Sign in →

Immunofixation, Daratumumab-Specific, Serum

Important Note

Cerner Order Name: Send Out:Other

LabCorp Test ID 123218

Note: Only for patients undergoing therapeutic monoclonal antibody (mAbs) drug treatment with Daratumumab (Dara®)

State patient's age and clinical diagnosis on the test request form.

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.

Custom 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.

Icon & Photos

Gold Top (SST-Gel)

Specimen Requirements

Preferred:
Container/Tube: Gold Top (SST-Gel)
Minimum Volume: 2 mL
Collection Instructions: Separate serum from red cells.
Also Acceptable:
Container/Tube: Other SST Gel, Red Top Tube

Specimen Stability

Temperature Period
Room temperature 14 days
Refrigerated 14 days
Frozen 14 days

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.

CPT

82784 (x3)

86334

Test Alias

IFE
IEP
Immunoelectrophoresis, Serum

Report Available

4-8 days