SERODIAGNOSTIC TESTING DEVICE AND SYSTEM FOR EARLY-STAGE LYME DISEASE USING A MULTIPLEXED IMMUNOASSAY

    公开(公告)号:US20210382052A1

    公开(公告)日:2021-12-09

    申请号:US17285906

    申请日:2019-10-18

    Abstract: A multiplexed vertical flow serodiagnostic testing device for diseases such as Lyme disease includes one or more multi-piece cassettes that include vertical stacks of functionalized porous layers therein. A bottom piece of the cassette includes a sensing membrane with a plurality of spatially multiplexed immunoreaction spots or locations. Top pieces are used to deliver sample and/or buffer solutions along with antibody-conjugated nanoparticles for binding with the immunoreaction spots or locations. A colorimetric signal is generated by the nanoparticles captured on the sensing membrane containing disease-specific antigens. The sensing membrane is imaged by a cost-effective portable reader device. The images captured by the reader device are subject to image processing and analysis to generate positive (+) or negative (−) indication for the sample. A concentration of one or more biomarkers may also be generated. The testing device is rapid, simple, inexpensive, and allows for simultaneous measurement of multiple antibodies and/or antigens making it an ideal point-of-care platform for disease diagnosis.

    COMPUTATIONAL SENSING WITH A MULTIPLEXED FLOW ASSAYS FOR HIGH-SENSITIVITY ANALYTE QUANTIFICATION

    公开(公告)号:US20220299525A1

    公开(公告)日:2022-09-22

    申请号:US17612575

    申请日:2020-05-22

    Abstract: A system for detecting the presence of and/or quantifying the amount or concentration of one or more analytes in a sample includes a flow assay cartridge having a multiplexed sensing membrane that has immunoreaction or biological reaction spots of varying conditions spatially arranged across the surface of the membrane defining an optimized spot map. A reader device is provided that uses a camera to image the multiplexed sensing membrane. Image processing software obtains normalized pixel intensity values of the plurality of immunoreaction or biological reaction spots and which are used as inputs to one or more trained neural networks configured to generate one or more outputs that: (i) quantify the amount or concentration of the one or more analytes in the sample; and/or (ii) indicate the presence of the one or more analytes in the sample; and/or (ii) determines a diagnostic decision or classification of the sample.

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