Immunofixation, Daratumumab-Specific, Serum
Immunofixation, Daratumumab-Specific, Serum-994
Darzalex®
Electrophoresis, Serum, IFE
HYDRASHIFT 2/4 daratumumab
IEP, Serum
IFE, Serum
Immunoelectrophoresis, Serum
Immunofixation
Serum IEP
Serum Immunoelectrophoresis
Serum Immunofixation
Dara
Quantitation of immunoglobulins IgA, IgG, and IgM; IFE interpretation of heavy- and light-chain patterns in the serum.
Detects and identifies 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.
Overnight fasting is preferred, but not required.
Immediatley following collection, mix sample by inverting 5 times
- Allow sample to clot
- Spin
Immediatley following collection, mix sample by inverting 5 times
- Allow sample to clot
- Spin
- Transfer serum to a Transfer vial/tube with cap - 12mL (LabCorp) labeled as serum.
Ambient (preferred) - 14 days
Refrigerated – 14 days
Frozen - 14 days
Plasma sample
Electrophoresis followed by immunodiffusion against mono-specific antisera to immunoglobulin and individual heavy and light chains (IFE); turbidimetric quantitation of IgA, IgG, IgM.
Normal pattern
DARAZLEX® (daratumumab) is a human monoclonal IgG κ antibody targeting CD38 that has been shown to provide clinical benefit as monotherapy in heavily pre-treated multiple myeloma patients and when combined with standard of care regimens for the treatment of MM in patients with the earlier disease.
The HYDRASHIFT 2/4 daratumumab reagent allows the laboratory to distinguish daratumumab interference from endogenous M protein1 on Hydragel IF assay and therefore suggest a potential complete response (CR) or stringent complete response (sCR)2-4 if the Immunofixation with HYDRASHIFT 2/4 daratumumab confirms undetectable endogenous M proteins.
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