Rituximab (Rituxan®) is a chimeric mouse/human monoclonal antibody used for treating B cell malignancy, autoimmune conditions, and graft rejection by depleting B cells from the body.
Intended Use
This Rituximab (Rituxan®) Immunogenicity BioAssay™ ELISA Kit is used for the qualitative determination of Rituximab binding antibodies in serum and plasma.
Precision
Intra-assay CV: <10% Inter-assay CV: <10%.
Test Principle
This immunogenicity assay employs the bridging ELISA technique. Capture antibody is precoated onto a 96 well microplate. Quality control and test samples are pipetted into the appropriate wells. Anti-Rituximab present in biological matrices is bound by the immobilized capture antibody. After washing away any unbound substances, secondary antibody is added to the wells and after a final wash a detection reagent is added. The plate is washed to remove any unbound antibody-enzyme reagent and a substrate solution is added to the wells for color development. The color development is proportional to the amount of anti-Rituximab present in test samples. Four levels of QC samples give a qualitative reference signal which can be used to determine the level of antiRituximab antibody in the unknown samples. The color development is stopped and the intensity of the color is measured.
Kit Components
Coated microtiter plate, 96 wells (1x8 strips) QC samples, 5x50ul Wash buffer, 10X, 1x25ml Assay buffer, 1x50ml Detection reagent, 1000X, 1x17ul TMB, 1x12ml TMB stop solution 1x12ml
Storage and Stability
Store kit components at -20°C unless specified otherwise. Unopened kit is stable for 6 months after receipt. For maximum recovery of product, centrifuge small tubes on pulse setting prior to opening.