Tocilizumab (Actemra®) BioAssay™ ELISA Kit

Tocilizumab (Actemra®) is an immunosuppressive humanized monoclonal antibody drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of arthritis|in children. Tocilizumab binds the interleukin-6 receptor (IL-6R) thus blocking the signaling caused by interleukin 6 (IL-6). IL-6 is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases.||Sample Type:|Serum and plasma||Intended Use:|This is designed to measure free Tocilizumab with high specificity and sensitivity.||Sensitivity:|1.5ng/ml ||Recovery:|250ng/mL of Tocilizumab was spiked in 10 lots of human serum. Recovery ranges are from 88-112% with an average recovery of 104%.||Precision: |Intra-assay CV: <10% |Inter-assay CV: <10%. ||Specificity:|hIgG1, Rituximab, and Infliximab prepared at 250ng/mL were assayed and exhibited no cross-reactivity or interference.||Test Principle:|This assay employs the sandwich enzyme immunoassay technique. Anti- Tocilizumab is coated onto a 96 well microplate. Calibrator and test samples are pipetted into the appropriate wells. Tocilizumab present in biological matrices is bound by the immobilized anti- Tocilizumab antibody. After washing away any unbound substances, enzyme linked anti- Tocilizumab antibody is added to the wells. This antibody is developed and purified specifically against Actemra® (domain residing in Fc portion of the Actemra® molecule). 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 Tocilizumab present in test samples. The color development is stopped and the intensity of the color is measured.||Kit Components:|Coated microtiter plate, 1x96 wells |Calibrator diluent, 1x1.8ml|Calibrator (0.5mg/mL), 1x12ul|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.