KRIBIOLISA Anti Glargine (LANTUS) ELISA

Introduction: Insulin glargine is produced by recombinant DNA technology. It is an analogue of human insulin made by replacing the asparagine residue at position A21 of the A-chain with glycine and adding two arginine to the C-terminus (positions B31 and 32) of the B-chain. The resulting protein is soluble at pH 4 and forms micro-precipitates at physiological pH 7.4. Small amounts of insulin glargine are slowly released from micro-precipitates giving the drug a long duration of action (up to 24 hours) and no pronounced peak concentration. Intended Use: This Anti-Glargine ELISA is used as an analytical tool for qualitative laboratory screening of presence or absence of antibodies to Glargine in serum and plasma. Principle: The method employs the qualitative sandwich enzyme immunoassay technique. A commercially available Glargine is pre-coated onto microwells. Samples and Controls are pipetted into microwells and antibodies to human Glargine present in the sample and controls are bound by Glargine. Then, a HRP (horseradish peroxidase) conjugated Glargine is pipette and incubated simultaneously with samples. After washing microwells in order to remove any non specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of antibodies to Glargine in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.