Diagnostic assay methods using assay device having microreactor
Inventors
Choi, Young Ho • Back, Jungho • Kim, Hyoungsoo • Chon, Hanmaru • Jang, Myungkyu • KIM, Hyeon Suk • Kim, Myoun Woo • Park, Hyewon • Lee, Suji • Kim, Olivia Haejeong
Assignees
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Publication Number
US-12044679-B2
Publication Date
2024-07-23
Expiration Date
Abstract
Diagnostic assay devices for detecting the presence of an analyte in a sample solution may comprise a microreactor configured to form a sample solution containing the analyte, flow the sample solution therethrough in a first direction to form an analyte-capture molecule complex, and transfer the sample solution to an absorbent strip pad configured to flow therethrough, in a second direction crossing the first direction, the sample solution including the analyte-capture molecule complex and indicate a presence of the analyte-capture molecule complex. The diagnostic devices may be used, for example, to identify the presence of SARS-Cov2, RSV, influenza A, influenza B or other pathogens in samples from patients.
Core Innovation
The diagnostic assay device comprises a vertically arranged microreactor fluidly connected to an absorbent strip pad for lateral flow. A sample solution contacts capture and detection molecules associated with a porous wicking filter within the reaction chamber to form an analyte-capture molecule complex. The specimen-receiving chamber concentrates freshly extracted analyte near the filter, and the complex subsequently transfers to a test line on the absorbent strip pad for visual detection.
The device configuration controls reaction residence time and sensitivity by positioning capture and detection reagents near the specimen-receiving chamber and defining filter capacity. Assays demonstrate sensitivity improvements and higher signal generation compared to standard lateral-flow assays for target analytes. The background section problem is not explicitly described in patent.
Claims Coverage
The claims identify two independent claims comprising four inventive features directed to analyte capture, reagent positioning, filter capacity relationships, and visual detection across a vertically arranged microreactor and an absorbent strip pad.
Vertically arranged microreactor and porous wicking filter
Independent claims 1 and 23 recite a specimen-receiving chamber vertically above and fluidly connected to a reaction chamber housing a porous wicking filter that carries capture molecules and detection molecules.
Specimen-receiving chamber analyte concentration and filter capacity
Both independent claims recite upper and lower portions of the specimen-receiving chamber where sample solution initially has higher analyte concentration in the lower cavity, with the porous wicking filter holding a volume about equal to or less than the lower cavity.
Transfer to an absorbent strip pad and test line
Both independent claims recite an absorbent strip pad in contact with the porous wicking filter to transfer sample solution containing the analyte-capture molecule complex to binding molecules at a test line.
Visual detection of the analyte
The independent claims recite visualizing a detection component or colorimetric component of the analyte-capture molecule complex bound at the test line to identify analyte presence in the specimen.
The independent claims cover diagnostic methods utilizing microreactor-based analyte capture and horizontal absorbent strip transfer for test-line visual identification, characterized by filter volume holding capacities and reagent arrangements.
Stated Advantages
The summary reports sensitivity improvements over standard lateral-flow assays: 16-fold for SARS-CoV-2, 8-fold for RSV, 5-fold for influenza A, and 10-fold for influenza B.
Experiments show higher signal generation and stronger signals across tested concentrations when capture and detection reagents are concentrated near the specimen-receiving chamber compared to standard assays.
Documented Applications
Diagnostic assays for identifying analytes in swab-derived sample specimens, specifically SARS-CoV-2, respiratory syncytial virus (RSV), influenza A, and influenza B antigens.
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