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.

Gold serum separator (SST) tube

Immediatley following collection, mix sample by inverting 5 times

1. Allow sample to clot
2. Spin

Red serum vial/tube, 5 mL

Immediatley following collection, mix sample by inverting 5 times

1. Allow sample to clot
2. Spin
3. Transfer serum to a Transfer vial/tube with cap - 12mL (LabCorp) labeled as serum.

Transfer vial/tube with cap - 12mL (LabCorp)

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.