KRIBIOLISA Ivacaftor (KALYDECO) ELISA

Enzyme Immunoassay for the Quantitative Determination of Ivacaftor in human serum and plasma Ivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator used alone or in combination products to treat cystic fibrosis in patients who have specific genetic mutations that are responsive to the medication. Ivacaftor (also known as Kalydeco or VX-770) is a drug used for the management of Cystic Fibrosis (CF). It is manufactured and distributed by Vertex Pharmaceuticals. It was approved by the Food and Drug Administration on January 31, 2012. Ivacaftor is administered as a monotherapy and also administered in combination with other drugs for the management of CF. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year The method employs the competitive enzyme immunoassay technique. In the first step, samples and standards along with the Ivacaftor: HRP conjugate is pipetted and incubated. Both the standard/sample and Ivacaftor: HRP conjugate compete with CFTR (cystic fibrosis transmembrane conductance regulator (ATP- binding cassette sub-family C, member 7), which is pre-coated onto microwells. Free HRP conjugate will be removed by a washing step. In the second step, TMB substrate is added to microwells and color develops inversely proportionally to the amount of Ivacaftor present in the samples or standards. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.