Biosensor platform for rapid diagnostic testing
Inventors
Hnasko, Robert M. • Haff, Ronald P. • Jackson, Eric S.
Assignees
United States, Represented By Secretary Or Agriculture AS • US Department of Agriculture USDA
Publication Number
US-12239975-B2
Publication Date
2025-03-04
Expiration Date
2039-06-18
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Abstract
The biosensor platform is a rapid point-of-care (POC) device wherein detection of a target substance is performed in a single step using a fully integrated disposable biosensor test system. In one embodiment, the system comprises a horizontally oriented multi-strip test cassette. A user initiates the test by depositing an analyte onto an immunochromatographic test strip sandwiched between a (top) cassette lid and a (bottom) slotted cassette tray. The test strip is held in place by at least one horizontally extending self-adjusting flex plate. The system is structured so that as the analyte flows through the test strip, the analyte reacts with a reagent in the test strip to indicate a presence or absence of the targeted substance as the test strip is held in place by the self-adjusting flex plate.
Core Innovation
The invention is a modular biosensor platform designed as a rapid point-of-care (POC) device for detecting target substances in analytes through a single-step immunochromatographic assay. It features fully integrated, disposable biosensor test systems which include components such as a capsule sleeve holding a liquid capsule, a test strip chamber to accommodate a standard immunochromatographic test strip, a restrictor port to control liquid flow, and a resilient flex plate to hold the test strip in place and facilitate analyte flow through the test strip materials. The system enables the analyte to flow via capillary action through the test strip, reacting with reagents to indicate presence or absence of the targeted substance, readable through a test window.
The problem addressed by the invention stems from the limitations of current lateral flow test devices which require multi-step procedures involving separate components like immunochromatographic test strips, liquid extraction buffers, and liquid transfer pipettes. These multi-step processes are prone to user error, particularly in precise liquid delivery, are cumbersome in field locations, and often lack integration. Specifically, tests that require extraction of solid samples into liquids or pH buffering suffer from imprecise and poorly integrated components, hindering ease of use and reliability in POC or field settings.
The innovation overcomes these issues by integrating the test strip with sample extraction and liquid delivery components into a small, portable, disposable platform that allows rapid and accurate single-step testing with minimal training. The biosensor platform accommodates liquid or solid samples, is compatible with standard lateral flow test strip dimensions, and supports interchangeable components for various test and buffer combinations. The platform also accommodates digital reading tools for rapid electronic data recording and analysis.
Claims Coverage
The claims disclose one independent claim encompassing a biosensor system integrating a multilayer immunochromatographic test strip held securely by flex plates within a cassette for analyte testing.
Integrated test strip held by flex plate pressure
The system includes a horizontally extending cassette lid and bottom tray that sandwich a multilayer immunochromatographic test strip. At least one flex plate extends downward from the cassette lid to exert pressure on the test strip, securing it in place during analyte flow.
Self-adjusting pressure on overlapping test strip layers
The flex plate applies pressure specifically on the overlap of at least two layers of the test strip and extends horizontally parallel to the cassette lid, providing self-adjusting vertical pressure to facilitate fluid flow without damaging test materials.
Dual flex plates positioning for enhanced strip stability
The system can include first and second flex plates positioned at opposite ends of the test strip held in tandem, sandwiching the strip between them and an elevated base on the cassette tray.
Test results visibility and automated reading capability
The cassette lid includes a results display window between flex plates that allows the test strip, particularly the test and control lines, to be visible. The system supports access by automated test result detection devices through this window.
Multiple test slot configuration for simultaneous testing
The biosensor system is configured with multiple test slots arranged in parallel, each accommodating a single test strip, enabling multiple simultaneous tests within one cassette.
Collectively, the inventive features encompass a modular biosensor cassette that securely holds immunochromatographic test strips with flexible pressure plates, enables reliable capillary flow of analyte through multilayer test strips, visually presents results through a dedicated window, supports automated result detection, and allows multiple simultaneous tests by configuring multiple parallel test slots.
Stated Advantages
Provides rapid and accurate test results in a single step with minimal end-user training.
Integrates sample extraction and liquid delivery with immunochromatographic test strips in a portable disposable format.
Reduces end-user error by securing test strips with self-adjusting flex plates that ensure firm contact without damaging test materials.
Enables compatibility with standard lateral flow test strip dimensions and interchangeable components for different tests.
Supports digital result reading and data recording through configurable test result windows.
Documented Applications
Rapid point-of-care testing for detection of allergens, pathogens, toxins, adulterants, and environmental contaminants in health and food safety contexts.
Farm-to-fork applications requiring detection of target analytes from solid and liquid substrates including agricultural samples.
Testing scenarios where sample preparation requires solid-to-liquid extraction or pH buffering followed by precise volume delivery to test strips.
Simultaneous multi-test testing to confirm results or compensate for nonfunctional individual tests.
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