Devices and formulations for detecting, screening and monitoring levels of certain constituents in bodily fluids and method
Inventors
Altschul, Randice Lisa • Theise, Neil David • Rapkin, Myron • O'Brien, Rebecca
Assignees
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Publication Number
US-9957547-B2
Publication Date
2018-05-01
Expiration Date
Abstract
A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.
Core Innovation
The invention relates to non-invasive analysis of bodily fluids using colorimetric, dry-reagent and lateral-flow devices, where binding of a detection reagent to an analyte provides a visual indication of the presence and level of the analyte. Chromagen-laden carrier members are prepared and configured to form an indicator formulation that changes color when exposed to an analyte, enabling detection and quantification in bodily fluid samples such as saliva, serum, and plasma.
The disclosed detector formats use constituent-specific detection reagents that specifically bind to selected analytes. Example analytes include glucose, cholesterol, alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and the detection reagents can include polyclonal antibodies, monoclonal antibodies, synthetic mono-, oligo- and polysaccharides, lectins, avidin and streptavidin, biotin, and combinations thereof.
The invention further connects analyte panels to screening for liver cancer NAFLD-associated malignancies, where screening is positive when elevated levels of at least three analytes selected from glucose, cholesterol, ALT, and AST are detected relative to a predetermined reference range and/or a control sample. Documented device concepts include visual color gauges and reader algorithms for digital readouts, and marker combinations are used in screening contexts associated with NAFLD/NASH and elevated liver cancer risk (including hepatocellular carcinoma (HCC)).
Claims Coverage
The partial content provides two independent method claims. Across both independent claims, the inventive coverage centers on detecting analytes (glucose, cholesterol, ALT, AST) via detection reagents that specifically bind and produce a visual indication, and declaring a NAFLD-associated malignancy screening-positive result based on detecting elevated levels of at least three of the analytes relative to a reference range and/or control sample. The independent claims differ mainly in whether the method provides a plurality of detector devices or a single detector device.
Visual binding-based analyte detection using specific detection reagents
A biological sample is obtained, a detector device (or each detector device) includes detection reagents that specifically bind an analyte selected from glucose, cholesterol, ALT, AST and combinations thereof, wherein the binding provides a visual indication of the presence and level of analyte in the sample.
Screening-positive criterion based on at least three elevated analytes relative to reference or control
Screening is positive for NAFLD-associated malignancies if elevated levels of at least three analytes selected from glucose, cholesterol, ALT, and AST relative to a predetermined reference range and/or control sample analyte are detected.
Screening using multiple detector devices
Providing a plurality of detector devices, each detector device comprising a plurality of detection reagents which specifically binds to analytes selected from glucose, cholesterol, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and combinations thereof, with visual indication of presence and level, followed by applying the sample to at least one of the plurality of detector devices and ascertaining the presence and level of analyte in the sample.
Screening using a detector device with a plurality of detection reagents
Providing a detector device comprising a plurality of detection reagents which specifically binds an analyte selected from glucose, cholesterol, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and combinations thereof, with visual indication of presence and level, followed by applying the sample to the detector device and ascertaining the presence and level of analyte in the sample.
Overall, the claim coverage focuses on a visual, binding-based analyte detection approach using specified detection reagents for glucose, cholesterol, ALT, and AST, combined with an explicit NAFLD-associated malignancies screening-positive threshold requiring elevated levels of at least three analytes relative to a predetermined reference range and/or control sample.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Screening for liver cancer NAFLD-associated malignancies in a patient by detecting analyte levels (glucose, cholesterol, ALT, AST) and declaring the screening-positive condition when at least three analytes are elevated relative to a predetermined reference range and/or control sample analyte.
Screening using marker combinations (glucose, cholesterol, ALT, AST) associated with NAFLD/NASH and elevated NAFLD-associated liver cancer risk, including hepatocellular carcinoma (HCC).
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