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Immunofixation, Isatuximab-Specific, Serum

Important Note

Cerner Order Name: Send Out:Other

LabCorp Test ID 123062

Note: Only for patients undergoing therapeutic monoclonal antibody (mAbs) drug treatment with isatuximab (SARCLISA®)

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

Use

Detect and identify monoclonal immunoglobulin gammopathies in the presence of therapeutic monoclonal antibody (mAbs) drug treatment with isatuximab (SARCLISA®), a human IgG1 kappa mAb, which migrates in the electrophoretic gamma globulin zone of the electrophoresis gel. In this laboratory procedure, the isatuximab in vitro interference is removed using an anti-isatuximab antibody reagent. This procedure will characterize the specific light and heavy chain components of a monoclonal protein without isatuximab interference.

Custom Additional Information

SARCLISA® (isatuximab) is a human monoclonal IgG Kappa 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 isatuximab reagent allows the laboratory to distinguish isatuximab interference from endogenous M protein1 on Hydragel IF assay.

A negative immunofixation result with HYDRASHIFT 2/4 isatuximab may suggest a complete response (CR) or stringent complete response (sCR) to therapy along with other clinical assessment for patients receiving isatuximab.2

Icon & Photos

Gold Top (SST-Gel)

Specimen Requirements

Preferred:
Container/Tube: Gold Top (SST-Gel)
Minimum Volume: 2 mL
Collection Instructions: Separate serum from red cells.
Also Acceptable:
Container/Tube: Other SST Gel, Red Top Tube

Specimen Stability

Temperature Period
Room temperature 14 days
Refrigerated 14 days
Frozen 14 days

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 isatuximab gel shift assay uses an anti-isatuximab antibody to allow for the migration of isatuximab/anti-Isatuximab complexes away from the gamma globulin zone on IFE, toward the alpha-1-globulin fraction, thus removing IgG kappa interference in the gamma globulin zone caused by isatuximab in the patient's serum.

CPT

82784 (x3)

86334

Test Alias

IFE
IEP
Immunoelectrophoresis, Serum

Report Available

4-8 days