Immunofixation, Daratumumab-Specific, Serum

TEST: 123218
Test number copied
CPT: 82784(x3); 86334
Print Share

Synonyms

  • 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.

Special Instructions

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

Expected Turnaround Time

4 - 8 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

For more information, please view the literature below.

Published Plasma Cell Dyscrasias Selection Table

Specimen Requirements

Specimen

Serum

Volume

2 mL

Minimum Volume

1 mL

Container

Red-top tube or gel-barrier tube

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

Patient Preparation

Overnight fasting is preferred, but not required.

Causes for Rejection

Plasma sample

Test Details

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.

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.

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.

Footnotes

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
123218 IFE, Dara-Specific, Serum 123219 IFE, Serum 14895-7
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

For Providers

Please login to order a test

Order a Test

© 2021 Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf