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[Immunoenzyme method of determining trace amounts of proinsulin in recombinant human insulin]
An enzyme immunoassay (ELISA) for the detection of human proinsulin has been developed based on the interaction of the absorbed proinsulin with the antiserum against the synthetic proinsulin C-peptide. In the presence of high concentrations of insulin, the sensitivity of the assay slightly decreases due to the competitive adsorption of insulin onto the polystyrene carrier with the binding constant 800-1000 times less than that of proinsulin. A method is proposed for the interpretation of ELISA data based on analysis of a weighed dry insulin sample, which enables the detection of a 0.02-0.1% admixture of proinsulin in the chromatographically purified recombinant human insulin.
An enzyme immunoassay (ELISA) for the detection of human proinsulin has been developed based on the interaction of the absorbed proinsulin with the antiserum against the synthetic proinsulin C-peptide. In the presence of high concentrations of insulin, the sensitivity of the assay slightly decreases due to the competitive adsorption of insulin onto the polystyrene carrier with the binding constant 800-1000 times less than that of proinsulin. A method is proposed for the interpretation of ELISA data based on analysis of a weighed dry insulin sample, which enables the detection of a 0.02-0.1% admixture of proinsulin in the chromatographically purified recombinant human insulin.