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, SSpecimen Type
SerumSpecimen 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 RochesterTest 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