Immunofixation, Daratumumab-Specific, Serum
Also known as: Daratumumab Immunofixation Reflex Assay (DIRA), Darzalex®, Electrophoresis, Serum, IFE, HYDRASHIFT 2/4 daratumumab, IEP, Serum
Use
Detect and identify monoclonal immunoglobulin gammopathies in the presence of therapeutic monoclonal antibody (mAbs) drug treatment with Daratumumab (Dara®), a human IgG1 κ mAb, which migrates in the electrophoretic γ globulin zone of the electrophoresis gel. In this laboratory procedure, the Dara® in vitro interference is removed using an anti-daratumumab antibody reagent. This procedure will characterize the specific light and heavy chain components of a monoclonal protein without Dara® interference.
Special Instructions
Not provided.
Limitations
The test may face limitations in patients with complex immunological backgrounds or those undergoing multiple monoclonal antibody therapies, as different therapeutic reagents may interfere with accurate detection of endogenous M proteins. Additional time for confirmatory or reflex tests may be necessary depending on the patient's clinical conditions and treatment history.
Methodology
Immunoassay (Other)
Biomarkers
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
6-8 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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