Daratumumab ELISA (DARZALEX)

This Daratumumab ELISA is for determination of Daratumumab in human serum, plasma and cell culture supernatant.

Assay Background: Daratumumab, sold under the trade name Darzalex, is used for treatment of multiple myelomas. An IgG1k monoclonal antibody, Daratumumab binds to CD38. This causes cells to apoptose either by antibody-dependent cellular cytotoxicity or by CDC. Daratumumab was also given Orphan Drug Status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma.

Assay Principle: The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Daratumumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Daratumumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti- Daratumumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Daratumumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.