The overall goal of this project is to develop a rapid, highly sensitive assay to detect the presence of anthrax. To achieve this goal we have developed a novel, proprietary technology with several advantages over currently used PCR-based methods. This technology, called SPIATM [single primer isothermal amplification] can amplify nucleic acids in an isothermal, homogeneous manner with expected sensitivity and specificity equal to and perhaps greater than PCR. Furthermore, the method does NOT suffer from the cross-contamination problems of PCR. In this Phase I proposal we expect to validate these claims and develop a test suitable for widespread use. Therefore we will a) optimize SPIATM and demonstrate sensitivity and specificity of SPIATM control sequences, b) demonstrate use of SPIATM using B. anthracis sequences, and c) validate SPIATM using B. subtills spores. In Phase II we will integrate this technology into detection device(s) with expanded field studies to evaluate sensitivity, specificity, etc.
