Enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of specific anti-Ustekinumab (Stelara®) antibodies in human serum and plasma. The Assay Genie Antibody to Ustekinumab (Stelara®) ELISA Kit is intended for the qualitative determination of Ustekinumab Anti-Drug Antibodies (ADA) in serum and plasma. It is for professional use only.

The Assay Genie Antibody to Ustekinumab (Stelara®) ELISA is a sandwich assay for the determination of antibodies against Ustekinumab in serum and plasma samples. During the first incubation period, anti-Ustekinumab antibodies in patient serum/ plasma samples are captured by the Ustekinumab (Stelara®) coated on the wall of the microtiter wells. After washing away the unbound components from samples, a peroxidase labelled specific conjugate is added to each well and then incubated. After a second washing step, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of Ustekinumab in sample.

Ustekinumab is a fully human monoclonal antibody that binds with high specificity and affinity to the cytokines interleukin (IL)-12 and IL-23, thereby suppressing IL-12- and IL-23-mediated inflammation associated with psoriasis. Ustekinumab is a human IgG1-kappa monoclonal antibody designed to interfere with the triggering of the body's inflammatory response through the suppression of certain cytokines. Specifically, ustekinumab blocks interleukin IL-12 and IL-23 by binding with high affinity and specificity to the p40 subunit of IL-12 and IL-23, therefore disrupting the proinflammatory pathway that contributes to several chronic diseases. In a more minor role, ustekinumab also interferes with the expression of monocyte chemotactic protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-alpha), interferon-inducible protein-10 (IP-10), and interleukin IL-8.

Ustekinumab is used as a treatment for plaque psoriasis and a particular type of arthritis (psoriatic arthritis). Furthermore, ustekinumab is used for certain bowel conditions including Crohn's disease and ulcerative colitis. Ustekinumab (STELARA®) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy. It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab (STELARA®) is the only FDA-approved medicine that targets IL-12 and IL-23, which are thought to be associated with gastrointestinal inflammation in Crohn's disease.

As with any biologic therapy, immunogenicity, in the form of anti-ustekinumab antibodies, occurs with following administration. The demonstration of anti-ustekinumab antibodies during treatment with ustekinumab (Stelara®) is a major concern. Monitoring for the presence and/or quantitation of specific antibodies during clinical trials is an important issue for treatment regimen follow-up. The Assay Genie Anti-Ustekinumab ADA Qualitative ELISA Kit can be efficiently used for monitoring ustekinumab-specific antibodies in biological samples and are for research use only. With this Assay Genie ELISA test, ustekinumab anti-drug antibodies (ADA) can be detected.

Stelara® is a registered trademark of Johnson and Johnson, Inc.