Device and method for detection of analytes
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Publication Number
US-12292449-B2
Publication Date
2025-05-06
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 relates to a portable multiplex analyte detection device and system for predicting cardiac failure in a subject. The device contacts a biological sample and performs at least one detection reaction on a surface comprising a detection region and a separate reference region. The detection region comprises one or more epitope binding agents configured to bind exclusively to analytes, with epitope binding agents specific for at least four biomarkers selected from CCL3, CCL5, CCL18, HFABP, PAPPA, hsCRP, hs cTnI, PIGF, Nt-proBNP, IP-10, MIC-1, cystatin C, and LP PLA2.
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 reference sensors are operated using a balanced sensor method, with the detection region being separate from the reference region. In some embodiments, a light source includes ambient light configured to illuminate both the detection region and the reference region.
The disclosed methods identify the subject as at risk for future cardiac failure when one or more analytes in the biological sample are in the positive range. Diagnostic rules may be applied using a diagnostic database, including post-processing and diagnostic rules via calibration, threshold, and diagnostic databases to classify conditions as negative, indeterminate, or positive.
The document describes longitudinal and inter-study evidence that specific chemokines, especially CCL5 and CCL18 in unstable angina, are differentially regulated versus stabilized patients and decline toward baseline by about 180 days. Temporal profiling links a CCL5 peak to platelet activation using correlations with sCD40L, and the profile supports the involvement of unstable plaques in the source and regulation of CCL18, including feedback related to sCD40L.
Claims Coverage
The provided independent claims center on a device with separated detection and reference regions using balanced sensor detection and at least four biomarker-targeting epitope binding agents, followed by identifying at-risk subjects based on analyte levels in a positive range associated with cardiac failure. One independent claim further specifies analytes comprising nucleotides or nucleotide sequences.
Balanced detection using separate detection and reference regions
A device contacts a biological sample with a surface comprising a detection region and a reference region that are separate, the detection region comprising one or more epitope binding agents; one or more detection sensors sense light associated with the detection region and one or more reference sensors sense light associated with the reference region, and the detection sensors and the reference sensors are operated using a balanced sensor method.
Multiplex biomarker-specific epitope binding agents for positive-range determination
The detection region comprises epitope binding agents specific for at least four biomarkers selected from CCL3, CCL5, CCL18, HFABP, PAPPA, hsCRP, hs cTnI, PIGF, Nt-proBNP, IP-10, MIC-1, cystatin C, and LP PLA2, and detecting whether the level of an analyte is in a positive range associated with cardiac failure.
Risk identification based on analyte positive range associated with cardiac failure
Detecting whether one or more analytes in the biological sample are in the positive range associated with cardiac failure and identifying the subject as at risk for future cardiac failure when one or more analytes are in the positive range.
Nucleotide or nucleotide-sequence analytes bound by epitope binding agents
The epitope binding agents bind exclusively to at least one analyte, wherein the at least one analyte comprises a nucleotide or a nucleotide sequence, while still using separate detection and reference regions, balanced sensor operation, and detecting whether analyte levels are in a positive range associated with cardiac failure.
The independent claims cover predicting cardiac failure by using a device that separates detection and reference regions, applies multiplex biomarker-specific epitope binding agents, employs detection and reference sensors with a balanced sensor method, then detects whether analyte levels fall within a positive range and identifies the subject as at risk for future cardiac failure.
Stated Advantages
Provides prediction of a subject’s future cardiac failure based on whether analyte levels are in a positive range associated with cardiac failure.
Predicting a subject’s cardiac failure by identifying the subject as at risk for future cardiac failure when one or more analytes are in a positive range associated with cardiac failure.
Quartile analyses associate upper CCL5 and CCL18 levels with refractory symptoms and future cardiovascular events.
In mice, CCL3 deficiency is reported to reduce atherosclerotic lesion progression and neutrophil accumulation by altering neutrophil homeostasis and migration.
Documented Applications
Predicting cardiac failure in a subject, including identifying subjects at risk for future cardiac failure.
Predicting imminent cardiac failure within a time window stated in dependent claims.
Targeting cardiac failure selected from acute coronary syndrome and myocardial infarction as specified in dependent claims.
Use of the methods in conjunction with normal diagnostic tests such as electrocardiogram, X-ray of the chest, cardiac stress test, echocardiography, scintigraphy, cardiac index, and determining the level of additional biomarkers as specified in dependent claims.
Acute coronary syndromes, including AMI and unstable angina cohorts.
Recurrent unstable angina.
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