Device and method for detection of analytes
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Publication Number
US-10564166-B2
Publication Date
2020-02-18
Expiration Date
Abstract
A detection device and associated systems and methods for detecting analytes from a multiplex reaction are described. In particular, a device for conducting at least one detection reaction using a modified ELISA method including a surface with a detection region and a reference region, a detection sensor, and a light source. The detection device may include a complementary metal-oxide-semiconductor (CMOS) image sensor. The device may be used to measure and report discrete quantities or combinations of discrete analytes, providing information to aid in the prognosis and/or diagnosis of altered states of health in vertebrates.
Core Innovation
A method is provided for detection of one or more analytes in a subject by obtaining a biological sample and contacting a device with the sample. The device includes a surface having a detection region and a reference region, and the detection region comprises one or more epitope binding agents configured to bind exclusively to one of the at least one analytes.
The device further includes one or more detection sensors to sense light associated with the detection region and one or more reference sensors to sense light associated with the reference region. The detection sensors and the reference sensors are operated using a balanced sensor method, and the device detects the level of the one or more analytes based on the sensed light.
The detected analyte levels are evaluated for prognostic or diagnostic assessment, including future cardiac failure or imminent cardiac failure determinations. Biomarker criteria include positive ranges indicated in Table A and biomarker comparisons to healthy-control reference levels, with normal diagnostic test results used in the assessment of imminent cardiac failure.
Claims Coverage
The consolidated independent claim coverage includes 2 core inventive features for analyte detection, with dependent refinements for binding agent selection, sample types, biomarker composition, and cardiac-failure-related evaluation.
Balanced detection with detection and reference regions
Contacting a device with a biological sample, wherein the device includes a surface having a detection region with one or more epitope binding agents and a reference region, with detection sensors sensing light from the detection region and reference sensors sensing light from the reference region, operated using a balanced sensor method, to detect the level of the one or more analytes.
Exclusive epitope binding agent selection
Employing one or more epitope binding agents configured to bind exclusively to one of the at least one analytes, wherein the epitope binding agents are selected from apatmers, double stranded DNA sequence, ligands, ligand fragments, receptors, receptor fragments, antibodies, antibody fragments, coenzymes, coregulators, allosteric molecules, ions, or combinations thereof.
Cardiac failure risk evaluation using Table A positive ranges and healthy-control comparisons
Detecting whether the level of one or more analytes is in the positive range indicated in Table A, identifying the subject as at risk for future cardiac failure when one or more analytes are in that positive range, and comparing biomarker levels to a healthy-control reference level, determining whether they are significantly different, conducting normal diagnostic tests, and indicating imminent cardiac failure when significant biomarker differences and negative normal diagnostic test results are present.
The claim coverage is directed to analyte detection using a detection-region epitope binding arrangement with exclusive binding and paired detection/reference light sensing operated via a balanced sensor method, and it extends to cardiac-failure risk evaluation using Table A positive ranges and healthy-control reference comparisons combined with normal diagnostic test outcomes.
Stated Advantages
Enables detection of the level of one or more analytes using paired detection and reference sensors operated using a balanced sensor method.
Supports identification of subjects at risk for future cardiac failure based on analyte levels in Table A positive ranges.
Supports indication of imminent cardiac failure by comparing biomarker levels to a healthy-control reference level and incorporating negative normal diagnostic test results.
Documented Applications
Prognostic and diagnostic assessment for future cardiac failure and imminent cardiac failure using detected analyte/biomarker levels, including criteria based on Table A positive ranges and healthy-control reference level comparisons.
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