WO2023101568A1 - Sensor for electrochemical detection - Google Patents

Sensor for electrochemical detection Download PDF

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Publication number
WO2023101568A1
WO2023101568A1 PCT/PL2021/000089 PL2021000089W WO2023101568A1 WO 2023101568 A1 WO2023101568 A1 WO 2023101568A1 PL 2021000089 W PL2021000089 W PL 2021000089W WO 2023101568 A1 WO2023101568 A1 WO 2023101568A1
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WO
WIPO (PCT)
Prior art keywords
sensor
housing
electrode
pathogens
buttons
Prior art date
Application number
PCT/PL2021/000089
Other languages
French (fr)
Inventor
Bartlomiej DEC
Paulina CIECWIERZ
Wiktoria Lenart
Dawid NIDZWORSKI
Wioleta BIALOBRZESKA
Original Assignee
Sensdx S.A.
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 Sensdx S.A. filed Critical Sensdx S.A.
Publication of WO2023101568A1 publication Critical patent/WO2023101568A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3273Devices therefor, e.g. test element readers, circuitry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1477Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means non-invasive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/07Home care
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0406Constructional details of apparatus specially shaped apparatus housings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0406Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0425Ergonomically shaped housings

Definitions

  • the subject of the utility model is a sensor for electrochemical detection of biological material for the presence of pathogens, especially for the detection of Influenza bacillus bacterium (Heamophilus influenzae), rhinoviruses, Herpes simplex virus, Pseudomonas syringae pv. Lachrymans.
  • Influenza bacillus bacterium Heamophilus influenzae
  • rhinoviruses Herpes simplex virus
  • a system for detecting the sequence of nucleic acids, based on the electrochemical method uses an electrode on a PCB substrate, consisting of a matrix of working and reference electrodes.
  • the electrical potential applied to the working electrode is multiplexed, which allows for detecting of different ligands in one sample.
  • the sensor electrode is connected to an analyzer which reads electrical pulses and signal changes caused by the interaction on the electrode.
  • Ru.70037 Y1 a sensor for electrochemical analysis of biological materials is known, which has two three-layer electrodes working in the form of two separated circles with a diameter of 0.2 mm, around which there is a two-layer closing electrode in the form of a circle segment, and the reference electrode has the form of a circle segment and is five times smaller than the closing electrode, with the sensor having a single-layer connector in the form of five, and in the central part of four parallel lines connected to each of the electrodes.
  • Patent application US2014273549A1 presents a solution which concerns a multielectrode biometric sensor (e.g. for measuring blood glucose) in the form of a strip connected to the reading device via a socket. There are many fields made of conductor on the strip, and the edge of the strip is formed to fit the reading socket and is equipped with many contacts.
  • the described device has one measuring segment consisting of several electrodes.
  • the purpose of presented utility model is to create a new sensor for the electrochemical detection of various pathogens, in particular for reusable use.
  • the subject of the utility model is a sensor for electrochemical detection of biological material for the presence of pathogens, which is in the shape of a rectangle with rounded sides with an upper housing and a lower housing, where in the upper housing in its upper part there is a screen, and under it there are buttons, while in the lower part of the sensor, under the buttons there is a sensor connector, in which a fixed sensory platform is placed, which contains a working electrode with a partial housing, while inside the sensor housing and there is a printed circuit board (PCB) along the entire length of the sensor.
  • PCB printed circuit board
  • a sensor in which the electrode together with the housing is in the form of a retractable element.
  • Sensor can have from 1 to 4 electrodes.
  • Sensor is rectangular in shape with rounded sides.
  • Sensor has a height of 200 mm, a width of 90 mm, a thickness of 27 mm.
  • Fig. 1 - presents a sensor for electrochemical detection in cross-section.
  • Fig.2 - presents a block diagram of the sensor system for electrochemical detection, more precisely four main executive blocks: a) control block, b) power block, c) measuring block, d) display block.
  • Fig. 3 - shows the sensor in front view as well as side view.
  • Fig. 4 - shows the sensor in front view with an indication of the sensor connector (insertable electrode element) and the USB port.
  • Fig. 5 - shows a retractable element in the form of an electrode with a housing.
  • the sensor which is the subject of the utility model, is presented in the example of implementation and in the drawing in which fig. 1 -5 present a sensor for electrochemical detection of biological material for the presence of pathogens.
  • the sensor for electrochemical detection is in the shape of a rectangle with rounded sides, with a height of 200 mm, a width of 90 mm and a thickness of 27 mm, it consists of an upper housing (1) and a lower housing (2).
  • the upper housing (1) in its upper part there is a screen (3), and under it there are navigation buttons (7).
  • the lower part of the sensor more precisely under the buttons (7) there is an input / connector of the sensor. This is the place where a fixed sensory platform is inserted, which contains the working electrode (5), it is a carbon or diamond electrode.
  • the electrode (5) has a housing (6) which covers the part of the electrode located outside the sensor. The remaining part of the electrode (5) is inserted into the sensor.
  • the electrode (5) together with the housing (6) has the form of a retractable element.
  • the sensor can have from 1 to 4 electrodes. Inside the sensor housing (1) and (2), under the screen (3) and buttons (7) along the entire length there is a PCB (4), on which there is a circuit connecting the reader with the analytical surface, i.e. the electrode.
  • the sensor contains a carbon or diamond electrode (5) for detecting selected pathogens.
  • a detection layer is attached to the electrode (5) by means of a linker in the form of reduced diazonium salt: antibodies of selected pathogens applied to a permanent platform modified with a linker using an EDC/NHS linker.
  • Biological material is applied to the retractable element in the form of an electrode (5), more precisely in a place without a housing (6).
  • pathogens and specific protein biomarkers were made, the detection of which was carried out using a sensor.
  • the selection of pathogens consisted in selecting those which are problematic for human health and not only, four potential pathogens were selected:
  • Influenza bacillus bacterium Heamophilus influenzae

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Optics & Photonics (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Electrochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

The subject of the utility model is a sensor for electrochemical detection of biological material for the presence of pathogens, which is in the shape of a rectangle with rounded sides with an upper housing (1) and a lower housing (2), where in the upper housing (1) in its upper part there is a screen (3), and under it there are buttons (7), while in the lower part of the sensor, under the buttons (7) there is a sensor connector, in which a fixed sensory platform is placed, which contains a working electrode (5) with a partial housing (6), while inside the sensor housing (1) and (2), there is a printed circuit board (PCB) (4) along the entire length of the sensor.

Description

Sensor for electrochemical detection
The subject of the utility model is a sensor for electrochemical detection of biological material for the presence of pathogens, especially for the detection of Influenza bacillus bacterium (Heamophilus influenzae), rhinoviruses, Herpes simplex virus, Pseudomonas syringae pv. Lachrymans.
From the description of the US 6391558 Bl, a system for detecting the sequence of nucleic acids, based on the electrochemical method, is known. The system uses an electrode on a PCB substrate, consisting of a matrix of working and reference electrodes. The electrical potential applied to the working electrode is multiplexed, which allows for detecting of different ligands in one sample. The sensor electrode is connected to an analyzer which reads electrical pulses and signal changes caused by the interaction on the electrode.
From another description of the US 20030042150 Al, an electrochemical sensor for detecting blood parameters such as glucose, cholesterol and others is known. The system consists of many electrodes, which allows for simultaneous quantitative measurement of numerous parameters.
From the description of the utility model Ru.70037 Y1 a sensor for electrochemical analysis of biological materials is known, which has two three-layer electrodes working in the form of two separated circles with a diameter of 0.2 mm, around which there is a two-layer closing electrode in the form of a circle segment, and the reference electrode has the form of a circle segment and is five times smaller than the closing electrode, with the sensor having a single-layer connector in the form of five, and in the central part of four parallel lines connected to each of the electrodes.
Patent application US2014273549A1 presents a solution which concerns a multielectrode biometric sensor (e.g. for measuring blood glucose) in the form of a strip connected to the reading device via a socket. There are many fields made of conductor on the strip, and the edge of the strip is formed to fit the reading socket and is equipped with many contacts. The described device has one measuring segment consisting of several electrodes. The purpose of presented utility model is to create a new sensor for the electrochemical detection of various pathogens, in particular for reusable use.
The subject of the utility model is a sensor for electrochemical detection of biological material for the presence of pathogens, which is in the shape of a rectangle with rounded sides with an upper housing and a lower housing, where in the upper housing in its upper part there is a screen, and under it there are buttons, while in the lower part of the sensor, under the buttons there is a sensor connector, in which a fixed sensory platform is placed, which contains a working electrode with a partial housing, while inside the sensor housing and there is a printed circuit board (PCB) along the entire length of the sensor.
A sensor in which the working electrode is a carbon or diamond electrode which has a housing that covers part of the electrode located outside the sensor, the remaining part of the electrode is inserted into the sensor.
A sensor in which the electrode together with the housing is in the form of a retractable element.
Sensor can have from 1 to 4 electrodes.
Sensor, where on the PCB there is a circuit connecting the reader with the analytical surface, i.e. the electrode.
Sensor is rectangular in shape with rounded sides.
Sensor has a height of 200 mm, a width of 90 mm, a thickness of 27 mm.
Description of the figures
Fig. 1 - presents a sensor for electrochemical detection in cross-section.
Fig.2 - presents a block diagram of the sensor system for electrochemical detection, more precisely four main executive blocks: a) control block, b) power block, c) measuring block, d) display block.
Fig. 3 - shows the sensor in front view as well as side view. Fig. 4 - shows the sensor in front view with an indication of the sensor connector (insertable electrode element) and the USB port.
Fig. 5 - shows a retractable element in the form of an electrode with a housing.
The sensor, which is the subject of the utility model, is presented in the example of implementation and in the drawing in which fig. 1 -5 present a sensor for electrochemical detection of biological material for the presence of pathogens.
The sensor for electrochemical detection is in the shape of a rectangle with rounded sides, with a height of 200 mm, a width of 90 mm and a thickness of 27 mm, it consists of an upper housing (1) and a lower housing (2). In the upper housing (1) in its upper part there is a screen (3), and under it there are navigation buttons (7). In the lower part of the sensor, more precisely under the buttons (7) there is an input / connector of the sensor. This is the place where a fixed sensory platform is inserted, which contains the working electrode (5), it is a carbon or diamond electrode.
The electrode (5) has a housing (6) which covers the part of the electrode located outside the sensor. The remaining part of the electrode (5) is inserted into the sensor. The electrode (5) together with the housing (6) has the form of a retractable element. The sensor can have from 1 to 4 electrodes. Inside the sensor housing (1) and (2), under the screen (3) and buttons (7) along the entire length there is a PCB (4), on which there is a circuit connecting the reader with the analytical surface, i.e. the electrode.
The sensor contains a carbon or diamond electrode (5) for detecting selected pathogens. A detection layer is attached to the electrode (5) by means of a linker in the form of reduced diazonium salt: antibodies of selected pathogens applied to a permanent platform modified with a linker using an EDC/NHS linker.
Biological material is applied to the retractable element in the form of an electrode (5), more precisely in a place without a housing (6).
The group of selected sensor antibodies is characterized by:
• specificity to whole pathogens or external proteins of pathogens (monoclonal antibodies),
• high efficiency in low concentrations (high dilutions, at the range of 1000 x dilutions), • structural stability in the selected measuring electrolyte and its pH (pH close to 7),
• stability in electrochemical measurements (measurement repeatability for selected methods of electrochemical impedance spectroscopy - EIS and cyclic voltammetry - CV):
- for each sensory substrate used,
- in time,
- in cyclic changes in temperature and humidity,
- for different methods of anchoring antibodies,
• high sensitivity in the electrochemical signal (visible changes in impedance at the time of detection of the analyte, i.e. antibody-antigen, protein-protein interactions),
• lack of interaction with negative controls (buffers, other non-specific pathogens - cells and cell components, components of swabs, saliva tests),
• high sensitivity, low limits of detection of proteins and pathogens (for proteins of pathogens at the range of picograms I ml, for entire pathogens at the range of several - several dozen cells) to detect human infections and not only, in the early stages,
• linear response characteristics in the electrochemical signal.
A selection of pathogens and specific protein biomarkers was made, the detection of which was carried out using a sensor. The selection of pathogens consisted in selecting those which are problematic for human health and not only, four potential pathogens were selected:
• Influenza bacillus bacterium (Heamophilus influenzae),
• Rhinovirus,
• Herpex simplex virus
Pseudomonas syringae pv. Lachrymans. Description of the indications:
1. indicates upper housing.
2. indicates lower housing.
3. indicates Screen.
4. indicates PCB.
5. indicates electrode.
6. indicates electrode housing.
7. indicates buttons.

Claims

6 Claims:
1. Sensor for electrochemical detection of biological material for the presence of pathogens is characterized in that it is the shape of rectangle with rounded sides with an upper housing (1) and a lower housing (2), where in the upper housing (1) in its upper part there is a screen (3), and under it there are buttons (7), while in the lower part of the sensor, under the buttons (7) there is a sensor connector, in which a fixed sensory platform is placed, which contains a working electrode (5) with a partial housing (6), while inside the sensor housing (1) and (2) , there is a printed circuit board (PCB) (4) along the entire length of the sensor.
2. Sensor according to claim 1, characterized in that the working electrode (5) is a carbon or diamond electrode that has a housing (6) which covers part of the electrode located outside the sensor, the remaining part of the electrode (5) is inserted into the sensor.
3. Sensor according to claim 1 - 2, characterized in that the electrode (5) together with the housing (6) has the form of a retractable element.
4. Sensor according to claim 1 - 2, characterized in that the sensor can have from 1 to 4 electrodes (5).
5. Sensor according to claim 1 is characterized in that on the PCB (4) there is a circuit connecting the reader with the analytical surface, i.e. the electrode (5).
6. The sensor according to claim 1 is characterized in that it is in the shape of a rectangle with rounded sides.
7. The sensor according to claim 6 is characterized in that it has a height of 200 mm, a width of 90 mm, a thickness of 27 mm.
PCT/PL2021/000089 2021-11-30 2021-12-01 Sensor for electrochemical detection WO2023101568A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PLW.130431 2021-11-30
PL130431U PL130431U1 (en) 2021-11-30 2021-11-30 Sensor for electrochemical detection

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WO2023101568A1 true WO2023101568A1 (en) 2023-06-08

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006070199A1 (en) * 2004-12-29 2006-07-06 Lifescan Scotland Limited An analyte test meter having a test sensor port
US20140131199A1 (en) * 2008-07-17 2014-05-15 Abbott Diabetes Care Inc. Analyte Measurement Devices and Systems, and Components and Methods Related Thereto
US20170343532A1 (en) * 2016-05-25 2017-11-30 Roche Diabetes Care, Inc. Medical device with a twisting button giving the impression to be part of a display window

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006070199A1 (en) * 2004-12-29 2006-07-06 Lifescan Scotland Limited An analyte test meter having a test sensor port
US20140131199A1 (en) * 2008-07-17 2014-05-15 Abbott Diabetes Care Inc. Analyte Measurement Devices and Systems, and Components and Methods Related Thereto
US20170343532A1 (en) * 2016-05-25 2017-11-30 Roche Diabetes Care, Inc. Medical device with a twisting button giving the impression to be part of a display window

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Neuca: coronavirus test in 6 minutes", 29 July 2020 (2020-07-29), pages 1 - 4, XP055949553, Retrieved from the Internet <URL:https://healthcaremarketexperts.com/en/news/technology/neuca-coronavirus-test-in-6-minutes/> [retrieved on 20220806] *

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