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A Low-cost Pathogen Detection System Is Proposed Comprising An Incubator-reader Unit As Well As A Low-cost Consumable Paper-based Indicator Test Strip.


A key desired outcome for this technology is to achieve AOAC certification of our instrument and methods under the AOAC Performance Tested Method Program. This milestone creates value for the product by enabling customer recognition and acceptance that our product carries an independent measure of quality assurance. To achieve this goal we will address four key development objectives during phase II that will prepare the product for testing after phase II. Phase I activities allowed us to de-risk the largest technical aspects of our product proposal. Phase II will further advance and customize the product for entry into specific target markets. To achieve these end goals for the phase II project we set out the following key objectives:Objective 1: Adapt single step enrichment growth medium for specific niche market applications.Our technology will use a broth to selectively grow harmful pathogens to a detectable level with our low cost device and consumables. Broths contain a number
of reagents and we will determine the broth formulation that best matches our food and environmental applications.Objective 2: Define Low-cost mPAD Design, Manufacturing and Packaging Specifications.Our paper-based test strips give the indication of a positive or negative response to the enrichment broth. We will determine the most efficient manufacturing conditions to generate reproducible test strips. The consumable product will also be optimized for cost and the packaging requirements. Initial shelf life and storage conditions will also be determined.Objective 3: Design and prototype an integrated platform for sample incubation and imaging.This objective encompasses our instrument development effort. Here we will focus on arriving at a prototype design that can be tested by early adopters.Objective 4: Perform in-house Method Validation.In preparation for applying for third party testing of our technology we will perform in-house validation study that sets the stage for handing off
our technology for AOAC evaluation. This activity will create an internal validation report with sub-reports including: inclusivity, exclusivity, specificity, sensitivity analysis.

Reilly, T. H.
Access Sensor Technologies, LLC
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