KRIBIOLISA™ Anti-Tenecteplase (TNKASE/METALYSE) ELISA

Enzyme Immunoassay for the Quantitative Determination of Antibodies to Tenecteplase in human serum and plasma. Tenecteplase is a fibrin-specific tissue-plasminogen activator. It binds to fibrin rich clots and cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action. This helps eliminate blood clots or arterial blockages that cause myocardial infarction. Tenecteplase binds to fibrin rich clots via the fibronectin finger-like domain and the Kringle 2 domain. The protease domain then cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action. FDA has approved Tenecteplase as one of the protein based therapies classified under hrombolytic agents. Commercially it is available as a drug under the trade name TNKase™ from Roche and Metalyse™ from BoehringerIngelheim. Safety considerations in the development of biologics are an important focus of regulatory guidelines. One of the major challenges is the immunogenicity profiling of these biologics. The potential risk of the patient developing an immune reaction during dosage regimen is to be assessed in detail Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. 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 quantitative sandwich enzyme immunoassay technique. Tenecteplase is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Tenecteplase present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Tenecteplase is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Tenecteplase in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.