell Proliferative Disorder, FISH, Tissue will be canceled.

 

For decalcified (bone) specimens, one FISH probe (break apart IGH) will be attempted. If this FISH probe is unsuccessful, testing will be canceled due to lack of hybridization as a result of the decalcification process. If the IGH FISH probe is successful, additional FISH probes will be evaluated as listed below.

 

The initial panel includes testing for the following abnormalities using the probes listed:

17p-, TP53/D17Z1

1q gain, TP73/1q22

14q32 rearrangement, IGH

 

Based on the results from the initial panel, reflex testing may be performed to identify the following abnormalities using the probes listed:

t(11;14)(q13;q32), CCND1/IGH

t(14;16)(q32;q23) IGH/MAF

t(4;14)(p16.3;q32) FGFR3/IGH

t(14;20)(q32;q12) IGH/MAFB 

 

This test is not designed for follow-up testing.

Specimen Type
Describes the specimen type validated for testing

Tissue

Ordering Guidance

-For the most complete genetic evaluation on fresh bone marrow specimens, order MPCDS / mSMART, Plasma Cell Proliferative Disorder, FISH, Bone Marrow.

-For evaluation of high-risk abnormalities plus CCND1/IGH fusion on fresh bone marrow specimens, order PCPDS / Plasma Cell Proliferative Disorder, High Risk with Reflex Probes, Diagnostic FISH Evaluation, Bone Marrow.

-For fixed cell pellet specimens, order MFCDF / Myeloma, High Risk with Reflex Probes, Diagnostic FISH Evaluation, Fixed Cell Pellet

-Testing will be changed to the appropriate test if this test is ordered on either of the previous specimen types.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

A reason for testing and pathology report are required for testing to be performed. Send information with specimen. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
CG753 Reason for Referral

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Specimen Type: Tissue

Preferred: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

 

Acceptable: Slides

Collection Instructions: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

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

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Tissue Ambient (preferred)
Refrigerated

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

Supporting the diagnosis of plasmacytoma or myeloma when coordinated with a surgical pathology consultation

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consult. If a pathology consult is requested, PATHC / Pathology Consultation should be ordered and the appropriate fluorescence in situ hybridization (FISH) test will be ordered and performed at an additional charge.

 

This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

 

A minimum of 35% plasma cell involvement is required for a successful paraffin plasma cell FISH evaluation. If a bone marrow clot specimen is submitted with less than 35% plasma cell involvement, the PLASF / Plasma Cell Proliferative Disorder, FISH, Tissue will be canceled.

 

For decalcified (bone) specimens, one FISH probe (break apart IGH) will be attempted. If this FISH probe is unsuccessful, testing will be canceled due to lack of hybridization as a result of the decalcification process. If the IGH FISH probe is successful, additional FISH probes will be evaluated as listed below.

 

The initial panel includes testing for the following abnormalities using the probes listed:

17p-, TP53/D17Z1

1q gain, TP73/1q22

14q32 rearrangement, IGH

 

Based on the results from the initial panel, reflex testing may be performed to identify the following abnormalities using the probes listed:

t(11;14)(q13;q32), CCND1/IGH

t(14;16)(q32;q23) IGH/MAF

t(4;14)(p16.3;q32) FGFR3/IGH

t(14;20)(q32;q12) IGH/MAFB 

 

This test is not designed for follow-up testing.

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

A plasmacytoma is a localized proliferation of plasma cells that are cytologically and immunophenotypically identical to the plasma cell clones seen in myeloma. There are 2 primary types of plasmacytomas, solitary plasmacytoma of bone (SPB) and extramedullary plasmacytoma (EP).

 

SPBs are a localized bone tumor comprised of plasma cells and account for about 5% of all plasma cell neoplasms. Common sites for SPBs are the vertebrae, ribs, skull, pelvis, femur, clavicle, and scapula. Patients often present with pathological fracture or bone pain near the lesion. Treatment is typically radiation therapy; at 10 years, 35% of patients appear to be cured, 55% develop myeloma, and 10% have local recurrence.

 

EPs are tumors of plasma cells that form in areas away from the bone and account for 3% to 5% of all plasma cell neoplasms. Approximately 80% of EPs occur in the upper respiratory tract. Less common locations include the gastrointestinal tract, bladder, testis, central nervous system, and skin. Treatment consists of radiation therapy. Regional recurrence develops in about 25% of patients, but development of myeloma is less frequent, occurring in only about 15% of patients.

 

Genetics of both types of plasmacytomas, while not extensively studied, appear to be the same as plasma cell myeloma.

 

Paraffin plasma cell fluorescence in situ hybridization (FISH) evaluation of bone marrow clot specimens is also important when a fresh bone marrow specimen is not available or is unsuccessful in the initial/diagnostic evaluation to document the genetic abnormalities associated with a patient's plasma cell clone.

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 a given probe set.

 

A positive result supports the diagnosis of a plasmacytoma or myeloma.

 

A negative result does not exclude the diagnosis of a plasmacytoma or myeloma.

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 US Food and Drug Administration and is best used as an adjunct to existing clinical and pathologic information.

 

Fixatives other than formalin (eg, Prefer, Bouin) may not be successful for fluorescence in situ hybridization (FISH) assays. Although FISH testing will not be rejected due to non-formalin fixation, results may be compromised.

 

Paraffin-embedded tissues that have been decalcified may be unsuccessful for FISH analysis. FISH studies will usually be attempted. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.

Supportive Data

Each probe was independently tested and verified on paraffin-embedded tissue specimens. Normal cutoffs were calculated based on the results of at least 25 normal specimens. For each probe set a series of chromosomally abnormal specimens were evaluated to confirm each probe set detected the anomaly it was designed to detect.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Campo E, Harris NL, Jaffe ES, Pileri SA, Thiele J, eds: WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC Press; 2017

2. Nolan KD, Mone MC, Nelson EW: Plasma cell neoplasms: review of disease progression and report of a new variant. Surg Oncol. 2005 Aug;14(2):85-90

3. Dingli D, Kyle RA, Rajkumar SV, et al: Immunoglobulin free light chains and solitary plasmacytoma of bone. Blood. 2006;108(6):1979-1983

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

This test is performed using both commercially available and laboratory-developed probes. Deletion or monosomy of chromosome 17 and copy number gain of 1q are detected using enumeration strategy probes. Translocations involving IGH with FGFR3, CCND1, MAF, and MAFB are detected using dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probes. Rearrangement of IGH is detected using a break-apart strategy (BAP) probe. Formalin-fixed, paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin (H and E)-stained slide are performed by a pathologist. Using the H and E-stained slide as a reference, target areas are etched with a diamond-tipped etcher on the back of the unstained slide to be assayed. Each probe set is hybridized to the appropriate target areas and 2 technologists analyze 50 interphase nuclei each (100 total) with the results expressed as the percent abnormal nuclei.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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

Monday through Friday

Specimens are processed Monday through Sunday.

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 10 days

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

Slides and H and E used for analysis are retained by the laboratory in accordance to with CAP and NYS requirements. Client provided paraffin blocks and extra unstained slides (if provided) will be returned after testing is complete

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

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) 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 US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88271x2, 88291-DNA probe, each (first probe set), Interpretation and report

88271x2-DNA probe, each; each additional probe set (if appropriate)

88271x1-DNA probe, each; coverage for sets containing 3 probes (if appropriate)

88271x2-DNA probe, each; coverage for sets containing 4 probes (if appropriate)

88271x3-DNA probe, each; coverage for sets containing 5 probes (if appropriate)

88274 w/modifier 52-Interphase in situ hybridization, <25 cells, each probe set (if appropriate)

88274-Interphase in situ hybridization, 25 to 99 cells, each probe set (if appropriate)

88275-Interphase in situ hybridization, 100 to 300 cells, each probe set (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PLASF Plasma Cell Prolif, FISH, Ts In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
52219 Result Summary 50397-9
52221 Interpretation 69965-2
52220 Result Table 93356-4
54593 Result 62356-1
CG753 Reason for Referral 42349-1
52222 Specimen 31208-2
52223 Source 31208-2
52224 Tissue ID 80398-1
52225 Method 85069-3
55033 Additional Information 48767-8
52226 Released By 18771-6
53823 Disclaimer 62364-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports