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Immunofixation, Daratumumab-Specific, Serum
- Daratumumab Immunofixation Reflex Assay (DIRA)
- Electrophoresis, Serum, IFE
- HYDRASHIFT 2/4 daratumumab
- IEP, Serum
- IFE, Serum
- Immunoelectrophoresis, Serum
- Serum IEP
- Serum Immunoelectrophoresis
- Serum Immunofixation
The in-vitro removal of potential IgG Κ M-protein interference to the serum IFE assay due to the DARA® drug administration; Quantitation of immunoglobuilns IgA, IgG, and IgM; IFE interpretation of heavy- and light-chain patterns in the serum.
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.
Electrophoresis followed by immunodiffusion against mono-specific antisera to immunoglobulin and individual heavy and light chains (IFE); turbidimetric quantitation of IgA, IgG, IgM.
The HYDRASHIFT 2/4 daratumumab gel shift assay uses an anti-daratumumab antibody to allow for the migration of Daratumumab/anti-daratumumab complexes away from the γ globulin zone on IFE, toward the α1-globulin fraction, thus removing IgG κ interference in the γ globulin zone caused by Daratumumab in the patient's serum.
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.
Separate serum from red cells.
Causes for Rejection
State patient's age and clinical diagnosis on the test request form.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|123218||IFE, Dara-Specific, Serum||123219||IFE, Serum||14895-7|
|123218||IFE, Dara-Specific, Serum||001776||Immunoglobulin G, Qn, Serum||mg/dL||2465-3|
|123218||IFE, Dara-Specific, Serum||001784||Immunoglobulin A, Qn, Serum||mg/dL||2458-8|
|123218||IFE, Dara-Specific, Serum||001792||Immunoglobulin M, Qn, Serum||mg/dL||2472-9|