SBIR-STTR Award

A new, rapid and sensitive test method for the detection of erythromycin in animal-derived products such as milk and mcat will be developed based on immunoassaymethodology. Directed synthetic techniques will be used to prepare the immunogcns necessary to develop antibodies, both monoclonal and conventional, with the broadest recognition for all drugs in the macrolidc class of antibiotics as well as the most important active metabolites. The limit of sensitivity will be at least oneug/ml, the amount of drug found in human samples.Applications:This project leads to the development of the materials required for an immunoassay test system to detect and monitor the levels of erythromycin which may remain in food products. Antibiotics arc used routinely in animal feed and in the treatment of a large variety of animal diseases. Concerns about the impact on human health due to the presence of antibiotics in the environment have been increasing. Since it is desirable to minimize the amount of antibiotics in the environment, the tests developed in this project have commercial potential.

A new rapid test method to detect erythromycin to levels of 0.1 to 0.01 ppm in animal derived products such as milk and meat will be developed based on a novel wimmunotrapw assay system. Prototype design and development will be done with the antibodies and other materials produced during Phase I. Techniques and materials used to prepare immunogens will be modified to increase the probability of obtaining murine monoclonal antibodies with high affinity. Antibodies will be selected for their specificity for erythromycin, as well as for broader recognition for antibiotics of the macrolide class. The erythromycin system will be used as a model for assays to detect other macrolides.Applications:As a result of this effort, a new assay system to detect erythromycin in milk to levels of 0.01 to 0.1 will be developed. A prototype product based on this methodology and useful in processing laboratories will be ready for field trials. Favorable acceptance of the prototype would be the first step towards commercialization. Feasibility studies for a test with sensitivity less than 0.01 ppm will be done.