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HelpTest Code LABMMDSI Multiple Myeloma, Daratumumab-Specific, Immunofixation
Additional Codes
| Test Name in EPIC | EPIC Test Code | Mnemonic | LabCorp Test Code |
|---|---|---|---|
| Multiple Myeloma, Daratumumab-Specific Immunofixation | LABMMDSI | 123218 DARA | 123218 |
Useful For/Utility
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.
Methodology
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.
Specimen Requirements
Overnight fasting is perferred, but not required.
Submit only 1 of the following specimens:
Specimen Type: Serum
Continue/Tube: Plain Red top; Serum SST acceptable
Specimen Volume: 2 mL
Specimen Minimum Volume: 1 mL
Specimen Transport Temperature
Red-top tube or gel-barrier tube
Ship Room Temp
Day(s) Test Set Up
TAT 4-8 days Testing schedules vary
Performing Laboratory
LabCorp Burlington
Test Classification and CPT Coding
CPT: 82784(x3); 86334
Reference Values
Normal pattern
Additional 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 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.