Immunofixation, Isatuximab-Specific, Serum
Also known as: Electrophoresis, Serum, IFE, HYDRASHIFT 2/4 isatuximab, IEP, Serum, IFE, Serum, Immunoelectrophoresis, Serum
Use
Detect and identify monoclonal immunoglobulin gammopathies in the presence of therapeutic monoclonal antibody (mAbs) drug treatment with isatuximab (SARCLISA®), a human IgG1 kappa mAb, which migrates in the electrophoretic gamma globulin zone of the electrophoresis gel. In this laboratory procedure, the isatuximab in vitro interference is removed using an anti-isatuximab antibody reagent. This procedure will characterize the specific light and heavy chain components of a monoclonal protein without isatuximab interference.
Special Instructions
Not provided.
Limitations
Interference from therapeutic monoclonal antibodies such as isatuximab can affect the electrophoresis results, but the use of the HYDRASHIFT 2/4 isatuximab reagent helps mitigate this by facilitating the migration of isatuximab/anti-Isatuximab complexes. A complete response to therapy or strict complete response can be suggested by a negative immunofixation result along with clinical assessment.
Methodology
Immunoassay
Biomarkers
IgA
ProteinIgG
ProteinIgM
Protein
LOINC Codes
- 14895-7 - Prot Pattern SerPl IFE-Imp
- 2465-3 - IgG SerPl-mCnc
- 2458-8 - IgA SerPl-mCnc
- 2472-9 - IgM SerPl-mCnc
Result Turnaround Time
4-8 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2 mL
Minimum Volume
1 mL
Container
Red-top tube or gel-barrier tube
Collection Instructions
Separate serum from red cells.
Patient Preparation
Overnight fasting is preferred but not required.
Storage Instructions
Room temperature
Causes for Rejection
Plasma sample
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
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