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WO2025207778A1 - Capteur pour quantification rapide et sensible de caractéristiques d'échantillon - Google Patents

Capteur pour quantification rapide et sensible de caractéristiques d'échantillon

Info

Publication number
WO2025207778A1
WO2025207778A1 PCT/US2025/021564 US2025021564W WO2025207778A1 WO 2025207778 A1 WO2025207778 A1 WO 2025207778A1 US 2025021564 W US2025021564 W US 2025021564W WO 2025207778 A1 WO2025207778 A1 WO 2025207778A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample
microprocessor
detecting
oximetry
detection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/021564
Other languages
English (en)
Inventor
Sangmoo Jeong
Geonhui LEE
Jeongyun Kim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johns Hopkins University
Original Assignee
Johns Hopkins University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johns Hopkins University filed Critical Johns Hopkins University
Publication of WO2025207778A1 publication Critical patent/WO2025207778A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326—Magnetic particles
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/475—Assays involving growth factors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5412—IL-6

Definitions

  • the present invention relates generally to detection devices. More particularly the present invention relates to a system for sensing of sample properties.
  • DR diabetic retinopathy
  • AMD age-related macular degeneration
  • angiogenesis factors particularly vascular endothelial growth factor (VEGF) or angiopoietin-2 (Ang-2); the levels of these factors are significantly higher in the aqueous humor of patients with DR or AMD compared to individuals with non-diabetic eye complications and are associated with the disease progression. Therefore, the first-line treatment is the intravitreal injection of angiogenesis inhibitors, such as antibodies targeting VEGF and/or Ang-2.
  • angiogenesis inhibitors such as antibodies targeting VEGF and/or Ang-2.
  • DR and AMD are mainly determined by angiogenesis factors, such as VEGF and Ang-2. Therefore, their levels in the aqueous humor can be a predictive biomarker for treatment response.
  • angiogenesis factors such as VEGF and Ang-2. Therefore, their levels in the aqueous humor can be a predictive biomarker for treatment response.
  • inaccurate or delayed treatments result in permanent visual loss, and unnecessary injection of corticosteroids causes severe side effects, such as glaucoma.
  • the cost of intravitreal drug injection can be more than $20,000 per year for a patient.
  • a system is composed of an oximetry module wherein the oximetry module includes a light source, and wherein the oximetry module is configured to receive light from the light source after it is passed through a sample.
  • the system also includes a microprocessor configured to receive data from the oximetry module.
  • the microprocessor is also configured to determine characteristics about the sample.
  • the system includes a sample well.
  • the system includes a shelf for receiving the sample well.
  • the system includes a pair of oximetry modules in some embodiments, and in others the system includes four oximetry modules.
  • the number of sample wells can be disposed in a sample tray, and the number of sample wells can correspond to the number of oximetry modules.
  • the system is configured for detecting a target protein.
  • the system is configured for detection of target proteins such as vascular endothelial growth factor (VEGF), angiopoietin-2 (Ang-2), PATENT Page 3 P18228_02 monocyte chemoattractant protein-1 (MCP-1), and interleukin-6 (IL-6).
  • VEGF vascular endothelial growth factor
  • Ang-2 angiopoietin-2
  • MCP-1 monocyte chemoattractant protein-1
  • IL-6 interleukin-6
  • the system can be configured for detecting more than one target protein simultaneously.
  • the microprocessor further comprises a display. The microprocessor is configured to transmit data wirelessly.
  • a method for detecting characteristics of a sample includes applying light to the sample, wherein the light is a predetermined wavelength. The method includes detecting the light passed through the sample with an oximetry module. Further, the method includes processing data from the oximetry module with a microprocessor to determine characteristics of the sample. [0008] In accordance with another aspect of the present invention, the method includes displaying data about the sample on a display of the microprocessor. The method includes transmitting data from the microprocessor. The method includes wirelessly transmitting the data. The method includes detecting the presence of a target protein. The method includes detecting a concentration of a target protein.
  • FIGS.3A and 3B illustrate graphical views of performance between the present invention and conventional analytical technologies.
  • FIG.4A-4D illustrate graphical views of detection of four different protein targets using iMOS.
  • FIGS.5A and 5B illustrate graphical views of detection of spiked concentrations of target proteins in human aqueous humor. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0016]
  • the present invention measures the optical signals generated by enzymes attached to the target molecules
  • the device and method of the present invention can be applied more broadly to a variety of molecular detection, including proteins, metabolites, nucleic acids (e.g., DNAs or RNAs), toxins, heavy metals, and pathogens (e.g., virus and bacteria).
  • An exemplary Immuno-Magnetic Oximeter-based Sensor (iMOS) of the present invention include 4 channels with a high sensitivity ( ⁇ 10 pg/mL) and a wide detection range (10-1000 pg/mL). Its detection power comes from an oximeter module, which is widely used in a portable fingertip pulse oximeter device.
  • a sample plate 24 is positioned below the oximetry module PCB 14. As illustrated in FIG.1C, the sample plate 24 includes four wells 26, which correspond to the number of embedded oximetry units 16. As noted above, the number of wells 26 can be increased or decreased based on the testing being done.
  • an aqueous humor sample ⁇ 50 ⁇ L
  • immunoassay reagents containing magnetic beads coated with capture antibodies (cAb) and detector antibodies (dAb) conjugated with horseradish peroxidase (HRP) enzymes.
  • cAb capture antibodies
  • dAb detector antibodies conjugated with horseradish peroxidase
  • HRP horseradish peroxidase
  • TMB peroxidase chromogenic substrate
  • FIGS.3A and 3B illustrate graphical views of performance between the present invention and conventional analytical technologies.
  • FIG.3A illustrates that the ability to measure the absorbance of oxidized TMB was compared between the iMOS system and a conventional plate reader. A dilution series of HRP enzymes was reacted with TMB, and the PATENT Page 9 P18228_02 absorbance at 660 nm was measured.
  • VEGF recombinant proteins as illustrated in FIG.5A and MCP-1 recombinant proteins, as illustrated in FIG.5B were spiked into human aqueous humor samples and quantified using iMOS.
  • the measured concentrations closely matched the expected increases from the spiked amounts compared to the non-spiked control (Ctrl), demonstrating the system's accuracy.
  • Ctrl non-spiked control
  • the system of the present invention is designed to test 80-100 mL of aqueous humor from the eye to analyze the cytokines.
  • the cytokine profile is provided within approximately 90 minutes.
  • a doctor can then deliver more precise treatment to the patient.
  • the sensitivity of the assay can be optimized with programming of the oximetry module as well as the microprocessor and user interface within the application.
  • the steps of the method described can be carried out using a microprocessor, a computer, a smartphone, a computer processing device, non- transitory computer readable medium, or alternately a computing device, microprocessor, or other computer type device independent of or incorporated with the present invention.
  • An independent computing device can be networked together with the device either with wires or wirelessly. Indeed, any suitable method of analysis known to or conceivable by one of skill in the art could be used. It should also be noted that while specific equations are detailed herein, variations on these equations can also be derived, and this application includes any such equation known to or conceivable by one of skill in the art. [0032]
  • a non-transitory computer readable medium is understood to mean any article of manufacture that can be read by a computer.
  • Such non-transitory computer readable media includes, but is not limited to, magnetic media, such as a floppy disk, flexible disk, hard disk, reel-to-reel tape, cartridge tape, cassette tape or cards, optical media such as CD-ROM, writable compact disc, magneto-optical media in disc, tape or card form, and paper media, such as punched cards and paper tape.
  • PATENT Page 11 P18228_02 [0033]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Analytical Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

Un dosage et un dispositif permettent une détection rapide et efficace des caractéristiques d'un échantillon. Le dispositif de la présente invention exploite la puissance de détection d'un module oxymètre. La lumière traverse un échantillon puis est détectée par le module oxymètre, fournissant des informations précieuses sur le contenu de l'échantillon. Le dispositif peut être utilisé pour déterminer certaines caractéristiques d'un échantillon, y compris la présence d'un analyte cible. Dans un exemple d'application, le dispositif peut être utilisé pour la détection de biomolécules cibles, telles que des protéines, y compris, par exemple, le facteur de croissance de l'endothélium vasculaire (VEGF), l'angiopoïétine-2 (Ang-2), la protéine chimiotactique monocytaire-1 (MCP-1) et l'interleukine-6 (IL-6).
PCT/US2025/021564 2024-03-26 2025-03-26 Capteur pour quantification rapide et sensible de caractéristiques d'échantillon Pending WO2025207778A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463570086P 2024-03-26 2024-03-26
US63/570,086 2024-03-26

Publications (1)

Publication Number Publication Date
WO2025207778A1 true WO2025207778A1 (fr) 2025-10-02

Family

ID=97219494

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/021564 Pending WO2025207778A1 (fr) 2024-03-26 2025-03-26 Capteur pour quantification rapide et sensible de caractéristiques d'échantillon

Country Status (1)

Country Link
WO (1) WO2025207778A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130324816A1 (en) * 2012-05-03 2013-12-05 Vioptix, Inc. Robust Calibration and Self-Correction for Tissue Oximetry Probe
US20190346434A1 (en) * 2016-01-27 2019-11-14 The General Hospital Corporation Magnetic Electrochemical Sensing
US20210085228A1 (en) * 2016-12-22 2021-03-25 Cercacor Laboratories, Inc. Methods and devices for detecting intensity of light with translucent detector
US20210302443A1 (en) * 2018-08-27 2021-09-30 Siemens Healthcare Diagnostics Inc. Improved analyte detection system, and methods of use related thereto
WO2022256580A1 (fr) * 2021-06-02 2022-12-08 Richard Postrel Biodétection instantanée pour la détection de maladies à apparition précoce
US20240081699A1 (en) * 2021-05-23 2024-03-14 Vydar Medical Wireless tissue oxygenation monitoring device

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130324816A1 (en) * 2012-05-03 2013-12-05 Vioptix, Inc. Robust Calibration and Self-Correction for Tissue Oximetry Probe
US20190346434A1 (en) * 2016-01-27 2019-11-14 The General Hospital Corporation Magnetic Electrochemical Sensing
US20210085228A1 (en) * 2016-12-22 2021-03-25 Cercacor Laboratories, Inc. Methods and devices for detecting intensity of light with translucent detector
US20210302443A1 (en) * 2018-08-27 2021-09-30 Siemens Healthcare Diagnostics Inc. Improved analyte detection system, and methods of use related thereto
US20240081699A1 (en) * 2021-05-23 2024-03-14 Vydar Medical Wireless tissue oxygenation monitoring device
WO2022256580A1 (fr) * 2021-06-02 2022-12-08 Richard Postrel Biodétection instantanée pour la détection de maladies à apparition précoce

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