Description:
Background
NIAID supports integrated multiplex medical diagnostics platforms capable of simultaneously identifying multiple pathogens in clinical specimens (swabs, sputum, blood, serum, cerebrospinal fluid, urine, stool, etc.). Platforms that provide diagnostic information on potential early, non-specific symptoms and determine pathogen drug sensitivities are of high priority. Project Goal
The final integrated diagnostic product should be capable of aiding healthcare providers in diagnosing individuals exposed to and/or infected with infectious agents. The product should be developed with the ultimate goal of obtaining FDA clearance. Consequently the product should demonstrate sensitivity and specificity equivalent to or exceeding FDA-cleared tests for similar agents. The proposed diagnostic must provide rapid, shortened time from sample to diagnosis (30-40 minutes); offer high sensitivity and specificity; and be easy to use. Importantly, it should not incorporate nucleic acid amplification to detect pathogens, toxins or infectious diseases. The product should function as an integrated, closed sample-to-answer system with automated data analysis and output. It should be capable of integrating new assays and detection of modified or new targets and be cost-effective.
Phase I activities should include one or more of the following:
• Development and integration of novel methods for sample preparation and concentration into the platform.
• Development and integration of novel detection technologies into the platform that do not involve nucleic acid amplification.
• Development, optimization, integration, and validation of multiplex assays.
• Integration and validation of internal process controls.
• Development of software for controlling the platform, displaying the results of the diagnostic tests, and transferring results to laboratory information systems (LIMS).
Phase II activities should include one or more of the following:
• Continuation of Phase I activities.
• Process development for the manufacturing of diagnostic components, including Quality Assurance/Quality Control methods for reagent recovery, characterization, purification, identity, and stability.
• Validation of the integrated multiplex medical diagnostic platform. Tests for use on human samples may consider benchmarks required for FDA approval (http://www.fda.gov/cber/devices.htm).
