KRIBIOLISA™ Vedolizumab (ENTYVIO™) ELISA

Introduction:

Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohn's disease for patients who have had an inadequate response with, lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target, α4β7 integrin, vedolizumab reduces inflammation in the gut.

Intended Use:

The KRIBIOLISA™ Vedolizumab (ENTYVIO™) ELISA is used as an analytical tool for quantitative determination of Vedolizumab (ENTYVIO™) in serum, plasma and cell culture supernatant.

Principle:

The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Vedolizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Vedolizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Vedolizumab antibody 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 Vedolizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.