Abstract: The compositions and methods described herein relate to the direct collection of a fixed specimen volume using a dual pad comprising a first hydrophilic sample pad and a second hydrophobic sample pad. The fixed specimen volume collected on the first hydrophilic sample pad is prevented, or blocked, from saturating anything other than the hydrophilic sample pad by the second hydrophobic sample pad. But when the dual pad is wetted by a chase buffer that releases the specimen in whole or in part and renders the second hydrophobic sample pad permeable, the wetted specimen sample is introduced to a conjugate pad and test membrane to provide for analysis of one or more components within the specimen sample.

Abstract: A two-component system and device for efficient analysis of Nucleic Acid Amplification Tests (NAAT) on a cartridge that is portable, low cost, delivers rapid results with direct sample application, minimal sample volume, and has a user-friendly interface. The system and device can be used to perform NAAT reactions, either thermal or isothermal and either in single-plex or multi-plex, on a sample within a single-use test cartridge that is integrated for use with a reusable separately housed amplification module and analysis module to generate test results.

Abstract: Embodiments are directed to use of a rapid-test-validation computing device to determine if a result of a rapid test device is valid and identify the result. The rapid-test-validation computing device captures images of the rapid test device and employs a first artificial intelligence mechanism to determine if the rapid test device is properly aligned in the images. The rapid-test-validation computing device then employs a second artificial intelligence mechanism to determine if a result of the rapid test device is valid or invalid. If the result is valid, the rapid-test-validation computing device employs a third artificial intelligence mechanism to determine and present an objective output of the rapid test device result to a user; otherwise, the rapid-test-validation computing device presents a notification to the user that the rapid test device result is invalid.

Abstract: A lateral flow assay cassette comprising a swab holder is provided herein. Also provided are kits comprising the lateral flow assay cassette and methods of detecting an analyte.

Abstract: Embodiments are directed to use of a rapid-test-validation computing device to determine if a result of a rapid test device is valid and identify the result. The rapid-test-validation computing device captures images of the rapid test device and employs a first artificial intelligence mechanism to determine if the rapid test device is properly aligned in the images. The rapid-test-validation computing device then employs a second artificial intelligence mechanism to determine if a result of the rapid test device is valid or invalid. If the result is valid, the rapid-test-validation computing device employs a third artificial intelligence mechanism to determine and present an objective output of the rapid test device result to a user; otherwise, the rapid-test-validation computing device presents a notification to the user that the rapid test device result is invalid.

Abstract: The present invention relates to compositions and methods involving diagnostic tests with multiple test antigens. The present invention involves the expanded use of test antigens as cross-reactive control antigens (CCAs). The invention advantageously provides for enhanced test results analysis by simultaneously providing both test antigen and CCA signal results. These results, in turn, allow useful sample comparison and cross-reference between samples to more accurately identify and verify the fidelity of test results obtained for multiple infective agents at once. The present invention may include compositions and methods for detecting infection by Zika virus or another flavivirus, and may distinguish between infections caused by genetically similar agents.

Abstract: The present disclosure relates to a machine learning (ML)-implemented assay for Lyme disease that detects antibodies for multiple Lyme disease associated antigens, as well as kits and systems for implementation of such an assay.

Abstract: A lateral flow assay cassette including a vertical swab holder is provided herein. Also provided are kits including the lateral flow assay cassette and methods of detecting an analyte using the lateral flow assay cassette.

Abstract: Embodiments are directed to use of a rapid-test-validation computing device to determine if a result of a rapid test device is valid and identify the result. The rapid-test-validation computing device captures images of the rapid test device and employs a first artificial intelligence mechanism to determine if the rapid test device is properly aligned in the images. The rapid-test-validation computing device then employs a second artificial intelligence mechanism to determine if a result of the rapid test device is valid or invalid. If the result is valid, the rapid-test-validation computing device employs a third artificial intelligence mechanism to determine and present an objective output of the rapid test device result to a user; otherwise, the rapid-test-validation computing device presents a notification to the user that the rapid test device result is invalid.

Abstract: A lateral flow assay cassette comprising a swab holder is provided herein. Also provided are kits comprising the lateral flow assay cassette and methods of detecting an analyte.

Abstract: Embodiments are directed to use of a rapid-test-validation computing device to determine if a result of a rapid test device is valid and identify the result. The rapid-test-validation computing device captures images of the rapid test device and employs a first artificial intelligence mechanism to determine if the rapid test device is properly aligned in the images. The rapid-test-validation computing device then employs a second artificial intelligence mechanism to determine if a result of the rapid test device is valid or invalid. If the result is valid, the rapid-test-validation computing device employs a third artificial intelligence mechanism to determine and present an objective output of the rapid test device result to a user; otherwise, the rapid-test-validation computing device presents a notification to the user that the rapid test device result is invalid.

Abstract: The present invention relates to compositions and methods involving diagnostic tests with multiple test antigens. The present invention involves the expanded use of test antigens as cross-reactive control antigens (CCAs). The invention advantageously provides for enhanced test results analysis by simultaneously providing both test antigen and CCA signal results. These results, in turn, allow useful sample comparison and cross-reference between samples to more accurately identify and verify the fidelity of test results obtained for multiple infective agents at once. The present invention may include compositions and methods for detecting infection by Zika virus or another flavivirus, and may distinguish between infections caused by genetically similar agents.

Abstract: A device for performing a multiplex lateral flow immunoassay is provided in which a liquid sample, such as a biological sample, is simultaneously tested for the presence of multiple analytes of interest. Methods that employ the device in the simultaneous detection of multiple analytes of interest within a liquid test sample are also provided.

Abstract: The present invention relates to compositions and methods involving diagnostic tests with multiple test antigens. The present invention involves the expanded use of test antigens as cross-reactive control antigens (CCAs). The invention advantageously provides for enhanced test results analysis by simultaneously providing both test antigen and CCA signal results. These results, in turn, allow useful sample comparison and cross-reference between samples to more accurately identify and verify the fidelity of test results obtained for multiple infective agents at once. The present invention may include compositions and methods for detecting infection by Zika virus or another flavivirus, and may distinguish between infections caused by genetically similar agents.

Abstract: This disclosure generally describes to products and compositions relating to a modified Interferometric Reflectance Imaging Sensor (IRIS) platform, wherein said modification relates to, among other things, one or more of a fluidics pathway, a cassette housing for a chip cartridge, a diluted biological specimen and properly labeled gold nanoparticles observed in a wide field-of-view (i.e., not single nanoparticle counting). The present disclosure also includes products and methods that may be used separately or together with the modified IRIS platform, including one or more of a chip spotted with a unique population of purpose-specific test materials, the test materials themselves, a chip cartridge casing, and compositions for use in a fluidics pathway. As contemplated herein, the products and methods disclosed herein may be used for myriad applications, including assessment of overall health, immune profiling abnormal health conditions, including infections and diseases, such as cancer, etc.

Abstract: The present invention relates to compositions and methods involving diagnostic tests with multiple test antigens. The present invention involves the expanded use of test antigens as cross-reactive control antigens (CCAs). The invention advantageously provides for enhanced test results analysis by simultaneously providing both test antigen and CCA signal results. These results, in turn, allow useful sample comparison and cross-reference between samples to more accurately identify and verify the fidelity of test results obtained for multiple infective agents at once. The present invention may include compositions and methods for detecting infection by Zika virus or another flavivirus, and may distinguish between infections caused by genetically similar agents.

Abstract: The present invention provides monoclonal antibodies that are specific for the Dengue non-structural glycoprotein NS1 in monomeric and/or oligomeric (primarily dimeric) form, together with methods, including ELISA and lateral flow assays, that employ the disclosed antibodies for the early detection of Dengue virus infection. Diagnostic kits for the detection of Dengue infection are also provided, such kits including the disclosed monoclonal and/or polyclonal antibodies.

Abstract: A device for performing a multiplex lateral flow immunoassay is provided in which a liquid sample, such as a biological sample, is simultaneously tested for the presence of multiple analytes of interest. Methods that employ the device in the simultaneous detection of multiple analytes of interest within a liquid test sample are also provided.

Abstract: The present invention provides monoclonal antibodies that are specific for the Dengue non-structural glycoprotein NS1 in monomeric and/or oligomeric (primarily dimeric) form, together with methods, including ELISA and lateral flow assays, that employ the disclosed antibodies for the early detection of Dengue virus infection. Diagnostic kits for the detection of Dengue infection are also provided, such kits including the disclosed monoclonal and/or polyclonal antibodies.

Abstract: The present invention provides monoclonal antibodies that are specific for the Dengue non-structural glycoprotein NS1 in monomeric and/or oligomeric (primarily dimeric) form, together with methods, including ELISA and lateral flow assays, that employ the disclosed antibodies for the early detection of Dengue virus infection. Diagnostic kits for the detection of Dengue infection are also provided, such kits including the disclosed monoclonal and/or polyclonal antibodies.