The ultimate goal of the program initiated with this proposal is the production of an instrument that can detect bacterial contamination of blood products immediately prior to use. This Phase I project will produce the prototype of a miniaturized bioassay system capable of simultaneously detecting the presence of 8 different bacteria at concentrations less than 1,000 CFU/ml in a single sample of less than 1 ml volume in 5 to 10 minutes. Operating costs are anticipated to be about $1.00 per analyte. Research International has recently discovered a unique and novel class of optical wave-guide shapes that are topologically ideal substrates for performing array-based fluoroimmunoassays. These unique wave-guides and associated fluidic controls will be designed as integral, molded-in components of a disposable plastic assay coupon. Storage of lyophilized reagents onboard the coupon will provide for a self-contained, single-use disposable as the only item that touches the sample The specific aims for Phase I are: Hardware: Design and build a prototype 4-channel waveguide and coupon. Design and build prototype opto-electronics and fluidics. Biochemistry: Demonstrate a method for applying antibodies to the waveguide. Develop assay protocols for two bacteria, one in platelets, one in RBCs Testing: Demonstrate a functional prototype system.
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