Description：Enzyme Immunoassay for quantitative detection of Obinutuzumab （Gazyva） in serum and plasma.
Obinutuzumab is a fully humanized monoclonal antibody that binds to an epitope on CD20 that partially overlaps with the epitope recognized by rituximab.
Obinutuzumab binds to CD20 on B cells and causes these cells to be destroyed by engaging the adaptive immune system, directly activating intracellular apoptosis pathways, and activating the complement system.
Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well.
About the kit：
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are between 85 - 115％
- Ready to use with a standard protocol with break-apart pre-coated wells
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.
- Shelf life： 1 year
The method employs the quantitative sandwich enzyme immunoassay technique.
Antibodies to Obinutuzumab are pre-coated onto microwells.
Samples and standards are pipetted into microwells and human Obinutuzumab present in the sample are bound by the capture antibody.
Then, a HRP （horseradish peroxidase） conjugated Anti-Obinituzumab 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 Obinutuzumab in the sample.
Color development is then stopped by addition of stop solution.
