Leadgene Indoxyl Sulfate (IS) ELISA Kit represents the first CE-registered protein-bound uremic toxin (PBUT) detection IVD available globally. Chronic kidney disease (CKD) manifests as a gradual decline in kidney function. CKD can lead to the accumulation of waste and uremic toxins in the bloodstream when the kidneys' filtration function is compromised. Among various uremic toxins, protein-bound uremic toxins (PBUTs) – including indoxyl sulfate (IS) – pose significant threats to CKD patients. As PBUTs accumulate, they further impair renal function and adversely affect the cardiovascular system. This makes the timely detection of PBUTs crucial for accurately monitoring the glomerular filtration rate. Regrettably, the standard PBUT detection, LC-MS/MS-based methods, necessitates sophisticated, expensive equipment, and can only be performed by certified technicians. Leadgene's pioneering work in antibody discovery has led to the development of antibodies targeting small molecules. These patented antibodies form the basis of the Leadgene Indoxyl Sulfate (IS) ELISA Kit. This kit has been approved by the Taiwan Food and Drug Administration (TFDA) as a Class III in vitro diagnostic device (MOHW-MD-No. 007625). As the first patented product of its kind globally, it aims to provide new clinical detection solutions. This innovation is expected to enhance the prevention and management of kidney disease worldwide, reduce healthcare costs, and improve social welfare.
