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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