Description
Introduction:
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.
Intended Use:
The KRIBIOLISA Ivacaftor (KALYDECO& reg;) ELISA is used as an analytical tool for quantitative determination of Ivacaftor in human serum and plasma.
Principle:
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 (ATPbinding 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.
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