Omalizumab (Xolair®) is a recombinant DNA-derived humanized IgG1k monoclonal antibody that binds human immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma and Chronic Idiopathic Urticaria (CIU). Omalizumab inhibits the binding of IgE to IgE receptor (FceRI) on the surface of mast cells and basophils therebylimiting the release of mediators of the allergic response from the FceRI bearing cells.
Sample Type:Serum and plasma
Intended Use:For the quantitative determination of Omalizumab in serum and plasma.
Sensitivity:1.5ng/ml
Recovery:250ng/mL of Omalizumab was spiked in 10 lots of human serum. Recovery ranges are from 95-112% with an average recovery of 104%.
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- Omalizumab is coated onto a 96 well microplate. Calibrator and test samples are pipetted into the appropriate wells. Omalizumab present in biological matrices is bound by the immobilized anti- Omalizumab antibody. After washing away any unbound substances, enzyme linked anti- Omalizumab antibody is added to the wells. This antibody is developed and purified specifically against Xolair® (domain residing in Fc portion of the Xolair® 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 Omalizumab present in test samples. The color development is stopped and the intensity of the color is measured.
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.
