Test Catalog

Test Id : IMFXO

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Immunofixation Only, Serum

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Overview

Test Catalog

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.

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

Identification of monoclonal immunoglobulin heavy and light chains

 

Documentation of complete response to therapy

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
IFXED Immunofixation Delta and Epsilon, S Yes No

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

If a monoclonal light-chain is detected in the absence of an associated monoclonal heavy-chain, immunofixation electrophoresis specific for delta and epsilon chains is performed, if not previously performed, or at the discretion of the laboratory director reviewing the case.

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

Immunofixation

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

No

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

Immunofixation Only, S

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

IEP (Immunoelectrophoresis)

Heavy Chains

IEP

IFE/s

Immunoelectrophoresis, Serum

Immunofix by subtract

Immunofixation, Serum

Immunosubtraction, Serum

Kappa Chains, Serum

Light Chains, Serum

Macroglobulins

Monoclonal Protein Study

Myeloma Studies

Protein Analysis, Myeloma

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.

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

If a monoclonal light-chain is detected in the absence of an associated monoclonal heavy-chain, immunofixation electrophoresis specific for delta and epsilon chains is performed, if not previously performed, or at the discretion of the laboratory director reviewing the case.

Specimen Type
Describes the specimen type validated for testing

Serum

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

Patient Preparation: Fasting preferred but not required

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

See Specimen Required

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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
Serum Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 14 days

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.

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

Identification of monoclonal immunoglobulin heavy and light chains

 

Documentation of complete response to therapy

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

If a monoclonal light-chain is detected in the absence of an associated monoclonal heavy-chain, immunofixation electrophoresis specific for delta and epsilon chains is performed, if not previously performed, or at the discretion of the laboratory director reviewing the case.

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

Monoclonal gammopathies indicate a clonal expansion of plasma cells or mature B lymphocytes. The monoclonal gammopathies include diseases such as multiple myeloma, Waldenstrom macroglobulinemia, lymphoproliferative disease, primary systemic amyloidosis, light-chain deposition disease, as well as the premalignant disorders of smoldering myeloma and monoclonal gammopathy of undetermined significance (MGUS). Monoclonal gammopathy patients may have a relatively small monoclonal protein abnormality or a large quantifiable peak (M-spike) on serum or urine protein electrophoresis. Abnormalities detected on serum protein electrophoresis (SPE) should have immunotyping performed to confirm and characterize the monoclonal protein. Immunotyping of monoclonal proteins is usually done by immunofixation electrophoresis (IFE) and identifies the monoclonal immunoglobulin heavy-chain (gamma, alpha, mu, delta, or epsilon) and/or light-chain type (kappa or lambda). It is generally recommended that both SPE and IFE be used as a screening panel. Because IFE is more sensitive than SPE, IFE is not only recommended as part of the initial screening process but also for confirmation of complete response to therapy.

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.

Immunofixation: No monoclonal protein detected

Immunofixation Flag: Negative

Interpretation
Provides information to assist in interpretation of the test results

Immunofixation electrophoresis (IFE) is primarily performed to identify and characterize the presence of any monoclonal immunoglobulin heavy and/or light chains. 

 

Immunofixation impression comments are made based on visual interpretation of gels.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Immunofixation is not a quantitative assay. If a monoclonal protein is identified, a serum protein electrophoresis assay is required for quantifying the abnormality.

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

1. Keren DF, Humphrey RL: Clinical indications and applications of serum and urine protein electrophoresis. In: Detrick B, Schmitz JL, Hamilton RG, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:74-88

2. Katzmann JA, Keren DF: Strategy for detecting and following monoclonal gammopathies. In: Detrick B, Schmitz JL, Hamilton RG, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:112-124

3. Kyle RA, Katzmann JA, Lust, JA, Dispenzieri A: Clinical indications and applications of electrophoresis and immunofixation. In:  Rose NR, Hamilton RG, Detrick B, eds. Manual of Clinical Laboratory Immunology. 6th ed. ASM Press; 2002:66-70

4. Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.

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

Immunofixation is performed with Sebia reagent sets and are specific for gamma, alpha, and mu immunoglobulin heavy-chains, and kappa, and lambda light-chains.(Package insert: Sebia Hydrasys Hydragel 1, 2, 4, and 9IF. Sebia, Inc; 09/2015)

 

Immunofixation electrophoresis is a 2-stage procedure using agarose gel high resolution electrophoresis in the first stage and immunoprecipitation in the second to detect monoclonal gammopathy.(Package insert: SPIFE ImmunoFix Procedure. Helena Laboratories; 08/2012)

 

If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, immunofixation electrophoresis (IFE) specific for delta and epsilon chains is performed.(Sykes E, Posey Y: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Schmitz JL, Hamilton RG, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:89-100)

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

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.

2 to 7 days

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

14 days

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

Jacksonville

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.

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 account representative. 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

86334

86334-Immunofixation Delta and Epsilon (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
IMFXO Immunofixation Only, S 74665-1
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.
32436 Immunofixation 74665-1
606978 Flag, Immunofixation No LOINC Needed

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.

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