Immunofixation Reflex, Serum
Test ID:
705138
CPT code:
82784 (x3), 86334
Synonyms:
Immunofixation, Daratumumab-Specific, Serum
Daratumumab Immunofixation Reflex Assay (DIRA)
Darzalex®
Electrophoresis, Serum, IFE
HYDRASHIFT 2/4 daratumumab
IEP, Serum
IFE, Serum
Immunoelectrophoresis, Serum
Immunofixation
Serum IEP
Serum Immunoelectrophoresis
Serum Immunofixation
Clinical 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
Test Information:
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 protein on Hydragel IF assay and therefore suggest a potential complete response (CR) or stringent complete response (sCR) if the Immunofixation with HYDRASHIFT 2/4 daratumumab confirms undetectable endogenous M proteins.
Specimen Type:
Serum
Requested Volume:
2 mL
Minimum Volume:
1 mL
Container Type:
Red-top tube or gel-barrier tube
Patient Preparation:
Patient should be fasting.
Collection:
Separate serum from red cells.
Storage Instructions:
Room temperature
Stability Requirements:
Temperature |
Period |
---|---|
Room temperature |
14 days |
Refrigerated |
14 days |
Frozen |
14 days |
Freeze/thaw cycles |
Stable x3 |
Rejection Criteria
Plasma sample
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