Description
Introduction:
The KRIBIOLISA ELISA kits are used for assessing the specific biomarker in samples analytes which may be serum and cell culture supernatant as validated with the kit. The kit employs a blocking ELISA technique which engages the blocking pathway to estimate the neutralizing antibodies. Dulaglutide, marketed by Eli Lilly as Trulicity, is a once-weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist designed using recombinant DNA technology; it has been approved as an adjunct therapy to diet and exercise in the management of 2 diabetes (T2DM).5 Dulaglutide was initially approved by the FDA in 2014, and in February 2020 was approved for use in patients with T2DM and multiplecardiovascular risk factors for the prevention of cardiovascular events. It is the first T2DM drug approved to reduce major adverse cardiovascular events (MACE) risk in primary and secondary prevention populations. A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens and are produced naturally by the body as part of its immune response. Their production is triggered by both infections and vaccinations against infections. In an immunogenetic context it will bind to a drug and neutralize its therapeutic effect.
Intended Use:
The KRIBIOLISA Neutralizing Antibodies to Dulaglutide (Trulicity) ELISA kit is used as an analytical tool for the qualitative detection of neutralizing antibodies against Dulaglutide in serum or plasma.
Principle:
The method employs sandwich ELISA technique. The protein-protein interaction between HRP-Dulaglutide and Anti-GLP1 can be blocked by Dulaglutide. The neutralizing antibodies against Dulaglutide binds to Dulaglutide and thus a competitive inhibition is created. Samples and controls are pipetted in a blank microtitre plate and incubated with neutralizing antibody to Dulaglutide (NAb) and Dulaglutide. This complex of bound and unbound Dulaglutide is then incubated with HRP
conjugated Dulaglutide protein. The unbound Dulaglutide will bind to the Anti-GLP1. The bound Nab-Dulaglutide will not bind to the HRP conjugated Dulaglutide. This complex solution of bound antibodies to Dulaglutide and unbound Dulaglutide is then pipetted into Anti GLP1 coated microplate. After washing, the substrate solution (TMB) is added to the microwells. Post incubation, color develops proportionate to the amount of bound Dulaglutide. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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