Numerous devices are becoming available for collection and testing of oral fluids. The Intercept® device (Orasure Technologies), along with its associated immuno-assays, is one of the first to be approved for commercial sale in the United States. This chapter presents clinical and nonclinical information on the principles of operation and performance of the Intercept device. This chapter specifically reviews the physiology of the oral cavity as it relates to the use of the Intercept device to collect specimens for analysis. Once a sample is prepared for analysis, performance data for numerous assays are reviewed. This includes analytical performance of various aspects of Intercept immuoassays used, including cross-reactivity, precision, limits of detection, and effects of interferents. Finally, clinical field data are included demonstrating the use of the Intercept device from large population prevalence studies.
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