Immunofixation, Daratumumab-Specific, Serum-994

Test info

  
Immunofixation, Daratumumab-Specific, Serum
  
994
  
LAB994
  
MSO
  
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
Dara
  
The in-vitro removal of potential IgG Κ M-protein interference to the serum IFE assay due to the DARA® drug administration
Quantitation of immunoglobulins IgA, IgG, and IgM; IFE interpretation of heavy- and light-chain patterns in the serum.
  

Detects and identifies monoclonal immunoglobulin gammopathies in the presence of therapeutic monoclonal antibody (mAbs) drug treatment with Daratumumab (Dara®), a human IgGκ 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.

Specimen

  

Overnight fasting is preferred, but not required.

  
Serum
  
  
2 mL
  
1 mL
  

Immediatley following collection, mix sample by inverting 5 times

  
  1. Allow sample to clot
  2. Spin
  
  

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.
  
  

Ambient (preferred) - 14 days

Refrigerated – 14 days

Frozen - 14 days

  

Plasma sample 

Performance

  
LabCorp (123218): R-LC
  
Tue, Thu
  
4 - 8 days
  

Electrophoresis followed by immunodiffusion against mono-specific antisera to immunoglobulin and individual heavy and light chains (IFE); turbidimetric quantitation of IgA, IgG, IgM.

Clinical and Interpretive info

  

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 proteinon 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.

Billing

  
82784 x 3
86334

Tracking

  
12/12/2022
  
05/17/2023
  
05/30/2023