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Security feature for paper-based diagnostic device

IP.com Disclosure Number: IPCOM000239052D
Publication Date: 2014-Oct-06
Document File: 4 page(s) / 856K

Publishing Venue

The IP.com Prior Art Database

Abstract

A paper-based diagnostic device is a portable biomedical device made of paper, wax, and reagents that can analyze biochemical assays in test fluids such as blood, urine and saliva. The devices are small, lightweight, and low-cost and have potential applications as diagnostic devices in fields such as healthcare, military and homeland security. This idea proposes a method for securely handling the paper-based diagnostic device and processing data by adding security information on the device. The security information can be either visible or invisible to a naked eye, readable by a machine or a trained person. The security information could be a pattern or a signature. Once the security information is captured, it will be used for identification/authentication of device/patient, fraud prevention, test management, assisting advanced analysis, and facilitation of diagnostic data collection.

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Security feature for paper-based diagnostic device

A paper-based diagnostic device is a portable biomedical device made of paper, wax, and reagents that can analyze biochemical assays in test fluids such as blood, urine and saliva. The devices are small, lightweight, and low-cost and have potential applications as diagnostic devices in fields such as healthcare, military and homeland security.  This idea proposes a method for securely handling the paper-based diagnostic device and processing data by adding security information on the device. The security information can be either visible or invisible to a naked eye, readable by a machine or a trained person. The security information could be a pattern or a signature. Once the security information is captured, it will be used for identification/authentication of device/patient, fraud prevention, test management, assisting advanced analysis, and facilitation of diagnostic data collection.

Background

Fig.1. A prototype of paper-based diagnostic device made.

A paper-based diagnostic device (as shown in Fig. 1) is a small biomedical device made of paper, wax, and reagents that can analyze bioassays in test fluids such as blood, urine and saliva. The hydrophobic walls are made of wax that penetrates the entire thickness of the paper to create various fluidic components such as the test region, fluid entrance, transport channel, or mixer. Various reagents with different concentrations are pre-deposited on the test regions.  During the diagnostic process, the capillary force pulls the test liquid to multiple test regions and the pre-deposited reagents react with the test fluid. A signal is generated if the specific analyte is present in the test fluid.  The signal could be a color change where the color density varies with the concentration of analyte. The color change is captured by imaging device such as smart phone and is then processed by algorithm to calculate the concentration of each analyte based on calibration curve of the device. The diagnostics result and/or raw data (if the image processing and diagnostic analysis is done on the server side) are uploaded to a data server where the patient’s history is stored for inquiry and advanced data analytics that can help to early detect and prevent health conditions/disease. This integration of the device and service provides a complete, low cost solution for health monitoring as demonstrated in Fig. 2.

Fig. 2. Workflow of the paper-based diagnostic solution

The paper-based diagnostic devices can be used in both clinic and home environments. In the case of a clinic environment such as a walk-in clinic, a trained person such as a nurse can prepare and conduct tests for different patients.  The same person can also process and upload the results. In the home environment case, patients can purchase the device and conduct tests by themselves or a healthcare professional can visit patients’ home and provide diagnosis service with the device. No...