Immunofixation, Daratumumab-Specific, Serum

CPT: 82784(x3); 86334
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Test Details


  • 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

Test Includes

The in-vitro removal of potential IgG Κ M-protein interference to the serum IFE assay due to the DARA® drug administration; Quantitation of immunoglobuilns IgA, IgG, and IgM; IFE interpretation of heavy- and light-chain patterns in the serum.


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.


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.

Reference Interval

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.

Specimen Requirements




2 mL

Minimum Volume

1 mL


Red-top tube or gel-barrier tube

Patient Preparation

Patient should be fasting.


Separate serum from red cells.

Storage Instructions

Room temperature

Stability Requirements



Room temperature

14 days


14 days


14 days

Freeze/thaw cycles

Stable x3

Causes for Rejection

Plasma sample

Clinical Information

Special Instructions

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


1. Murata K, McCash SI, Carroll B, et al. Treatment of multiple myeloma with monoclonal antibodies and the dilemma of false positive M-spikes in peripheral blood. Clin Biochem. Epub 2016 Sep 21.27664535
2. Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009 Jan;23(1):3-9.18971951
3. McCudden C, Axel AE, Slaets D, et al. Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference. Clin Chem Lab Med. 2016 Jun 1;54(6):1095-1104.27028734
4. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346.27511158


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
123218 IFE, Dara-Specific, Serum 001776 Immunoglobulin G, Qn, Serum mg/dL 2465-3
123218 IFE, Dara-Specific, Serum 001784 Immunoglobulin A, Qn, Serum mg/dL 2458-8
123218 IFE, Dara-Specific, Serum 001792 Immunoglobulin M, Qn, Serum mg/dL 2472-9
123218 IFE, Dara-Specific, Serum 123219 IFE, Serum 14895-7

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