High-Accuracy Statistical Detection and Discernment of Pathogens, Substances, and Biomarkers Using Binary Classifiers Operating on Processed Measurements from Groups of Less-Accurate Sensors

Abstract

This invention provides novel statistical processing approaches on measurements from diverse or varied sensors to collectively implement high-accuracy testing for detections and / or discernments of pathogens, substances, and / or biomarkers. For example, a group of inexpensive sensors can approach, match, or exceed the performance of existing high-accuracy methods. In an implementation, measurements are obtained from disposable optical and / or bioFET sensors arrayed on a substrate using printing techniques. In an example application, the invention operates together with or within a platform technology comprising a rich ability to flexibly perform, create, deploy, maintain, and update a range of panels, assay, array, and / or test sequences for a wide range of substances and pathogens using a wide range and large number of collocated highly-selective sensors and supplemental sensors (such as temperature, pH, selective ions, etc.). The invention addresses many problematic aspects of field testing for food safety, water safety, epidemic outbreaks, routine diagnosis, and disease monitoring.

Description

CROSS-REFERENCE TO RELATED CASES[0001]The present application is a continuation of U.S. application Ser. No. 13 / 761,142, filed on Feb. 6, 2013, which claims priority to Provisional U.S. App. Nos. 61 / 595,651 and 61 / 595,681, both filed on Feb. 6, 2012, as well as Provisional U.S. Patent App. Nos. 61 / 595,692, 61 / 595,973, and 61 / 596,016, all filed on Feb. 7, 2012, and Provisional U.S. App. Nos. 61 / 614,229 and 61 / 614,253, both filed on Mar. 22, 2012, which are all hereby incorporated herein by reference in their entireties.COPYRIGHT & TRADEMARK NOTICES[0002]A portion of the disclosure of this patent document may contain material, which is subject to copyright protection. Certain marks referenced herein may be common law or registered trademarks of the applicant, the assignee or third parties affiliated or unaffiliated with the applicant or the assignee. Use of these marks is for providing an enabling disclosure by way of example and shall not be construed to exclusively limit the scope o...

AI Technical Summary

Benefits of technology

The invention provides a removable medium apparatus for providing replaceable sensing function to an external base unit. The apparatus includes a substrate with isolated selective sensors, each sensor comprising at least one layer of a selective detection material that responds to a target agent in a fluid analyte. The substrate also has a readable medium attached to it with an alignment arrangement for aligning with the base unit. The apparatus can be used in various fields such as food, environmental, or human samples. The sensor device also includes a base unit with computational processor and receiving arrangement for receiving and supporting the removable medium apparatus. The sensor device can further include a medium reader for reading encoded data on the removable medium apparatus and a fluidic interface arrangement for connecting to the removable medium apparatus.

Problems solved by technology

Humans, animals, crops, and the general environment are subject to many threats from pathogens, toxins, and disease.

Although competition among these can in principle reduce costs, in practice the diversity can increase costs and continually set the expenditure bar higher as one or another approach can do a superior job in some aspects but not other aspects.

The volumes of manufacturing for the large diversity of evolving laboratory machines and materials are small, preventing meaningful economies of scale from being achieved or even envisioned, these high costs forces geographical and institutional centralization of testing with tremendous throughput, logistic, and economic barriers to the needed levels and most logical settings for monitoring, testing, and diagnosis.

Outbreaks new of food-borne diseases in packaged, processed, and even locally produced food are ever-present in the developed world (costing lives, health, vast waste, and hundreds of millions of dollars) and of course viciously plague the undeveloped world (costing vast numbers of lives, health, and impeded economic development).

Similarly, water quality has also been threatened by contamination, and as populations increase in areas involving farming, industry, mining, natural-gas / shale-oil “tracking,” etc., the concerns are becoming more acute.

Water quality is also involved in food safety as contaminated wash or process water can and has cause both biological and chemical food safety incidents.

Further, both food and water are perpetual targets for terrorism, contamination by industrial dumping, mining, fossil-fuel drilling, waste-landfill leakage, waste-water handling failures, etc.

As a result, again there is considerable exposure to food contamination.

There far is less ability and framework to practically impose regulations, monitoring, and procedures than there are for the entities and steps in FIG. 2a, and as a result, again there is considerable exposure to contamination.

In many cases, however, the approach of FIG. 3b is not possible or not realistic.

For example, the pathogen can have already been wiped out by the immune system, or can be in a part of the organism from which obtaining a sample is difficult, or the pathogen can be too rarefied within the organism to be adequately captured in the sample.

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