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Test Code IFXED Immunofixation Heavy Chain Type Delta and Epsilon, Serum


Specimen Required


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.


Useful For

Identification and isotyping of IgD or IgE monoclonal gammopathy

 

Documentation of complete response to therapy with established monoclonal gammopathy consisting of an IgD or IgE heavy chain

Method Name

Immunofixation

Reporting Name

Immunofixation Delta and Epsilon, S

Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  14 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Monoclonal gammopathies indicate a clonal expansion of plasma cells or mature B lymphocytes that commonly consist of IgG, IgA, and IgM heavy chains. However, these monoclonal proteins may rarely consist of IgD or IgE immunoglobulin heavy chains. Diseases that are associated with monoclonal gammopathies include multiple myeloma, primary systemic amyloidosis, and light-chain deposition disease, as well as premalignant disorders such as smoldering multiple myeloma and monoclonal gammopathy of undetermined significance.

 

Initial Isotyping or immunofixation identifies the monoclonal immunoglobulin heavy-chain (gamma, alpha, or mu) and/or light-chain type (kappa or lambda). Since IgD and IgE monoclonal gammopathies are rare, they are not part of the initial screening/isotyping.

 

Since the anti-sera against IgD and IgE are excluded from initial screening methods, this testing should only be ordered on patients with confirmed IgD or IgE monoclonal gammopathy or patients with only free monoclonal kappa or lambda light chains upon initial isotyping. Once the presence of an IgD or IgE heavy chain is excluded, there is no need to continue monitoring with this specialized isotyping assay; rather, continued monitoring via serum protein electrophoresis and traditional isotyping is more appropriate.

Reference Values

Immunofixation Delta and Epsilon: No monoclonal IgD or IgE protein detected.

Immunofixation Delta and Epsilon, Flag: Negative

Interpretation

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

Cautions

Immunofixation for only IgD and IgE will not provide information about the more common heavy chains associated with monoclonal gammopathies (IgG, IgA, or IgM). Order PEISO / Protein Electrophoresis and Isotype, Serum or MPSS / Monoclonal Protein Study, Serum to obtain this information.

 

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

Method Description

Immunofixation is performed with reagents specific for delta and epsilon immunoglobulin heavy chains and kappa and lambda light chains. Immunofixation electrophoresis is performed in four stages: 1) separation of proteins by electrophoresis on an agarose gel; 2) immunofixation (immunoprecipitation) and fixation of the electrophoresed proteins;3) removal of unprecipitated soluble proteins by blotting and washing; and 4) staining of the precipitated proteins for visualization.(Package insert: HYDRAGEL 1, 2, 4 and 9 IF kit. Sebia Inc; 07/2020)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. 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

86334

LOINC Code Information

Test ID Test Order Name Order LOINC Value
IFXED Immunofixation Delta and Epsilon, S 104672-1

 

Result ID Test Result Name Result LOINC Value
606458 Immunofixation D and E 74665-1
606981 Flag, Immunofixation D and E No LOINC Needed

Day(s) Performed

Monday through Friday

Report Available

2 to 7 days