Device and method for detection of analytes
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Publication Number
US-11802880-B2
Publication Date
2023-10-31
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
The invention provides a method for detection of one or more analytes in a subject by obtaining a biological sample and contacting a device that includes a surface having a detection region and a reference region. The detection region comprises one or more epitope binding agents configured to bind exclusively to one of the at least one analytes, and at least one analyte is an antibody.
The device 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, so that detection relies on a differential relationship between detection-region light sensing and reference-region light sensing to quantify analyte levels.
In dependent variations, the epitope binding agents can be selected from aptamers, double stranded DNA sequence, ligands, ligand fragments, receptors, receptor fragments, antibodies, antibody fragments, coenzymes, coregulators, allosteric molecules, ions, or combinations thereof. The method can further use a constrained biomarker panel where the epitope binding agents are specific for at least four selected biomarkers, and it can determine subject status using predefined positive ranges for the analytes.
The disclosed approach can compare biomarker levels from a subject with a reference biomarker level from a healthy control sample and determine whether they differ. It can then relate biomarker difference and normal diagnostic tests to an imminent cardiac failure determination, including risk for imminent cardiac failure when one or more analytes are in the positive range.
Claims Coverage
The independent claim is a method for detecting one or more analytes in a subject using a detection-region/reference-region device with epitope binding agents and balanced light sensing. The dependent claims refine epitope-binding agent categories, constrain sample and biomarker panel choices, and add quantitative positive ranges and diagnostic logic tied to cardiac failure risk.
Detection region with exclusive epitope binding agents
A device surface comprising a detection region including one or more epitope binding agents, wherein each epitope binding agent is configured to bind exclusively to one of the at least one analytes (at least one analyte is an antibody).
Reference region with reference light sensing
A reference region on the device surface together with one or more reference sensors to sense light associated with the reference region.
Balanced sensor method using detection and reference sensors
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, operated using a balanced sensor method.
Detection of analyte levels using the balanced differential sensing
Detecting with the device the level of the one or more analytes after contacting the device with the biological sample.
Positive-range-based imminent cardiac failure determination
Detecting whether specified analyte levels fall within predefined positive ranges and identifying the subject as at risk for cardiac failure when one or more analytes are in the positive range, including the use of normal diagnostic tests such that biomarker difference and negative normal diagnostic test results indicate imminent cardiac failure.
Across the claim set, the core coverage centers on exclusive epitope binding agents in a detection region paired with a reference region and detection/reference sensors operated by a balanced sensor method, followed by detection of analyte levels and, in dependent claims, classification tied to predefined positive ranges and imminent cardiac failure risk.
Stated Advantages
Balanced sensor operation using detection and reference regions for sensing light associated with detection and reference locations.
Predictive/prognostic potential for chemokines associated with unstable angina outcomes, including CCL5 and CCL18.
Ability to determine that analyte levels fall within predefined positive ranges to identify subjects at risk for cardiac failure.
Use of reference-control biomarker comparison and negative normal diagnostic test results to indicate imminent cardiac failure.
Documented Applications
Detection of one or more analytes in a subject using a device with detection and reference regions and balanced sensor operation.
Use of biomarker panels, including chemokines such as CCL3, CCL5, and CCL18 among others, with predefined positive ranges to identify a subject at risk for cardiac failure or imminent cardiac failure.
Clinical and experimental assessment of chemokines, especially CCL5 and CCL18, in relation to unstable angina outcomes and immune receptor regulation.
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